Pharmaceutical News Live

AstraZeneca is to cut a further 7,300 jobs

2012-02-08T02:46:00.000-08:00

AstraZeneca is to cut a further 7,300 jobs over the next two years as part of a restructuring initiative to save US$1.6bn a year.

The redundancies come on top of a programme of 9,000 job losses announced in 2010.

The Anglo-Swedish pharmaceutical giant also announced a fall in pre-tax profit for the three months to the end of December 2011 to $2.05bn compared with $2.28bn in 2010. Revenue in Q4 was unchanged at $8.6m on constant exchange rates.

Full-year revenues were down 2% at constant exchange rates to $33.3bn after the firm lost nearly $2bn in sales to generic competition and $1bn because of government prices.

Despite the challenges, AstraZeneca is committed to returning cash to shareholders and plans to buy back $4.5bn in shares in 2012.

David Brennan, chief executive, said: ‘Disciplined execution of our strategy has delivered a good performance in 2011 in the face of intensified pricing pressure and generic competition.

‘While the further expected losses of market exclusivity make for a challenging 2012 outlook, we remain committed to a long-term, focused, r&d based strategy, and today we have announced further steps to drive productivity in all areas to improve returns on our investment in innovation.’

He added that the job cuts should be seen in the context of AstraZeneca taking ‘decisive steps to improve returns on investment’.

‘We continue to reshape our business to improve productivity and innovation and with it our long-term ability to compete in a rapidly changing healthcare environment,’ he said.

The firm will continue to drive efficiencies in its Selling, General and Administrative (SG&A) functions by rationalising non-customer facing support groups and introducing new ways of meeting customer needs.

The number of sales and marketing regions has already been reduced from five to three and smaller countries are being clustered to ‘optimise resources, increase shared services and reduce the cost base’.

In parallel, AstraZeneca is accelerating its use of new customer channels, including digital technology and the use of call centres for sales and medical advice.

The company currently estimates that approximately 3,750 will go in SG&A as a result of this reorganisation.

A focus for much of the change in r&d is the neuroscience therapy area and AstraZeneca believes that it will have the best chance of success in future by combining the company’s internal expertise with innovative external science.

As a result, the firm will create a new ‘virtual’ neuroscience Innovative Medicines unit (iMed) made up of a small team of around 40–50 AstraZeneca scientists conducting discovery and development externally, through a network of some of the most innovative partners in academia and industry globally. The team will be based in major neuroscience hubs – Boston (US) and Cambridge (UK) – and work closely with innovative partners such as the Karolinska Institute in Stockholm (Sweden).

Martin Mackay, president of research and development at AstraZeneca, said: ‘The creation of a virtual neuroscience iMed will make us more agile scientifically and financially – we will be able to collaborate flexibly with the best scientific expertise, wherever it exists in the world.’

The implementation of this new model will lead to the loss of 2,200 jobs globally and the end of r&d activity at two sites that are focused on neuroscience: Södertälje in Sweden and Montreal in Canada. Södertälje will remain an important part of the AstraZeneca network and the Montreal facility will close.

As AstraZeneca makes further efficiencies in the supply chain, a further 1,350 jobs will go in support functions in Operations.

Going forward, AstraZeneca said revenue in 2012 would continue to be affected by the anticipated loss of exclusivity for antipsychotic drug Seroquel IR and hypertension drug Atacand globally, and for cholesterol drug Crestor in Canada. The firm therefore anticipates a constant currency revenue decline for 2012 in the low double-digit range.

Pfizer Blames Birth Control Recall On Packaging Error

2012-02-08T00:12:00.000-08:00

Pfizer recalled 1 million packages of birth control pills last Wednesday, as a result of mechanical and vision inspection problems on its packaging line in December 2011. The error caused inexact tablet counts or out-of-sequence tablets in the blister packs. In an investigation, the company discovered 14 lots of Lo-Ovral-28 and 14 lots of the generic norgestrel/ethinyl estradio pills contained incorrect dosing.

A Pfizer spokesperson said an automatic packaging process placed the pills in the wrong order in the packs, meaning that placebo pills were placed where active ingredient pills should have been, and vice versa.

The company believes that only 30 packets of the birth control pills were affected by the mix-up, and that the problem has been identified and fixed.In a statement, Pfizer said this packaging issue shouldn't cause any health risks, but added, "as a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy."The pills were manufactured by Pfizer last year, but marketed by Akrimax Pharmaceuticals.

FIA seals pharmaceutical company

2012-02-01T21:50:00.001-08:00

In an aftermath of 172 deaths of ailing people in Lahore, the Federal Investigation Agency (FIA) on Wednesday raided a pharmaceutical company and recovered 49 kilograms raw material, putting the company owners’ names into the Exit Control List (ECL).

Talking to Daily Times, FIA Sindh Director General Moazzam Jan said that the FIA team, along with Drug Inspectors of Sindh Health Department, raided Efroze Pharmaceuticals at Korangi Industrial Area and seized samples of its raw material.

He said the action was taken in view of a laboratory report that revealed extensive use of anti-malaria substance in the drug samples collected from Efroze Pharmaceuticals on January 26.

Jan said that the raid was conducted on the directives of federal government however no arrest was made. He further added that the pharmaceutical company is owned jointly by Nadir Feroz, Abdullah Feroz, Khurram Munaf, Sultan and Shafiq.

“The FIA would not register a case in Karachi since one had already been registered by Punjab authorities”, he added. Products samples of various medicines including a drug called ‘Isotab’ were impounded while company was sealed till further orders and completion of inquiry. staff report

Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin

2012-02-01T21:46:00.002-08:00

Arena Pharmaceuticals, Inc.ARNA -2.56% and Eisai Inc. announced today that the US Food and Drug Administration (FDA) has notified Arena that an Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the lorcaserin New Drug Application (NDA) resubmission will be held in the second quarter of 2012. Confirmation and details of the meeting will be published in the Federal Register.Lorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition. Arena resubmitted the lorcaserin NDA in December 2011, and the FDA assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012.

Affinium Pharmaceuticals, Ltd., Announces First Patient Dosed with Oral AFN-1252 in a Phase 2 Clinical Trial for Acute Bacterial Skin & Skin Structure

2012-02-01T21:46:00.001-08:00

Affinium Pharmaceuticals announced today dosing of the first patient in a multi-center Phase 2 clinical trial evaluating oral AFN-1252 in acute bacterial skin & skin structure infections ("ABSSSI"). The Phase 2 trial is the first human efficacy study conducted with this new class of antibiotic and follows the recently completed Phase 1 trials which demonstrated excellent safety, tolerability and pharmacokinetics of AFN-1252 in single and multiple ascending oral dosages.The Phase 2 study will confirm efficacy and tolerability of 200 mg of oral AFN-1252 dosed twice daily for 5-14 days in patients with staphylococcal skin infections. The trial will also evaluate both the traditional endpoints at end of treatment and early endpoints currently recommended by the FDA."We're on the cusp of delivering human proof-of-concept data for our antibiotic, AFN-1252, with its truly new mechanism of action and unique selective spectrum. Preclinical animal data indicates AFN-1252 has mg/kg efficacy that is significantly improved compared to linezolid; and both single and multiple dose Phase 1 data indicate an excellent safety and tolerability profile. We are confident that the Phase 2 trial will confirm AFN-1252 as a potent and well tolerated anti-Staph antibiotic" commented Dr. Hafkin, Chief Medical Officer of Affinium Pharmaceuticals.According to Leisa Dennehy, Commercial & Corporate Development Advisor at Affinium, "market research with physicians clearly indicates the need for an IV and oral antibiotic with an improved safety profile compared to vancomycin or linezolid, without compromising potency against MRSA. We believe AFN-1252 will provide physicians with a compelling alternative to vancomycin or linezolid in the treatment of known or suspected MRSA infections for patients where vancomycin or linezolid safety risks cannot be tolerated. Additionally, an oral MRSA agent offers a potential pharmacoeconomic advantage by treating patients at home with a safe and potent oral agent, rather than treating in the hospital or out-patient clinic with IV antibiotics."Each year in the US, there are more than ten million patient visits for treatment of skin infections. Staphylococcus is the mostly commonly identified pathogen in skin infections and is a potential pathogen in almost every infection type, making staphylococci the most common pathogen in a large and diverse patient population. "A staphylococcal-specific antibiotic provides the unique benefits of no off-target effects on gut flora and no resistance selection pressure on other bacterial species which greatly reduces the probability of antibiotic associated adverse events such as C. difficile disease, diarrhea or candidiasis, while providing high potency against the desired target", remarked Nachum Kaplan, Ph.D, Vice President of Microbiology at Affinium. "AFN-1252 is like no other antibiotic ever developed, and we look forward to having the Phase 2 data later this year."

World's Leading Pharmaceutical Executives All Converging in Zurich, Switzerland on February 21-22, 2012 for Breakthrough Event

2012-02-01T21:45:00.001-08:00

The buzz is growing stronger and stronger for one of the most talked-about events in 2012- the Pharma CI Europe Conference on February 21-22, 2012 at the Renaissance Zurich Hotel in Switzerland ( http://pharmaciconference.com/ ). "With more than 150 top pharmaceutical executives already attending, people are already saying that this event is sure to make waves among the industry's influential decision makers," says conference organizer Amy Yueh. "After all, this event is the counterpart to our annual Pharma CI USA Conference, scheduled for September 11-12 in Parsippany, New Jersey, which is the largest gathering of biopharma competitive intelligence execs in the world with over 300 CI professionals attending annually."Conference participants will benefit from the impressive speaking faculty of more than 40 expert speakers from prestigious companies like Actelion, Amgen, Bausch + Lomb, Chiesi Farmaceutici, DSM, F. Hoffmann-La Roche, GlaxoSmithKline, Helsinn Healthcare, Johnson & Johnson, MedImmune, Merck, Norbrook, Novartis, Nycomed, Onyx, Pfizer, Sanofi-Aventis, Shire, Takeda, Virbac, and many more!These senior level speakers are prepared to delve deep into meaningful discussions about the latest and most pressing issues. To see the detailed program agenda, go to: http://www.pharmaciconference.com/EUR_program.htmlThe Pharmaceutical Competitive Intelligence Europe Conference provides the ideal atmosphere for learning and debating the industry's most pressing topics. This is the only event that brings together all the industry's decision makers and experts in an atmosphere that promotes gaining insight, developing and solidifying meaningful working relationships, and providing clear directives about the future of this important industry.The 2012 Pharma CI Europe Conference sponsors/exhibitors include the following: Deallus Group; Lifescience Dynamics; Citeline; Pennside; Adis; BioMedTracker; Digimind; Evaluate Pharma; Evalueservce; Financial Times; Fletcher/CSI; Fuld & Company; ISIS; Larvol; PharmaVoxx; Prescient; SAI MedPartners; Sedulo Group; Value Edge.The Pharma CI Conference is THE INDUSTRY'S GOLD STANDARD for senior level pharmaceutical, biotechnology, medical device, and diagnostics professionals seeking the latest news and the industry's best networking opportunities. More than 300 people attended the 2011 event in the U.S., and now it's Europe's turn!

Shylendra Kumar Joins Pharmaceutical eConsulting

2012-02-01T21:43:00.000-08:00

Pharmaceutical eConsulting (PeC) is investing to remain the chosen partner for electronic regulatory submissions services. Today, the company announced the addition of Shylendra Kumar as Senior Principal Consultant. In this role, Mr. Kumar will contribute, together with Yolanda Hall, to the establishment of innovative consulting services for the life science industry, developing strategies and plans to execute the US business.Mr. Kumar brings more than 18 years of experience in developing and delivering innovative solutions for the life sciences industry. Prior to joining PeC, he served as President and CEO of Datafarm, Inc., which was one of the leading solutions providers for the life sciences industry. Kumar is an accomplished senior-level executive with expertise in building and managing high-performing teams. He is an innovative thinker with solutions-oriented approach to organize and develop systems and processes in order to drive organizational stability, growth and profitability. Kumar has practical hands-on experience in many aspects of drug development processes, with domain expertise in Regulatory Electronic Submissions and Clinical Data.Steen Otto Rugaard, CEO and founder at PeC A/S states "Shy was instrumental in creating, selling, and implementing electronic submission solutions for the life sciences industry and this experience gives him the unique ability to provide exceptional leadership and create a culture of high achievement and excellent customer service, while contributing to the overall management and strategic development of our company. Plus, he is one of the best and brightest in the industry, so I am personally thrilled to have him on the PeC team.""The speed at which PeC has become one of the leading electronic submission services providers in Europe is staggering," said Shy Kumar. "I look forward at the opportunity to extend such unprecedented market leadership world-wide."

Pfizer recalls birth control pills in US because they may not work

2012-02-01T21:42:00.000-08:00

Pharmaceutical giant Pfizer on Tuesday announced a recall of some birth control pills in the United States, because they may not contain enough contraceptive to prevent pregnancy.Pfizer said the birth control pills posed no health threat to women but urged consumers affected by the recall to "begin using a non-hormonal form of contraception immediately."The recall involved 14 lots of Lo/Ovral-28 tablets and 14 lots of Norgestrel and Ethinyl Estradiol tablets, which Reuters reported involved about one million packets of birth control pills.Pfizer said an investigation found some blister packs of the oral contraceptive might contain an inexact count of inert or active ingredients in the tablets."As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy," the company said in a statement on its website.The pills were manufactured by Pfizer and marketed by Akrimax Pharmaceuticals and shipped to warehouses, clinics and retail pharmacies nationwide, the company said.

Generic pharmaceutical market set for bumper year

2012-02-01T21:40:00.000-08:00

"We anticipate that the generics industry will experience considerable growth in the coming year, after the average 11% growth we saw locally in 2011," said Paul Anley, CEO of Pharma Dynamics, whose 42% annual growth makes it the fastest-growing pharmaceutical company in SA.Anley said the expected gains in the coming year could be ascribed to the spiralling cost of healthcare and the expiry of a number of patents."There is now tremendous pressure on medical aids, and the need to cut costs is higher than ever. This need to contain costs will inevitably lead to a move towards generic alternatives from expensive originator drugs," he said.A number of products coming off patent, especially in the cardiovascular category, mean that more new generic medicines will be coming onto the market, and these more affordable treatments are likely to be an attractive option for medical aids and patients alike.Another factor favouring the growth of the generic industry was globalisation.Historically, originator companies have operated globally, while generic manufacturers were domestic in nature."We are now seeing an accelerated rate of consolidation and globalisation as companies are looking to expand their geography to attain global reach, in particular in emerging markets."The growth of the middle classes in developing countries has a direct impact on the growth of the generics market," Anley said.In middle-income settings, people often cannot afford originator medicines and generics are the obvious choice. Employed people are also much more likely to purchase affordable generics than to approach state hospitals and wait in line for medicines.According to Anley, as the market share of generics grows, originators will face decline."Originator companies facing patent expiry and hence sales reduction and a fairly significant hit to profitability are seeking to consolidate and merge."The strategy is defensive as well as aggressive, in that originators either get into existing generic companies, or buy their own in order to expand their sales base," he commented.SA was one of the world's fastest growing pharmaceutical markets, generating nearly R24 billion in pharmaceutical sales last year, and although pharmaceutical sales in SA only accounts for 1% of the global pharmaceutical market, it is growing rapidly and has moved into the top 20 markets since 2005.This explosive growth is due to changing demographics, rising incomes, modernisation of health systems and an increase in the treatment of chronic diseases, which creates a greater demand for medicines.Anley warned that continued regulatory delays were hampering the effective launch of new products in the SA market, which meant that competition was reduced and pricing was uncompetitive."Additionally, government has yet to sternly address the practice by some originators of patent ever-greening and the development of pseudo generics."Unless government intervenes, we will see this trend continuing, and impacting on the ability of generics companies to enter new products onto the market. Again, competition is reduced and prices remain inflated," he said.

Marijuana mouth spray: Will cancer pain reliever be abused?

2012-02-01T21:39:00.000-08:00

The medical marijuana drug Sativex, which could be approved in the United States in the coming years as a treatment for pain relief, has little potential for abuse, experts say.The British pharmaceutical company GW Pharmaceuticals is currently testing the drug, which is delivered as a mouth spray and called Sativex, in clinical trials. The company plans to seek U.S. Food and Drug Administration approval for the drug as a treatment for cancer pain when the trials are completed, likely sometime in 2014, a spokesperson for GW Pharmaceuticals told MyHealthNewsDaily.The active ingredients in Sativex, known as cannabinoids, are derived from the cannabis plant. It is the first marijuana-based drug to be made by extracting the compounds from the plant, rather than synthesizing them. Two other drugs, Marinol and Cesamet, based on synthetic cannabinoids, were approved by the FDA in the 1980s.Because the drug contains THC, the ingredient primarily responsible for marijuana's "high," it's possible people would use the drug for recreational rather than medical purposes."There is no doubt in my mind that there will be people that abuse it," said Dr. Jeffrey Bernstein, director of the Florida Poison Information Center at the University of Miami Miller School of Medicine.However, because the drug is delivered through ingestion, rather than smoking, it would take much longer to have an effect — at least an hour, compared with the minutes it takes to get high after smoking marijuana, said Margaret Haney, a professor of clinical neurobiology at Columbia University. This means drug users seeking a high would be less likely to abuse it. "Smoking is a really effective way to get a chemical into the brain," Haney said. The mouth spray "is a far safer administration,"she said.And Marinol and Cesamet, which are also administered orally, have a low rate of abuse. "We don’t see a lot of problems from [those]," Bernstein said.

Leading Pharmaceutical Marketing Research and Consulting Company Introduces 'Intelligent Efficiency' Program

2012-02-01T21:38:00.000-08:00

Evolution Marketing Research, the next generation pharmaceutical marketing research and consulting company, announced that it has proactively restructured in order to better take advantage of the evolving global pharmaceutical marketplace in coming years. As a keystone of this restructuring, the company has instituted a new strategy called "Intelligent Efficiency." This strategy is intended to allow the company to compete effectively in this new market environment with a streamlined organizational structure."Over the past decade, the pharmaceutical marketing research industry has known nothing but solid, often dramatic, growth. The pharmaceutical industry, however, has changed and the new definition of success in these trying economic times is stability rather than growth, in large part due to shrinking pharma marketing research budgets," said company Principal James Cummings.Evolution's founding principals look forward to a more stable market environment in the year to come which will allow for the development of new relationships in the biopharma industry. "By every definition of the term, Evolution had a stable year and is poised for success in the future," explains Daniel Slawe, Chief Operating Officer. "The restructuring of the company under our new Intelligent Efficiency program will allow us to continue to provide best-in-class service to our clients."An important part of this drive will be the development of new and innovative research methodologies and products. "Evolution is constantly in the process of creating new key products, several of which will be launching over the course of this year [2012]," said Principal Dr. James Heasley. "This is in keeping with our corporate mission of continuing to innovate and lead in an industry that is always seeking to enhance efficiencies." In 2011, the company introduced a range of innovative methodologies such as the well-received PreSIM(SM) qualitative conjoint method and its ActiveInsight(TM) custom omnibus study.Through the Intelligent Efficiency initiative, Evolution is committed to introduction of new and original methodologies geared toward aiding clients to make the most of their resources.

Drug scandal a conspiracy: Chairman Efroze Chemicals

2012-02-01T21:37:00.000-08:00

The chairman of the pharmaceutical company (Efroze Chemicals) which manufactures the medicine suspected to be behind the death of cardiac patients in Lahore has said the scandal is a conspiracy against them.

The chairman adds that the chemical in question had been stolen from their store in September.

Meanwhile the pharmaceutical company has been sealed and according to Chief Minister Punjab Shahbaz Shairf, the names of the owners have been placed on the Exit Control List.

Tests conducted by a laboratory in London proved that the substandard medicine was behind the deaths as it contained anti-malarial chemical 14 times more than required.

Takeda Cuts Outlook, While Astellas Get Boost

2012-02-01T21:36:00.000-08:00

Takeda Pharmaceutical Co. lowered its earnings outlook as it deals with streamlining costs after last year's $13.7 billion acquisition of Swiss drug maker Nycomed, while rival Astellas Pharma Inc. appears headed toward a new growth phase.Although initial costs will likely weigh heavily on Takeda's earnings, Japan's biggest drug maker by sales is aiming to reap the benefits of the largest acquisition in its history as Japanese drug makers seek overseas growth to compensate for the lackluster home market and a wave of patent expirations.

Pfizer wins battle over Viagra trademark issue

2012-01-30T20:41:00.000-08:00

A European Court has ruled that the name Viaguara cannot be registered as an EU trademark for energy and alcoholic drinks because it is too similar to Pfizer’s erectile dysfunction drug Viagra.

The EU’s General Court ruled that the similarity allowed Viaguara ‘to take unfair advantage of the distinctive character or repute of the trademark Viagra’.

Warsaw-based Viaguara SA applied for an EU trademark in 2005, but was refused. The court has now rejected the company’s appeal. The General Court ruling itself can only be appealed on points of law.

Also because of the medical implications, the court said it would be dangerous to let any confusion exist.

‘Even if the non-alcoholic drinks concerned do not actually have the same benefits as a drug to treat erectile dysfunction, the consumer will be inclined to buy them thinking that he will find similar qualities, such as an increase in libido,’ the court said.

The court concluded that Viaguara SA, by using a mark similar to Viagra was ‘attempting to ride on the coat-tails of that mark in order to benefit from its power of attraction, its reputation and its prestige’. It was also attempting to exploit, ‘without paying any financial compensation’, the marketing effort expended by Pfizer to promote its own products.

In order to avoid potential confusion among pharmaceutical brands, in a separate announcement, Thomson CompuMark, a global leader in trademark searching and brand protection solutions, has launched Global Pharmaceutical Search, a new service providing targeted, global trademark intelligence in a single online report.

Search coverage includes the firm’s proprietary, trademark office records, web and domain name coverage, and US and European regulatory and industry-specific sources, including pharmaceutical names in use. Brand owners can select the registers that match their product strategy, including the US, UK, Spain, France, Germany, Switzerland, Italy, Benelux, and Canada.

FDA Approves BYDUREON(TM) -- The First and Only Once-Weekly Treatment for Type 2 Diabetes

2012-01-27T18:32:00.000-08:00

Amylin Pharmaceuticals, Inc. AMLN +16.15% and Alkermes plc ALKS +4.61% today announced that the U.S. Food and Drug Administration (FDA) has approved BYDUREON(TM) (exenatide extended-release for injectable suspension) - the first once-weekly treatment for type 2 diabetes. BYDUREON is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings. BYDUREON will be available in pharmacies nationwide in February.To view the multimedia assets associated with this release, please visit: http://www.multivu.com/mnr/53897-amylin-alkermes-plc-bydureon-fda-approved-treatment-type-2-diabetes"With BYDUREON, U.S. physicians and patients can now choose a therapy that offers continuous blood sugar control in just one dose per week," said John Buse, M.D., Ph.D., professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control."The approval of BYDUREON (pronounced by-DUR-ee-on) was based on safety and efficacy data from the DURATION clinical trial program, in which treatment with BYDUREON resulted in improvements in glycemic control with just one dose per week. The approval was also based on clinical experience with BYETTA® (exenatide) injection, a twice-daily form of exenatide that has been available in the U.S. since June 2005 and is used in nearly 80 countries worldwide. BYDUREON uses Alkermes' proprietary technology for long-acting medications to provide a controlled release of exenatide."As the first and only once-weekly diabetes treatment, BYDUREON represents an important milestone in Amylin's promise to bring to market innovative therapies to help improve the lives of people with type 2 diabetes," said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. "BYDUREON builds upon the proven benefits of BYETTA, offering significant improvements in glycemic control in a single weekly dose."In the DURATION-5 head-to-head clinical study, after 24 weeks of treatment, patients taking once-weekly BYDUREON experienced a statistically superior reduction in A1C of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for patients taking BYETTA. A1C is a measure of average blood sugar over three months. Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking BYDUREON and 3.0 pounds for patients taking BYETTA (weight loss was a secondary endpoint).The most frequently reported adverse event in both groups was nausea, reported less frequently by BYDUREON users (14 percent) than by BYETTA users (35 percent). Other common treatment-emergent adverse events in the BYDUREON group included diarrhea, upper respiratory tract infection and injection site nodules. There were no major hypoglycemic events.BYDUREON has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of BYDUREON outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma. As part of the REMS, Amylin has established a communication plan for healthcare professionals to help minimize these risks. In addition, Amylin will fulfill a number of post-marketing requirements to further assess the impact of BYDUREON on medullary thyroid cancer and cardiovascular disease. More information will be available at www.BYDUREON.com .BYDUREON is provided in a straightforward single-dose tray so that patients can self-administer the once-weekly subcutaneous injection. In the DURATION clinical studies, the delivery system was well accepted by patients and physicians.Amylin to Host Investor Conference Call Amylin will host a conference call led by Mr. Bradbury to discuss the approval of BYDUREON today at 4:30 p.m. EST. A slide presentation accompanying the conference call will be made available through the "Investors" section of Amylin's corporate website at www.amylin.com .The call will be webcast live through the "Investors" section of Amylin's corporate website, and a recording will be made available following the close of the call. To access the webcast, please log on to www.amylin.com approximately 15 minutes prior to the call to register, download and install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by calling (800) 857-5738 (U.S./Canada) or (415) 228-4970 (international), conference access code #7253303. A replay of the call will also be available by phone beginning approximately two hours after the close of the call and can be accessed at (800) 964-3620 (U.S./Canada) or (203) 369-3425 (international).About BYDUREON(TM) (exenatide extended-release for injectable suspension) BYDUREON, previously known as exenatide once weekly, is the first and only once-weekly medicine to be approved by the FDA for the treatment of type 2 diabetes. BYDUREON works with the body to help make its own insulin when needed, providing continuous glycemic control with just one dose per week. Each dose of BYDUREON is made up of biodegradable microspheres that provide a controlled release of exenatide throughout the week.BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise. BYDUREON is not recommended as the first medication to treat diabetes.BYDUREON is a long-acting form of the medication in BYETTA® (exenatide) injection so both drugs should not be used together. BYDUREON is not insulin and should not be taken instead of insulin. BYDUREON is not for people with type 1 diabetes or people with diabetic ketoacidosis. BYDUREON is not recommended for use in children. It is not known if BYDUREON is safe and effective in people with a history of pancreatitis or severe kidney problems. See important safety information below. Additional information about BYDUREON will be available at www.BYDUREON.com .Important Safety Information for BYDUREON(TM) (exenatide extended-release for injectable suspension)In animal studies, BYDUREON caused rats to develop tumors of the thyroid gland. Some tumors were cancers. It is not known if BYDUREON causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. BYDUREON should not be used if there is a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2.Based on post-marketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Patients should be observed for signs and symptoms of pancreatitis after initiation of BYDUREON.The risk of getting low blood sugar is higher if BYDUREON is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of sulfonylurea may need to be lowered while BYDUREON is used. BYDUREON should not be used in people who have or had severe kidney problems and may cause or worsen problems with kidney function, including kidney failure. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Antibodies may develop with use of BYDUREON, which may lead to worsening or failure to achieve adequate glycemic control. Severe allergic reactions can happen with BYDUREON. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYDUREON or any other antidiabetic drug.The most common side effects with BYDUREON include nausea, diarrhea, headache, vomiting, constipation, itching at injection site, a small bump (nodule) at the injection site, and indigestion. Nausea most commonly happens when first starting BYDUREON, but may become less over time.These are not all the side effects from use of BYDUREON. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.For additional important safety information about BYDUREON, please see the full Prescribing Information ( www.BYDUREON.com/pi ) and Medication Guide ( www.BYDUREON.com/mg ), to be posted shortly.About BYETTA® (exenatide) injection BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone GLP-1. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. It can also be used with metformin, a sulfonylurea, a thiazolidinedione or Lantus® (insulin glargine), which is a long-acting insulin.BYETTA is not insulin and should not be taken instead of insulin. BYETTA should not be taken with short- and/or rapid-acting insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis. BYETTA has not been studied in patients with a history of pancreatitis. Other antidiabetic therapies should be considered for these patients.BYETTA provides sustained A1C control with potential weight loss (BYETTA is not a weight-loss product). BYETTA was approved in the U.S. in April 2005 and in Europe in November 2006 and has been used by more than 1.8 million patients since its introduction. See important safety information below. Additional information about BYETTA is available at www.BYETTA.com .Important Safety Information for BYETTA® (exenatide) injectionBased on post-marketing data, BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Patients should be observed for signs and symptoms of pancreatitis after initiation or dose escalation of BYETTA.The risk of getting low blood sugar is higher if BYETTA is taken with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of sulfonylurea or insulin may need to be lowered while BYETTA is used. BYETTA should not be used in people who have severe kidney problems and may cause or worsen problems with kidney function, including kidney failure. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Antibodies may develop with use of BYETTA. Patients who develop high titers to exenatide could have worsening or failure to achieve adequate glycemic control. Severe allergic reactions can happen with BYETTA. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.The most common side effects with BYETTA include nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, acid stomach, constipation and weakness. Nausea most commonly happens when first starting BYETTA, but may become less over time.These are not all the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.For additional important safety information about BYETTA, please see the full Prescribing Information ( www.BYETTA.com/pi ) and Medication Guide ( www.BYETTA.com/mg ).About Diabetes Diabetes affects nearly 26 million people in the U.S. and an estimated 347 million adults worldwide.[i],[ii] Approximately 90-95 percent of those affected have type 2 diabetes. In the U.S., diabetes costs more than $174 billion per year in direct and indirect medical expenses.[iii]According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.[iv] In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.[v] Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.[vi],[vii]About Amylin Pharmaceuticals Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin is committed to delivering novel therapies that transform the way diabetes, obesity and related metabolic disorders are treated. Amylin is headquartered in San Diego, Calif. and has a commercial manufacturing facility in Ohio. More information about Amylin Pharmaceuticals is available at www.amylin.com .About Alkermes plc Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Mass. and manufacturing facilities in Athlone, Ireland; Gainesville, Ga.; and Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com .Forward-Looking Statement This press release contains forward-looking statements about Amylin and Alkermes. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that BYETTA and/or BYDUREON and the revenues generated from these products may be affected by competition; unexpected new data; safety and technical issues; clinical trials not being completed in a timely manner, not confirming previous results, not being predictive of real-world use or not achieving the intended clinical endpoints; label expansion requests or New Drug Application filings not being submitted and/or accepted in a timely manner or receiving regulatory approval; the commercial launch of BYDUREON in the U.S. being delayed or not successful; or manufacturing and supply issues. The potential for BYETTA and/or BYDUREON may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the development and commercialization of pharmaceutical products. These and additional risks and uncertainties are described more fully in Amylin's and Alkermes' SEC filings including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin and Alkermes undertake no duty to update these forward-looking statements.BYETTA is a registered trademark and BYDUREON is a trademark of Amylin Pharmaceuticals, Inc. All other marks are the marks of their respective owners.

Seminar is perfect tonic for Watford's pharmaceutical firms

2012-01-27T18:31:00.000-08:00

A lunchtime seminar entitled The Future of Pharma by Professor Brian D Smith was hosted by solicitors Matthew Arnold and Baldwin LLP in conjunction with Watford Chamber of Commerce.Professor Smith, a recognised leader in the pharmaceutical field, explored the rapid changes and challenges facing the pharma industry.He discussed how companies have to recognise that change is needed and what action is required if they are to remain successful.He said: “Evolution is what is happening to the pharmaceutical industry. It is not a metaphor, it is a fact.”He went on to say that for the industry to survive, pharmaceutical firms needed to keep adapting.He argued that one way to do this was to have some understanding of what to expect in the future and he provided some of his own predictions on what the future would hold.Pharmaceutical companies form a considerable hub in the Watford area and more than 30 companies attended the event, including large firms such as Pfizer and AstraZeneca. The audience totalled more than 100 people.Paul Gershlick, head of pharmaceuticals and life sciences at MAB, said: “We were delighted Professor Smith was able to come and that so many of the local pharma businesses were in attendance.“His talk was engaging and provided a real insight to the future of the industry. There is now a substantial hub in the Watford area which continues to provide growth and development both to the local area and the pharmaceutical industry.”Sanjay Purohit, from Watford and West Herts Chamber of Commerce added: “We are delighted to have been involved in delivering this very successful, sector focused event. It is one of a series we have planned for 2012, to enable growth, business support and the economic vibrancy of Watford, in challenging times.“The event also supports the Watford Health Campus Project, ensuring pharmaceutical and life science companies that attended are aware of this substantial opportunity to them.”

GenVec Extends Research Collaboration with Global Pharmaceutical Company

2012-01-27T18:30:00.001-08:00

GenVec, Inc. GNVC +8.30% , a biopharmaceutical company using differentiated, proprietary technologies to create superior therapeutics and vaccines, today announced that it has extended its Research Collaboration and License Agreement with Novartis NVS +0.10% . Under the extension, Novartis will fund research at GenVec through January 2013 to support its hearing loss and balance disorders program."GenVec has worked closely with Novartis for the past two years to move this program forward and we remain committed to being a value added partner," noted Douglas E. Brough, Ph.D., GenVec's Vice President of Research. "This extension will allow GenVec to continue supporting this important effort."

Royal Pharmaceuticals to Build a Branded Division

2012-01-27T18:29:00.000-08:00

Royal's branded division will augment Granard’s trade and distribution services as well as their generic products group. Royal Pharmaceuticals is currently seeking branded pharmaceuticals to in-license or purchase.“Having presence in both pharmaceutical services and generics, the next logical step in diversifying our portfolio is marketing branded products under Royal Pharmaceuticals,” said Armand Crupi, Executive Vice President.A privately held company for over 15 years, Granard provides trade, sales, and marketing representation to both brand and generic pharmaceutical companies. Granard also provides manufacturers the opportunity to utilize the brand and generic relationships built over time with chains, wholesalers, distributors and mail order customers. Clients achieve rapid market penetration by Granard leveraging established relationships with more than 80 national points of distribution, including pharmaceutical wholesalers, generic distributors, retail chains and mail order pharmacies.

Pharmaceutical giant recalls painkiller, Excedrin in SA

2012-01-27T18:28:00.001-08:00

In a newspaper advertisement announcing the "URGENT MEDICINE RECALL" of the tablets, the company indicated that it had acted in collaboration with the Medicines Control Council of South Africa."This recall is a precautionary measure following consumer complaints of chipped and broken tablets and inconsistent bottle packaging line clearance practices at our Lincoln, Nebraska facility, which could result in bottles containing foreign tablets, caplets or capsules," the company explained.This is a Class I, Type A recall of the product which contains paracetamol, aspirin and caffeine.Class I is described as "defective-dangerous-potentially life-threatening medicines that predictably or probably could result in serious health risk-adverse events or even death."The company however indicated that the recall was not based on adverse events related to the recalled product, but out of "an abundance of caution".The product is sold in almost 40 countries.In the United States Novartis announced a voluntary recall on January 8. According to Novartis Consumer Health spokesman Senka Hadzimuratovic, the company then identified, reviewed and assessed lots of Excedrin manufactured at the Lincoln facility that were distributed elsewhere.Novartis Consumer Health is not aware of adverse events in South Africa reported with the issues leading to the recall.The local authorities were contacted on January 11 and the recall was issued on January 20.The products should be returned to the pharmacy or store where it was purchased and only tablets in the original manufacturer's bottle will be credited.

Teva Pharmaceutical Industries Ltd (TEVA) Shares Given New $48.00 Price Target by Goldman Sachs (GS) Analysts

2012-01-26T23:33:00.000-08:00

Research analysts at Goldman Sachs (NYSE: GS) increased their price target on shares of Teva Pharmaceutical Industries Ltd (NASDAQ: TEVA) to $48.00 in a report issued on Thursday.Separately, analysts at Jefferies Group (NYSE: JEF) reiterated a “hold” rating on shares of Teva Pharmaceutical Industries Ltd in a research note to investors on Friday, December 23rd. They now have a $43.00 price target on the stock. Analysts at Piper Jaffray (NYSE: PJC) reiterated a “neutral” rating on shares of Teva Pharmaceutical Industries Ltd in a research note to investors on Thursday, December 22nd. They now have a $45.00 price target on the stock. Also, analysts at Needham & Company reiterated a “buy” rating on shares of Teva Pharmaceutical Industries Ltd in a research note to investors on Thursday, December 22nd.Teva Pharmaceutical Industries Limited (Teva) is a global pharmaceutical and drug company. It develops, produces and markets generic drugs in all treatment categories. The Company has a pharmaceutical business, whose principal products include Copaxone and Azilect. Teva’s active pharmaceutical ingredient (API) business provides vertical integration to Teva’s own pharmaceutical production. The Company’s global operations are conducted from North and Latin America to Europe and Asia. As December 31, 2010, it had direct operations in approximately 60 countries, including 40 finished dosage pharmaceutical manufacturing sites in 19 countries, 28 pharmaceutical research and development (R&D) centers and 21 API manufacturing sites. On October 14, 2011, it acquired Cephalon, Inc.Teva Pharmaceutical Industries Ltd traded down 1.39% on Thursday, hitting $45.45. Teva Pharmaceutical Industries Ltd has a 1-year low of $35.00 and a 1-year high of $56.34. The stock has a 50-day moving average of $42. and a 200-day moving average of $40.99. The company has a market cap of $40.223 billion and a price-to-earnings ratio of 13.72.

Valeant Pharmaceuticals (VRX) Downgraded by Piper Jaffray (PJC)

2012-01-26T23:32:00.000-08:00

Valeant Pharmaceuticals (NYSE: VRX) was downgraded by investment analysts at Piper Jaffray (NYSE: PJC) from an “overweight” rating to a “neutral” rating in a note issued to investors on Thursday.Separately, analysts at Morgan Stanley (NYSE: MS) upgraded shares of Valeant Pharmaceuticals from an “equal weight” rating to an “overweight” rating in a research note to investors on Tuesday, January 10th. Analysts at Jefferies Group (NYSE: JEF) reiterated a “buy” rating on shares of Valeant Pharmaceuticals in a research note to investors on Monday, January 9th. Also, analysts at Wells Fargo & Co. (NYSE: WFC) reiterated a “market perform” rating on shares of Valeant Pharmaceuticals in a research note to investors on Thursday, December 22nd.Valeant Pharmaceuticals International Inc., formerly Biovail Corporation, is a specialty pharmaceutical company. The Company focuses on developing and commercializing products in specialty central nervous system (CNS) disorders. As of December 31, 2009, the Company’s products within its development pipeline included Staccato loxapine, Pimavanserin, BVF-018, Fipamezole and GDNF. In May 2009, the Company acquired the United States commercialization rights to Wellbutrin XL from The GlaxoSmithKline Group of Companies (GSK). In June 2009, it acquired the worldwide development and commercialization rights to the entire portfolio of tetrabenazine products, including Xenazine and Nitoman, held by Cambridge Laboratories (Ireland) Ltd. (Cambridge).Valeant Pharmaceuticals opened at 50.72 on Thursday. Valeant Pharmaceuticals has a 52-week low of $32.05 and a 52-week high of $57.24. The stock has a 50-day moving average of $47.52 and a 200-day moving average of $43.95. The company has a market cap of $15.617 billion and a price-to-earnings ratio of 216.75.

Watson Confirms Court Stays Preliminary Injunction

2012-01-26T23:31:00.000-08:00

Watson Pharmaceuticals, Inc. WPI +0.00% , today confirmed that the United States Court of Appeals for the Federal Circuit has granted Watson and Amphastar Pharmaceuticals, Inc's request for a stay of the preliminary injunction preventing the companies from marketing or selling Amphastar's Enoxaparin Sodium Injection, a generic equivalent to Sanofi-aventis' LOVENOX®. The Federal Circuit's Order does not represent a final decision with respect to the merits of the pending appeal or the underlying litigation. Amphastar and Watson plan to launch their Enoxaparin Sodium Injection product immediately.Enoxaparin is a low molecular weight heparin indicated in the prophylaxis and treatment of deep vein thrombosis and prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction.On September 19, 2011, Amphastar received U.S. Food and Drug Administration ("FDA") approval of its Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection in the 30mg/mL, 40mg/mL, 60mg/mL, 80mg/mL,100mg/mL, 120mg/mL, 150mg/mL and 300mg/mL strengths. Watson has the exclusive right to distribute Amphastar's Enoxaparin in the U.S. retail pharmacy channel.

Auxilium Pharmaceuticals, Inc. Announces First Patients Dosed in XIAFLEX

2012-01-26T23:28:00.000-08:00

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the first cohort of patients has been dosed in its phase Ib trial of XIAFLEX® (collagenase clostridium histolyticum) for the treatment of edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite. Cellulite has been reported to occur in 85-98% of post-pubertal females and rarely in men. The condition is prevalent in women of all races. (1,3)
Cellulite is described as a localized metabolic disorder of tissue under the skin, which can involve the loss of elasticity or shrinking of collagen cords, called septae, that attach the skin to lower layers of muscle. When fat in cellulite prone areas swells and expands, the septae tether the skin, which causes surface dimpling characteristic of cellulite. XIAFLEX treatment is intended to target and lyse, or break, those collagen tethers with the goal of releasing the skin dimpling and potentially resulting in smoothing of the skin. "For many women, cellulite can be a source of considerable embarrassment or self-consciousness," said Dr. James Tursi, Chief Medical Officer at Auxilium. "Current treatments of cellulite with creams, light-based procedures or liposuction provide limited or no effectiveness. The clinical development of XIAFLEX, if successful, could lead to the first FDA-approved, office-based medical treatment option that is supported by scientific results."The phase Ib study is a single site, open-label dose-escalation study that is targeted to enroll 63 women between 21 and 60 years of age. The objectives of the study are to assess the safety, effectiveness, and pharmacokinetics of XIAFLEX for the treatment of EFP. Topline results are expected in the second half of 2012."Dosing in the cellulite clinical trial represents another important development milestone for Auxilium as we advance a fourth potential indication of XIAFLEX into the clinic, further diversifying XIAFLEX's growing pipeline," explained Adrian Adams, Chief Executive Officer and President of Auxilium. "We believe cellulite represents a significantly undertreated condition and that innovative approaches such as XIAFLEX may one day be a viable solution for treatment."
Read more here: http://www.sacbee.com/2012/01/26/4216589/auxilium-pharmaceuticals-inc-announces.html#storylink=cpy

Read more here: http://www.sacbee.com/2012/01/26/4216589/auxilium-pharmaceuticals-inc-announces.html#storylink=cpy

Weekly Investment Analysts’ Ratings Changes for Watson Pharmaceuticals Incorporated (WPI

2012-01-26T23:27:00.000-08:00

A number of stock research firms have changed their ratings and price targets for Watson Pharmaceuticals Incorporated (NYSE: WPI) during the last seven days:Watson Pharmaceuticals Incorporated had its “overweight” rating re-affirmed by analysts at Piper Jaffray. They now have a $78.00 price target on the stock.Watson Pharmaceuticals Incorporated had its “buy” rating re-affirmed by analysts at Canaccord Genuity.Watson Pharmaceuticals Incorporated had its price target lowered by analysts at Piper Jaffray from $78.00 to $73.00.Watson Pharmaceuticals Incorporated had its “buy” rating re-affirmed by analysts at UBS AG.Watson Pharmaceuticals Incorporated had its “hold” rating re-affirmed by analysts at Needham & Company.Watson Pharmaceuticals Incorporated ‘s EPS estimates were cut by analysts at Credit Suisse. They now have an “outperform” rating and a $77.00 price target on the stock.Watson Pharmaceuticals Incorporated had its “conviction buy” rating re-affirmed by analysts at Goldman Sachs.Watson Pharmaceuticals Incorporated was downgraded by analysts at Citigroup from a “buy” rating to a “neutral” rating.Watson Pharmaceuticals Incorporated was downgraded by analysts at Cowen from an “outperform” rating to a “neutral” rating.Watson Pharmaceuticals Incorporated was upgraded by analysts at Morgan Stanley from an “equal weight” rating to an “overweight” rating. They now have a $65.00 price target on the stock.Watson Pharmaceuticals Incorporated had its price target lowered by analysts at Collins Stewart from $75.00 to $60.00. They now have a “neutral” rating on the stock.Watson Pharmaceuticals Incorporated was upgraded by analysts at Bank of America to a “buy” rating.Watson Pharmaceuticals Incorporated was upgraded by analysts at RBC Capital from a “sector perform” rating to an “outperform” rating. They now have a $66.00 price target on the stock, down previously from $67.00.Watson Pharmaceuticals Incorporated had its price target lowered by analysts at Jefferies Group to $60.00.

Rexahn Pharmaceuticals Publishes New Preclinical Data for Quinoxalinyl-Piperazine Compounds

2012-01-26T23:26:00.000-08:00

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing best in class oncology and CNS therapeutics, today announced the publication of preclinical results for RX-5902 inBioorganic & Medicinal Chemistry [20:1303-1309, 2012] titled, “Synthesis, anticancer activity and pharmacokinetic analysis of 1-[(substituted 2-alkoxyquinoxalin-3-yl)aminocarbonyl]-4-(hetero)arylpiperazine derivatives.”In the study, various new quinoxalinyl-piperazine derivatives were shown to have excellent anti-proliferative activity against different human cancer cells, and some selected compounds showed excellent pharmacokinetic properties in rats. In particular, RX-5902 exhibited desirable pharmacokinetic properties – such as in oral bioavailability, half-life, and plasma concentration - supporting its continued development as an orally deliverable potent anti-cancer drug.“In this second published study of RX-5902, we further establish that it is a potent anti-cancer compound with the optimal pharmacokinetic properties for oral administration,” said Rick Soni, President of Rexahn. “For RX-5902, as a first-in-class RNA helicase inhibitor, we plan to file an Investigational New Drug application in the second quarter of this year.”
In November 2010, Rexahn published additional pre-clinical data in Bioorganic & Medicinal Chemistry [18:7966-7974, 2010], demonstrating that RX-5902, significantly inhibited the growth of human cancer cells, including paclitaxel (Taxol®) resistant HCT-15 human colorectal cancer cells, and showed potential use in combination therapy with known anticancer drugs such as paclitaxel, doxorubicin, gemcitabine, 5-FU and cisplatin.
Read more here: http://www.sunherald.com/2012/01/25/3709006/rexahn-pharmaceuticals-publishes.html#storylink=cpy

Spectrum Pharmaceuticals to Acquire Worldwide Rights to Market ZEVALIN(R)

2012-01-26T23:25:00.001-08:00

Irrevocable License From Bayer Healthcare Leverages Spectrum's Existing Clinical, Regulatory and Marketing Investments;--Spectrum Will Continue To Advance ZEVALIN's Clinical Development Program And Will Now Be Better Positioned To Grow ZEVALIN Sales Globally In The Long-Term.Spectrum Pharmaceuticals (nasdaqgs:SPPI) announced that it has entered into an agreement to acquire licensing rights to market ZEVALIN (ibritumomab tiuxetan) injection for intravenous use outside of the United States of America from Bayer Healthcare. ZEVALIN is currently approved in more than 40 countries outside the U.S. for the treatment of follicular B-cell non-Hodgkin's lymphoma, including countries in Europe, Latin America and Asia. Under the agreement, Spectrum will have all rights related to marketing, sales, and patents, and access to existing inventory of ZEVALIN from Bayer. Spectrum will utilize a combination of company resources and partnerships to support the product outside the U.S."We are excited to expand our commercial footprint globally with an approved, state-of-the-art drug that we know very well," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Our experience in the U.S. marketplace and the impressive and broadening clinical outcome data from ZEVALIN, as presented at major international scientific conferences over the past two years, has increased our confidence in the long-term potential of ZEVALIN. With the licensing of ex-U.S., worldwide rights to ZEVALIN, we will be able to further leverage our existing clinical, regulatory and marketing investments. Working closely with European investigators who have spearheaded exciting new data with ZEVALIN in recent years, Spectrum will continue to advance its clinical development program and will now be better positioned to grow ZEVALIN sales globally in the long-term. Our access to the worldwide market will help patients with follicular lymphoma who can benefit from ZEVALIN.""The global market for ZEVALIN is several times larger than the US, with more than 350,000 cases of non-Hodgkin's lymphoma diagnosed every year. Since acquiring the U.S. rights to ZEVALIN in 2008, we have successfully reversed the declining sales trajectory and nearly tripled 2008 sales. We hope to achieve similar milestones outside the U.S. with our focused sales and marketing efforts. This licensing transaction demonstrates our commitment to being focused on our strategy of bringing novel cancer treatments to patients while at the same time delivering value to our shareholders," concluded Dr. Shrotriya.The closing of the agreement is subject to customary closing conditions. The Merchant Banking Group of Burrill & Company acted as advisor to Spectrum Pharmaceuticals in this transaction.

Watson Pharmaceuticals Incorporated (WPI) Upgraded by RBC Capital (RY

2012-01-26T23:24:00.001-08:00

Watson Pharmaceuticals Incorporated (NYSE: WPI) was upgraded by investment analysts at RBC Capital (NYSE: RY) from a “sector perform” rating to an “outperform” rating in a note issued to investors on Wednesday.Separately, analysts at Bank of America (NYSE: BAC) upgraded shares of Watson Pharmaceuticals Incorporated to a “buy” rating in a research note to investors on Wednesday. Analysts at Collins Stewart cut their price target on shares of Watson Pharmaceuticals Incorporated from $75.00 to $60.00 in a research note to investors on Wednesday. They now have a “neutral” rating on the stock. Also, analysts at Morgan Stanley (NYSE: MS) upgraded shares of Watson Pharmaceuticals Incorporated from an “equal weight” rating to an “overweight” rating in a research note to investors on Wednesday. They now have a $65.00 price target on the stock.Watson Pharmaceuticals, Inc. (Watson) is an integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic and brand pharmaceutical products. It operates in three segments: Global Generics, Global Brands and Distribution. It operates in international markets, including Western Europe, Canada, Australasia, Asia, South America and South Africa with its commercial market being the United States of America. As of December 31, 2010, it marketed approximately 160 generic pharmaceutical product families and approximately 30 brand pharmaceutical product families in the United States, and distributed approximately 8,500 stock-keeping units (SKUs) through its Distribution Division. In January 2010, the Company acquired 64% of Eden Biopharm Group Limited (Eden). In May 2011, it acquired Specifar Pharmaceuticals S.A.Watson Pharmaceuticals Incorporated traded up 2.79% on Wednesday, hitting $57.45. Watson Pharmaceuticals Incorporated has a 52-week low of $53.46 and a 52-week high of $73.35. The stock has a 50-day moving average of $60.82 and a 200-day moving average of $65.24. The company has a market cap of $7.305 billion and a price-to-earnings ratio of 38.44.

Lando & Anastasi, LLP Expands Chemical/Materials, Biotechnology/Pharmaceutical, and Electrical/Computer Patent Teams

2012-01-26T23:22:00.000-08:00

Lando and Anastasi, LLP (L&A) today announced that Juliet DeFrancisco, Caroline Roush, Sylvia Georges, Angela Grant, and Tsoline Mikaelian have joined the firm.The Cambridge-based intellectual property law firm, one of the largest IP firms in New England, has continued its rapid growth. The L&A chemical and materials, biotechnology and pharmaceutical, and electrical and computer science practice areas had strong years in 2011 and look forward to even more growth in 2012. The firm's commitment to high quality counsel, responsive service, and value make it sought after by large companies and start-ups alike."We are pleased to add new talent to the firm, and fortunate to have such accomplished young people join L&A," commented Peter Lando, a Partner at L&A.Juliet DeFrancisco is an Associate at L&A. She will focus her practice on patent and trademark counseling and prosecution in various chemical and materials-related technologies, particularly in the area of water and wastewater treatment, scientific instruments, electrical devices, and solar technologies.Juliet graduated from Boston College Law School, where she was the editor of the Boston College Intellectual Property and Technology Forum. She received a B.S. in Chemical Engineering and Economics from Columbia University. While in law school Juliet worked at IBM's Collaborative Solutions Legal Group.Caroline Roush is a Technology Specialist at L&A, and focuses her practice on patent prosecution in the areas of chemical and materials science. Prior to joining L&A, she was a Technology Specialist at Banner & Witcoff in Boston.Caroline is registered to practice before the United States Patent and Trademark Office. She received an M.S. in Chemical Engineering from Michigan State University, a B.A. in Chemistry from Albion College, and currently is in her final year at Suffolk University Law School. Prior to entering intellectual property law, Caroline worked in a variety of industries involving semiconductor processing, optical and electrical measurement devices, environmental remediation, and nanocrystal display technologies."The addition of Juliet and Caroline to the chemical and materials group is a terrific solution to our need for expanded bandwidth due to the growth in the practice over the past year," added Lando.Sylvia Georges is a Technology Specialist at L&A, and focuses her practice on patent prosecution, diligence and counseling in biotechnology and pharmaceuticals. Prior to joining L&A, she was a Technology Specialist at Fish & Richardson in Boston.Sylvia is registered to practice before the United States Patent and Trademark Office. She received a Ph.D. in Chemistry from Brown University; she completed her post-doctoral fellowship at Harvard Institute of Chemistry and Cell Biology. Sylvia received her B.A. in Chemistry and Spanish from Wellesley College. Prior to entering intellectual property law, Sylvia was a Senior Scientist at Infinity Pharmaceuticals. Sylvia is the author of several scientific research articles and is a named inventor on twelve U.S. patents.Angela Grant is a Technology Specialist at L&A, and focuses her practice on patent prosecution, diligence and counseling in the biomedical and biotechnology fields, including microbiology, immunology, biochemistry, and molecular and cell biology.Angela received her Ph.D. and M.Phil. in Microbiology and Immunology from The George Washington University. Angela received a B.Sc. in Biology from Randolph Macon Woman's College. She has authored several scientific research articles published in leading journals, and has received numerous research awards, including postdoctoral fellowship awards from the American Heart Association and the National Science Foundation."The diligence and hard work we have already seen from Sylvia and Angela since joining the firm are impressive," remarked Cathy McCarty, a Partner in L&A's life sciences group. "We are thrilled that they have so quickly become integral members of our client teams."Tsoline Mikaelian is a Technology Specialist at L&A. She will focus her practice on patent prosecution in various electrical and computer technologies, particularly in the areas of computer systems and electronics, medical devices and consumer products.Tsoline received her Ph.D. in Aerospace Systems Engineering from the Massachusetts Institute of Technology; she completed her post-doctoral fellowship at the MIT Computer Science and Artificial Intelligence Lab and the Center for Technology, Policy, and Industrial Development. Tsoline also received an S.M. in Aeronautics and Astronautics from the Massachusetts Institute of Technology., and a B.Sc. in Physics and Astronomy from York University. She has authored several scientific research articles published in leading journals, and has received research sponsorship from NASA, JPL, DARPA, DoD, the Singapore Defense Science and Technology Agency and DSO National Laboratories.Sarah Gates, a partner in L&A's electrical and computer science practice noted, "Tsoline is a great addition to the EECS group, and we are excited that she has joined us at L&A. She has already immersed herself in our clients' core technologies, and shows a great ability to work in a variety of areas."

JK has vast potential in pharmaceutical sector: Slathia

2012-01-26T23:21:00.000-08:00

The Jammu and Kashmir government today said the state has vast potential in pharmaceutical sector and pharma colleges will be opened to meet trained man power requirements of the industry. "JK has vast potential for promotion of pharmaceutical industries which needs to be exploited optimally. Pharma colleges will be opened to meet the trained man power requirements of the sector," Industries and Commerce Minister S S Slathia said at a meeting convened here to device future strategies for promoting pharmaceutical industries in JK. While assuring full support for promotion of both pharma and aroma industries in the state, he said a Rs 100 crore project has been launched to upgrade basic infrastructure in the industrial estates of Bari Brahmana, Gangyal and Samba.

Inovio Pharmaceuticals and Keryx Biopharmaceuticals Benefit From Strengthening Biotech Sector

2012-01-26T23:20:00.000-08:00

The biotechnology industry has performed well in the early stages of 2012. The iShares NASDAQ Biotechnology Index is presently up nearly eight percent month-on-month as the industry continues to recover nicely from the global economic crisis. According to a recent report from Global Industry Analysts, Inc. (GIA) the improving economic conditions have led to an increase in funding for the biotechnology industry

Watson Pharmaceuticals Incorporated (WPI) Share Price Target Lowered to $60.00 by Collins Stewart Analysts

2012-01-26T23:19:00.000-08:00

Analysts at Collins Stewart cut their price target on shares ofWatson Pharmaceuticals Incorporated (NYSE: WPI) from $75.00 to $60.00 in a research report issued to clients and investors on Wednesday. They currently have a “neutral” rating on the company’s shares.Separately, analysts at Morgan Stanley (NYSE: MS) upgraded shares of Watson Pharmaceuticals Incorporated to an “overweight” rating in a research note to investors on Wednesday. Analysts at Cowen downgraded shares of Watson Pharmaceuticals Incorporated from an “outperform” rating to a “neutral” rating in a research note to investors on Tuesday. Also, analysts at Citigroup (NYSE: C) downgraded shares of Watson Pharmaceuticals Incorporated from a “buy” rating to a “neutral” rating in a research note to investors on Tuesday.Watson Pharmaceuticals, Inc. (Watson) is an integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic and brand pharmaceutical products. It operates in three segments: Global Generics, Global Brands and Distribution. It operates in international markets, including Western Europe, Canada, Australasia, Asia, South America and South Africa with its commercial market being the United States of America. As of December 31, 2010, it marketed approximately 160 generic pharmaceutical product families and approximately 30 brand pharmaceutical product families in the United States, and distributed approximately 8,500 stock-keeping units (SKUs) through its Distribution Division. In January 2010, the Company acquired 64% of Eden Biopharm Group Limited (Eden). In May 2011, it acquired Specifar Pharmaceuticals S.A.Watson Pharmaceuticals Incorporated opened at 55.89 on Wednesday. Watson Pharmaceuticals Incorporated has a 52-week low of $53.46 and a 52-week high of $73.35. The stock has a 50-day moving average of $60.82 and a 200-day moving average of $65.24. The company has a market cap of $7.107 billion and a price-to-earnings ratio of 38.44.

Pharmaceuticals should be much cheaper – ESRI

2012-01-25T02:29:00.000-08:00

PHARMACEUTICALS IN IRELAND are still too expensive, a new report from the ESRI has said.A range of measures, such as greater use of generic drugs, could be introduced to ensure that both cash-paying patients and taxpayers get better value for their money when it comes to pharmaceutical drugs, the report says.It suggests that pharmacists should be allowed to dispense pharmaceutical products which are interchangeable with that prescribed by a doctor. At present, the pharmacist has to dispense the brand written on the prescription, which may not be the cheapest option for the consumer.It also proposes that pharmacies should display dispensing fees, pharmacy services and mark-ups in-store so that patients can compare costs.A list of recommended generic alternatives for medical professionals should be compiled to increase the amount of generic drugs which are prescribed.Ireland had among the highest spend per person on pharmaceuticals in OECD countries in 2009.The report entitled ‘Delivery of Pharmaceuticals in Ireland – Getting a Bigger Bang for the Buck’ notes that healthcare costs rose rapidly in Ireland during the 2000s, even as health budgets now are under pressure. Pharmaceuticals currently make up around 17.5 per cent of public health expenditure, up from 14 per cent in 2000.

Formula Pharmaceuticals Appoints Martyn Greenacre to Board of Directors

2012-01-25T02:28:00.000-08:00

Formula Pharmaceuticals, a privately-held oncology drug development company, today announced the appointment of Martyn Greenacre to the Board of Directors. Mr. Greenacre served as Chairman of BMP Sunstone Corporation, a pharmaceutical company recently acquired by Sanofi-Aventis."Martyn is a highly-valued addition to our Board of Directors," said Maurits W. Geerlings, Chief Executive Officer of Formula Pharmaceuticals. "His proven leadership, coupled with his extensive business and corporate development experience in the pharmaceutical industry, will be invaluable to us as we advance our lead clinical-stage program."Previously, Mr. Greenacre served as Chief Executive Officer and Director of Delsys Pharmaceutical Corporation, a formulation and drug delivery system company, where he helped raise more than $50 million in equity and partnership financing and formed three development partnerships with leading pharmaceutical companies. Prior to that, Mr. Greenacre served as President and Chief Executive Officer of Zynaxis Inc., a biopharmaceutical company, where he was responsible for a critical acquisition, divesting a non-performing business and negotiating a strategic merger. Mr. Greenacre also held positions of increasing responsibility in the European division of SmithKline Beecham Pharmaceutical Company, rounding out his time there as Chairman, Europe."I am excited to join the Formula leadership team at a time when the company is moving its lead drug candidate, FPI-01, towards Phase 2 clinical development for the treatment of first-remission acute myeloid leukemia and other cancers," said Mr. Greenacre. "I look forward to contributing my knowledge and expertise to supporting major milestones that are on the horizon for the company."Mr. Greenacre has also served on a number of start-up company Boards and currently serves as Chairman of the Board of Acusphere, Inc. (a drug delivery company), as Chairman of Life Mist Technologies, Inc. (a hospital biological decontamination company), and sits on the board of Curis, Inc. (a biotechnology company). Mr. Greenacre received a B.A. from Harvard College and an MBA from Harvard Business School.

Watson Pharmaceuticals Incorporated (WPI) Shares Downgraded to “Neutral” by Citigroup (C) Analysts

2012-01-25T02:26:00.000-08:00

Watson Pharmaceuticals Incorporated (NYSE: WPI) was downgraded by investment analysts at Citigroup (NYSE: C) from a “buy” rating to a “neutral” rating in a note issued to investors on Tuesday.Separately, analysts at Goldman Sachs (NYSE: GS) reiterated a “conviction buy” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Monday. Analysts at Credit Suisse (NYSE: CS) cut their EPS estimates on shares of Watson Pharmaceuticals Incorporated in a research note on Monday. They now have an “outperform” rating and a $77.00 price target on the stock. Also, analysts at Needham & Company reiterated a “hold” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Monday.Watson Pharmaceuticals, Inc. (Watson) is an integrated global pharmaAceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic and brand pharmaceutical products. It operates in three segments: Global Generics, Global Brands and Distribution. It operates in international markets, including Western Europe, Canada, Australasia, Asia, South America and South Africa with its commercial market being the United States of America. As of December 31, 2010, it marketed approximately 160 generic pharmaceutical product families and approximately 30 brand pharmaceutical product families in the United States, and distributed approximately 8,500 stock-keeping units (SKUs) through its Distribution Division. In January 2010, the Company acquired 64% of Eden Biopharm Group Limited (Eden). In May 2011, it acquired Specifar Pharmaceuticals S.A.Shares of Watson Pharmaceuticals Incorporated traded down 2.88% during mid-day trading on Tuesday, hitting $55.56. Watson Pharmaceuticals Incorporated has a 52 week low of $53.46 and a 52 week high of $73.35. The stock’s 50-day moving average is $61.05 and its 200-day moving average is $65.34. The company has a market cap of $7.065 billion and a P/E ratio of 39.35.

Strides sells stake in arm to Watson Pharma

2012-01-25T02:25:00.000-08:00

The Bangalore-based pharmaceutical major, Strides Arcolab, sold its 94 per cent stake in Ascent Pharmahealth, a subsidiary with operations in Australia and Southeast Asia, to the U.S.-based Watson Pharmaceuticals which also acquired the remaining 6 per cent stake associated with Dennis Bastas, CEO of Ascent, in a move to restructure and focus its business.The cash offer from Watson values Ascent at an enterprise value of Australian $375 million ($392.5 million). Ascent is a top five generic pharmaceutical company in Australia and is present in countries across Southeast Asia.Strides develops and manufactures a wide range of IP-led niche pharma products with an emphasis on sterile injectables. It has 13 manufacturing facilities across five countries and has a 350-scientist strong global R&D Centre in Bangalore.Arun Kumar, Executive Vice-Chairman and Group CEO of Strides Arcolab, said, “The sale of Ascent is a value-enhancing and forward looking initiative for Strides. We have been clear about our intention to focus on our highly attractive steriles segment, which we expect to be our growth engine going forward. The transaction further facilitates the execution of this strategy and unlocks significant value for the Group. Furthermore, the proceeds from the transaction considerably strengthen our balance sheet.”T. S. Rangan, Group CFO, Strides Arcolab, told this correspondent that the steriles business contributed around 40 per cent of the company's revenues and about 70 per cent of the operating earnings. “Although Ascent enjoys operating multiple of 20, the highest in industry, its sale will help us restructure our $500 million debt by allowing us to retire around $250 million and will give us some flexibility. Importantly, the saving on the interest paid to service the debt can compensate for the sale of the Ascent business,” he said, adding that all Ascent's 307 employees would be absorbed by Watson.Watson is a specialty pharma company focussed on urology and women's health. Its President and CEO Paul Bisaro said the acquisition gave Watson a successful commercial structure in Australia and Southeast Asia and a broader product pipeline.Strides' generic business spans Australasia, Africa and India. After Ascent's sale, Strides' medium-term plan is to grow the injectibles business to global scale through its specialities' division Agila Specialties.

Douglas Pharmaceutical gets US approval for acne medication

2012-01-25T02:24:00.000-08:00

Local pharmaceutical company Douglas Pharmaceuticals has gained Food and Drug Administration (FDA) approval to sell and distribute its New Zealand developed acne medication ‘isotretinoin’ in the United States.Douglas Pharmaceuticals has been pushing to break into the US acne medication market for around ten years, which is currently worth around $US400 million ($NZ494 million).“This is a huge breakthrough for us and for New Zealand which will benefit from the increased export earnings,” Douglas Pharmaceutical director Jeff Douglas said.“We believe our isotretinoin is the first New Zealand developed human medicine to be approved for use in the US. It’s our biggest export product and is the market leader in Spain, Austria, Germany and Mexico. The US market has, however, taken a little longer to get approval but as the US is the largest pharmaceutical market in the world the potential for us is very exciting.”Mr Douglas says the first US orders will be despatched within the next month and a consumer launch is likely to be initiated around April or May of this year.

Macoven Pharmaceuticals, LLC Named In Suit For Patent Violation And Lanham Act Violation

2012-01-25T02:23:00.001-08:00

District Court for the Southern District of New York, - January 17, 2012 -- three plaintiffs filed a complaint against defendant, Macoven Pharmaceuticals, for patent infringement and false advertising.The three plaintiffs that are claiming patent infringement and false advertising are: Breckenridge Pharmaceutical, Inc. of Florida, Metabolite Laboratories, Inc. of Colorado and Pamlab, LLC of Louisiana.Metabolite was formed under the University of Colorado's guidelines by two hematology professors at the UC School of Medicine, Dr. Robert H. Allen and Dr. Sally P Stabler. Their careers were devoted to the study of Vitamin B12, Vitamin B6 and folate. Their clinical work has long been at the forefront of research examining the relationship between those vitamins and homocysteine. Their work has been widely published and has been awarded a number of United States patents.Pamlab, LLC, licensed Metabolite's patents and in 1999 launched a product containing vitamin B12, vitamin B6 and folic acid. Pamlab markets products to licensed physicians as a medical food intended for the specific dietary management of individuals under a physician's treatment for hyperhomocystenemia, with particular emphasis on individuals with or at risk for atherosclerotic vascular disease in the coronary, peripheral, or cerebral vessels, or individuals with vitamin B12 deficiency.In 2007, Breckenridge entered into a patent sublicense with Pamlab under several Metabolite patents, to begin exclusive marketing of a licensed generic version of Pamlab's product. Breckenridge's product is now distributed and dispensed at retail pharmacies nationwide.In addition to patent infringement, the plaintiffs allege that Macoven has failed to substantiate its claims that its folic acid product is a suitable substitute for Pamlab's and/or Breckenridge's products and that Macoven is in violation of the Lanham Act which prohibits false or misleading advertising.Plaintiffs have asked for an unspecified amount of damages, including treble damages from Macoven; an injunction preventing Macoven from selling or distributing its infringing product; and for attorney's fees.Macoven Pharmaceuticals is a fully owned subsidiary of Pernix Therapeutics Holdings, INC based in Texas and listed on the NYSE Amex (PTX).

Pharmaceutical companies owners: LHC grants three-day remand

2012-01-25T02:21:00.000-08:00

A judicial magistrate here Tuesday granted three-day remand of owners of pharmaceutical companies to Federal Investigation Agency for interrogation about alleged bogus medicines that caused several deaths in Punjab Institute of Cardiology.

Earlier, the agency sought 10-day remand of the accused, but the magistrate allowed only three days custody of the accused Tahir Azam, Chaudhry Nadir and Muhammad Wasim.The prosecution counsel argued before the court that at-least 65 patients had died while hundreds of others were affected after using medicines supplied by these companies.

The counsel said the medicines supplied by the companies were substandard while manufacturing and expiry dates were also not mentioned on them.On the other hand, counsel for the accused argued that the federal government took action against his clients in haste only to gain political mileage.

He said the federal government jumped into the provincial matter unnecessarily and without having any evidence against the companies.

The counsel alleged that the patients died due to negligence on part of doctors but the whole responsibility was being shifted to pharmaceutical companies.

Meth bill backers, pharmaceutical industry do battle

2012-01-25T02:20:00.001-08:00

A Kanawha County lawmaker working to make a dozen popular cold and allergy remedies available only by prescription said supporters of the idea are engaged in "hand-to-hand combat" with pharmaceutical lobbyists.Sen. Dan Foster, D-Kanawha, and Delegate Don Perdue, D-Wayne, are among the lawmakers pushing a plan to make pseudoephedrine products prescription-only. They met Monday with the Daily Mail editorial board.Pseudoephedrine is a key element in some popular medicines, but it's also the key ingredient in the street drug methamphetamine.Pseudoephedrine products already have been put behind the counter. An ID is required to buy them, and there is a limit on how much one person can buy in a month.None of that has stopped the meth problem.So, Foster and Perdue argue it's now time to make people get a prescription before they buy the type of Advil Cold and Sinus, Sudafed and other products that contain pseudoephedrine.The plan has met concerted opposition from the pharmaceutical industry. Industry lobbyists contend a multi-state tracking system would help law enforcement officials police meth-making without forcing consumers to get prescriptions.

Cubist Pharmaceuticals (CBST) – Research Analysts’ Recent Ratings Updates

2012-01-25T02:17:00.000-08:00

Cubist Pharmaceuticals (NASDAQ: CBST) received a number of ratings updates from brokerages and research firms in the last week:Cubist Pharmaceuticals had its “buy” rating re-affirmed by analysts at Bank of America.Cubist Pharmaceuticals had its “buy” rating re-affirmed by analysts at Jefferies Group. They now have a $50.00 price target on the stock.Cubist Pharmaceuticals had its “hold” rating re-affirmed by analysts at Needham & Company.Cubist Pharmaceuticals had its price target raised by analysts at RBC Capital from $46.00 to $49.00. They now have an “outperform” rating on the stock.Cubist Pharmaceuticals had its price target raised by analysts at Wedbush to $55.00.Cubist Pharmaceuticals was downgraded by analysts at Zacks Investment Research from a “neutral” rating to an “underperform” rating.

Teva Rises to Eight-Month High on Novartis News: Tel Aviv Mover

2012-01-23T21:59:00.000-08:00

Teva Pharmaceutical Industries Ltd. (TEVA) climbed to the highest level in almost eight months after U.S. and European regulators said they were reviewing Novartis AG (NOVN)’s multiple sclerosis pill Gilenya after reports of 11 deaths.The shares of Petach Tikva, Israel-based Teva, whose bestselling drug is Copaxone, an injectable treatment for multiple sclerosis, gained 0.9 percent to 173.50 shekels at the 4:30 p.m. close in Tel Aviv, the highest since May 31.“A slower introduction of oral treatments for multiple sclerosis will prolong the shelf life of injectable MS drugs such as Teva’s Copaxone,” Jonathan Kreizman, a Tel Aviv-based analyst at Clal Finance Brokerage Ltd. said today by phone.Teva shares declined 18 percent last year as competition to Copaxone increased and after the company introduced fewer generic drugs in the U.S. Annual sales of the treatment, which reached $3.32 billion in 2010, will probably peak at $3.8 billion, Teva said Dec. 21. Copaxone accounted for 24 percent of revenue in the third quarter of 2011.The reports of deaths among patients who took Novartis’s Gilenya raise concern that the first oral treatment for the debilitating neurological disease may harm the heart, the European Medicines Agency said Jan. 20. The U.S. Food and Drug Administration also is reviewing data on the medicine.Novartis said it’s working with the EMA on the review and is notifying doctors of the agency’s recommendation to increase monitoring of patients’ hearts after the first dose. Julie Masow, a spokeswoman for Novartis, said in an e-mail the death rate is in line with the broader expected death rates based on the 30,000 multiple sclerosis patients who have been treated with Gilenya to date.Jeremy Levin, who Teva named on Jan. 2 to replace Shlomo Yanai as chief executive officer, has an “impressive record” of identifying interesting branded drugs at an early stage, Kreizman said. Teva shares have soared 12 percent in Tel Aviv since Levin’s appointment.“Investors feel Teva now has a better chance to find another branded blockbuster like Copaxone,” he said.

Pharmaceutical Society of Ghana sues NHIA over the implementation of capitation system

2012-01-23T21:58:00.000-08:00

The Pharmaceutical Society of Ghana has sued the National Health Insurance Authority (NHIA) over the implementation of the newly introduced capitation system.

The NHIA is currently running a pilot scheme in the Ashanti region despite protests from some private health facilities and the Pharmaceutical Society.

The Pharmaceutical society said the use of health facilities which have not been licensed violates its regulations and also has the potential of pushing its members out of business and compromise on safety standards.

James Ohemeng Kyei, President of the Pharmaceutical Society of Ghana, explained to Joy News the “NHIA have accredited facilities and pharmaceutical service providers that have not been licensed by the Pharmacy Council to provide pharmaceutical services under capitation.”

He said, “here is a situation where the NHIA has accredited some premises that have not been licensed by the Pharmacy Council to provide pharmaceutical services and this contravenes the Pharmacy Act of 1994 (Act 489).”

James Ohemeng further noted that, “the NHIA has also accredited some pharmaceutical service providers who have not been registered,” this act by the NHIA, he said, “poses potential risk to public health and safety.”

Mr. Ohemeng Kyei said the society is asking the court to stop the implementation of the system and also cancel the involvement of unlicensed facilities.

According to him, “the Pharmaceutical Society has engaged the NHIA formally and informally and cautioned them about this looming danger but the authorities will not listen. We want to halt the implementation of the piloting” until the right thing has been done “and that is why we are going to law so that the court will take that decision to stop them.”

QualityStocks News - La Jolla Pharmaceutical Announces Acquisition of Novel Therapeutic, Significant Management Changes

2012-01-23T21:56:00.000-08:00

QualityStocks would like to highlight La Jolla Pharmaceutical Co., a publicly traded biopharmaceutical company dedicated to the development of treatments that significantly improve outcomes in patients with life-threatening diseases. GCS-100, the Company’s product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in cancer and chronic organ failure.In the company’s news Friday, La Jolla Pharmaceutical announced that it has acquired global development and commercialization rights to GCS-100, a novel therapeutic for cancer and chronic organ failure.GCS-100’s ongoing development as an anti-cancer and anti-fibrotic agent is supported by extensive preclinical and clinical investigation, including phase 1 and phase 2 clinical trials.La Jolla acquired GCS-100 from privately held Solana Therapeutics Inc. (Solana). In connection with the acquisition, former Solana CEO George F. Tidmarsh, M.D., Ph.D. will serve as La Jolla’s new president and CEO.“Having been involved in the clinical development of GCS-100 over the past several years, I am thrilled to have the opportunity to continue this compound’s development in the context of La Jolla,” Dr. Tidmarsh stated in the press release. “Targeting galectin-3 holds great promise in the treatment of a broad range of life-threatening conditions, and, with GCS-100, we have the most advanced galectin-3-targeting compound in development.”Dr. Tidmarsh has 22 years of experience in the biotechnology industry, including the successful clinical development of three FDA-approved drugs. In addition to his appointment and also in connection to the acquisition, Saiid Zarrabian was appointed as an independent director of the company. Former members of La Jolla’s management team, including Deirdre Y. Gillespie, M.D., president and CEO, and Gail A. Sloan, CPA, CPA, as well as several former board members, have resigned.

ICH Q-IWG issues simplified technical requisites for registration of pharmaceuticals for human use

2012-01-23T21:55:00.001-08:00

International Conference on Harmonization (ICH) Quality Implementation Working Group (Q-IWG) has prepared ‘Points to Consider’ covering topics relevant to the implementation of ICH Q8(R2), Q9 and Q10, which is a simplified Technical Requirements for Registration of Pharmaceuticals for Human Use.

The ‘Points to Consider’ are based on questions raised during the ICH Q-IWG training workshop and are not new but intended to provide clarity to both industry and regulators and to facilitate the preparation, assessment and inspection related to applications filed for marketing authorizations which was released in a 16-page document here recently.

The development approach should be adapted based on the complexity and specificity of product and process; therefore, applicants are encouraged to contact regulatory authorities regarding questions related to specific information to be included in their application.

Using the Quality by Design (QbD) approach does not change regional regulatory requirements but can provide opportunities for more flexible approaches to meet them. In all cases, GMP compliance is expected.

The scientific rationale and Quality Risk Management (QRM) processes are used to reach a conclusion on what are Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) are for a given product and process.

The Quality Target Product Profile (QTPP) describes the design criteria for the product, and should therefore form the basis for development of the CQAs, CPPs, and control strategy.

The information to determine CQAs and CPPs will help to develop control strategy, ensure quality of the product throughout the product lifecycle and increase product and process knowledge, besides enhance transparency and understanding for regulators and industry to enable evaluate the changes.

According to Q-IWG, the QTPP provides an understanding of what would ensure the quality, safety and efficacy of a specific product for the patient and is a starting point for identifying the CQAs.

As part of risk assessment, risk includes severity of harm, probability of occurrence, and detectability, and therefore the level of risk can change as a result of risk management. Quality attribute criticality is primarily based upon severity of harm and does not change as a result of risk management. The process parameter criticality is based on the probability of occurrence and detectability which could change with risk management, stated the document.

Considerations for documenting CQAs could cover severity of harm before taking into account risk control. A well-developed control strategy will reduce risk and play a key role in ensuring the QTPP is realized.

The lifecycle of the control strategy is supported by Pharmaceutical Development, Quality Risk Management (QRM) and the Pharmaceutical Quality System (PQS) as indicated in the ICH Guidelines ICH Q8(R2), Q9, Q10.

Pharma industry would need devise a control strategy. This is generally developed and initially implemented for production of clinical trial materials. It can be refined for use in commercial manufacture as new knowledge is gained. Changes could include acceptance criteria, analytical methodology, and introduction of real-time release testing.

The Pharmaceutical Quality System (PQS) strengthens the link between the product lifecycle stages, to facilitate the process validation lifecycle approach. Therefore equipment and facilities should be suitably qualified, including computerized systems and the personnel involved in process validation activities should be appropriately trained, stated the document.

Automation solution provided by APEX Automation and Robotics to pharmaceutical company

2012-01-23T21:54:00.001-08:00

APEX Automation and Robotics has supplied and installed an automated batch mixing process for an international pharmaceutical company at its Sydney-based factory.Previously, the batch mixing process at the factory was manually operated and relied on outdated devices. In addition, operators were required to record some production data for quality assurance purposes, and this process was not always reliable.APEX Automation and Robotics' engineering team developed an automation solution for this process, introducing new equipment to automate the product transfer from silos or bulk bags and the batch mixing process.To further streamline operations, APEX Automation and Robotics also consolidated the controls of both the new and existing equipment into one motor control centre with a single master PLC and an HMI (Human-Machine Interface) to operate and monitor the overall system.The new system also records and automatically sends production data to the factory network at the end of each batch.This information includes:batch numberstarting and stopping timeactual mixing time; andinterruptions.

Thomson Reuters Helps Brazil's Institute for Applied Economic Research Identify New Opportunities in the Generic Drug Landscape

2012-01-23T21:52:00.000-08:00

The IP & Science business of Thomson Reuters today announced an agreement with Brazil's Institute for Applied Economic Research (IPEA). This partnership provides IPEA's Direction of Sectorial Studies and Policies for Innovation, Regulation and Infrastructure (DISET) branch with access to the Newport suite of products, supplying them with generic pharmaceutical intelligence as well as with tools for business development and the sourcing of global active pharmaceutical ingredients.IPEA, a federal public foundation linked to the Strategic Affairs Secretariat of the Brazilian Presidency, provides technical and institutional support to the government for the development of public policies and development programs in Brazil. Within IPEA, DISET performs studies and evaluates public policies on science and technology, innovation, economic regulation, and antitrust.DISET will use Newport to find new opportunities to improve Brazil's national pharmaceutical infrastructure - in research, development and manufacturing - as well as the quality of its active pharmaceutical ingredients. In addition to the extensive generic drug information available through the Newport suite of products, the group will have access to the Newport Generic Deals module, providing seamless integration of nearly 10,000 generic industry deals since 1999."We are enthusiastic about the Newport database," said Professor Eduardo Fiuza, member of the Board of Sector Studies for DISET. "I have never seen so much information about and capabilities for the generic drug market assembled in one single database. It will certainly speed up our data search and contribute to our extensive inquiry on the Brazilian pharmaceutical market. I hope that coverage of Brazilian indicators increases even further in the future.""This is an exciting time in the evolution of Brazil's pharmaceutical development, and we are pleased to partner with DISET to ensure it meets its goals," said Jon Brett-Harris, executive vice president at Thomson Reuters. "Newport is an essential tool for uncovering new opportunities in the generic drug market, while the mergers and acquisitions data in our Deals module will help pave the way for further economic progress."

Watson Pharmaceuticals Incorporated (WPI) PT Lowered to $73.00 by Piper Jaffray (PJC

2012-01-23T21:51:00.001-08:00

Equities research analysts at Piper Jaffray (NYSE: PJC) decreased their price target on shares of Watson Pharmaceuticals Incorporated (NYSE: WPI) to $73.00 in a research note issued to investors on Monday.Separately, analysts at Canaccord Genuity reiterated a “buy” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Wednesday, January 18th. Analysts at Goldman Sachs (NYSE: GS) cut their EPS estimates on shares of Watson Pharmaceuticals Incorporated in a research note on Friday. They now have a “buy” rating and a $78.00 price target on the stock. Also, analysts at Jefferies Group (NYSE: JEF) reiterated a “hold” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Tuesday, December 20th. They now have a $70.00 price target on the stock.Watson Pharmaceuticals, Inc. (Watson) is an integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic and brand pharmaceutical products. It operates in three segments: Global Generics, Global Brands and Distribution. It operates in international markets, including Western Europe, Canada, Australasia, Asia, South America and South Africa with its commercial market being the United States of America. As of December 31, 2010, it marketed approximately 160 generic pharmaceutical product families and approximately 30 brand pharmaceutical product families in the United States, and distributed approximately 8,500 stock-keeping units (SKUs) through its Distribution Division. In January 2010, the Company acquired 64% of Eden Biopharm Group Limited (Eden). In May 2011, it acquired Specifar Pharmaceuticals S.A.Shares of Watson Pharmaceuticals Incorporated opened at 58.14 on Monday. Watson Pharmaceuticals Incorporated has a 52 week low of $53.46 and a 52 week high of $73.35. The stock’s 50-day moving average is $61.22 and its 200-day moving average is $65.50. The company has a market cap of $7.393 billion and a P/E ratio of 39.99.

APP Pharmaceuticals Settles With The Medicines Company on Angiomax(R) (Bivalirudin) Patent Litigation

2012-01-23T21:50:00.000-08:00

APP Pharmaceuticals, Inc., a Fresenius Kabi Company, announced today that it has settled its litigation with The Medicines Company relating to APP's Abbreviated New Drug Application for a generic version of the anti-clotting drug Angiomax(R) (bivalirudin for injection).Under the settlement, The Medicines Company has licensed APP to begin selling APP's generic version of Angiomax in the U.S. on May 1, 2019. Furthermore, in certain limited circumstances, The Medicines Company's license to APP would become effective prior to May 1, 2019, and may include the right to market an authorized generic bivalirudin product supplied by The Medicines Company.Additionally, APP entered into an agreement for the manufacture and supply of Angiomax(R) finished product to The Medicines Company. The agreements are subject to review by the Federal Trade Commission and the U.S. Department of Justice.In 2007, APP filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration to manufacture and market a generic version of Angiomax(R). In 2009, APP amended that filing to include Paragraph IV certifications with respect to two Medicines Company patents that were filed in 2009 and issued in 2010 and are listed in the Orange Book in connection with Angiomax(R). In response to these filings, The Medicines Company filed lawsuits against APP alleging that the proposed product would infringe those patents, which expire July 27, 2028. As part of the settlement with The Medicines Company, APP admits that the two patents asserted in the lawsuits are valid and enforceable against, and would be infringed by, APP's proposed generic bivalirudin product. The settlement also includes APP's agreement to dismiss its appeal of the August 2010 Federal District court decision holding that The Medicine Companies' application for Hatch Waxman patent term extension of the Angiomax composition of matter patent was timely filed.

Biostar Pharmaceuticals Selected by the FMMU to Cooperate in the Fields of Research and Product Development

2012-01-23T21:49:00.000-08:00

Biostar Pharmaceuticals, Inc. BSPM +0.25%("Biostar" or "the Company"), a developer, manufacturer and marketer of pharmaceutical and health supplement products for a variety of diseases and conditions, today announced that on January 8th it was one of nine PRC pharmaceutical companies selected to cooperate with The Fourth Military Medical University ("FMMU") (website: http://en.fmmu.edu.cn ) in the fields of research and product development.Established in 1954 and based in Xi'an, FMMU is one of China's most prestigious military medical universities and research centers. FMMU consists of several colleges specializing in: basic medicine, aerospace medicine, stomatology (the study of oral diseases), biomedical engineering, military services and statistics, pharmacology, nursing, and operates three modern hospitals: the First Affiliated General Hospital, the Second Affiliated General Hospital and the Stomatological Hospital.FMMU's primary purpose is to advance China's military medicine. Before selecting Biostar, to the best of the Company's understanding, FMMU screened various pharmaceutical companies, rating their achievements in several fields, including research and product development, their completion of clinical trials, and their products' significance in fighting widespread diseases.During his speech at the January 8th ceremony, which was attended by more than 3,000 doctors, university professors, leaders in the medical field, and executives from more than 500 pharmaceutical companies, Biostar's Chairman and Chief Executive Officer, Mr. Ronghua Wang, noted that Biostar will work with FMMU's staff to share resources and ideas and to carry out phases I to IV of clinical trials for products covered under the cooperation agreement. Additionally, based on and in accordance with prescribed military guidelines, Biostar's researchers will develop products which, when approved, will be sold directly to the PRC military and to the three hospitals managed by FMMU. The Company anticipates that its Zushima spray, a pain suppressant, which Biostar developed for China's military and has cleared clinical trials, will receive a military license shortly.Mr. Ronghua Wang noted, "We are proud to be one of only nine pharmaceutical companies in China selected to cooperate with FMMU. When compared to the other eight pharmaceutical companies in this group, Biostar is smaller, but our vertically integrated business model, our strong R&D, and our manufacturing and marketing capabilities were several of the reasons why Biostar was included in this group. For several years, we have been cooperating with many prestigious universities, such as Shaanxi College of Traditional Chinese Medicine, Shaanxi University of Science and Technology and the Northwest University - College of Life Science. We believe that through our cooperation with FMMU, we have positioned the Company to take advantage of the growth forecasted for the pharmaceutical industry. We remain committed to enhancing shareholder value by expanding our product range, increasing sales, and profitably growing our Company."

Salix Pharmaceuticals (SLXP) Shares Downgraded to “Market Perform” by JMP Securities Analysts

2012-01-23T21:48:00.000-08:00

Salix Pharmaceuticals (NASDAQ: SLXP) was downgraded by JMP Securities to a “market perform” rating in a research note issued on Monday.Separately, analysts at Stifel Nicolaus downgraded shares of Salix Pharmaceuticals from a “buy” rating to a “hold” rating in a research note to investors on Friday. Analysts at Piper Jaffray (NYSE: PJC) raised their price target on shares of Salix Pharmaceuticals to $57.00 in a research note to investors on Wednesday, January 4th. Also, analysts at Goldman Sachs (NYSE: GS) raised their price target on shares of Salix Pharmaceuticals to $46.00 in a research note to investors on Friday, December 23rd. They now have a “neutral” rating on the stock.Salix Pharmaceuticals, Ltd. is a pharmaceutical company engaged in acquiring, developing and commercializing prescription drugs used in the treatment of a variety of gastrointestinal disorders, which are those affecting the digestive tract. As of December 31, 2010, the Company’s products include XIFAXAN, MOVIPREP, OSMOPREP, VISICOL, APRISO, METOZOLV, AZASAN, ANUSOL-HC, PROCTOCORT, PEPCID, Oral Suspension DIURIL and COLAZAL. As of December 31, 2010, the Company’s primary product candidates under development include Rifaximin, Crofelemer, Balsalazide disodium tablet and Budesonide foam. In February 2011, the Company acquired the license to develop and commercialize the products containing methylnaltrexone (MNTX) Compound, marketed under the name RELISTOR, from Progenics Pharmaceuticals, Inc.Shares of Salix Pharmaceuticals opened at 46.11 on Monday. Salix Pharmaceuticals has a one year low of $25.64 and a one year high of $50.28. The stock’s 50-day moving average is $46.48 and its 200-day moving average is $36.5. The company has a market cap of $2.727 billion and a P/E ratio of 35.47.

Avraham Pharmaceuticals reports interim Alzheimer's trial success

2012-01-23T21:47:00.000-08:00

Avraham Pharmaceuticals Ltd.The interim report on ladostigil's safety profile found no serious or exceptional side effects, so the trial can continue from the safety aspect. The interim results also showed a positive trend in the drug's efficacy. The interim results are based on 179 patients, 66 of whom have undergone six months of therapy. The company added that the number of patients planned for the study was enough to provide statistically meaningful final results, and the expert panel therefore recommends pursuing the study. The company expects to complete the trial and obtain the results by the end of the year.Lagostil was jointly discovered by Prof. Moussa Yudim, Prof. Marta Weinstock-Rosin, and Prof. Michael Chorev. Prof. Youdim, of the Technion Medical School, is the discoverer of rasagiline, marketed by Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) as Azilect for the treatment of Parkinson's disease. Prof. Weinstock-Rosin of the Hebrew University in Jerusalem, and Prof. Chorev, of the Harvard Medical School, are the discoverers of rivastigmine, marketed by Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ) as Exelon, for the treatment of Alzheimer's.Teva acquired the drug, but returned it to Yissum Technology Transfer Company of the Hebrew University of Jerusalem, after investing tens of millions of dollars in developing and testing it. Avraham Pharmaceuticals bought the rights to the drug from Yissum, made some changes to it, and resumed trials for the treatment of Alzheimer's.Clal Biotechnology Industries Ltd. (TASE: CBI) said that, pursuant to the April 2010 investment agreement with Avraham Pharmaceuticals, it and the company's other investors, including Pontifax and Yissum. will exercise an option to invest $3.6 million in the company on the basis of the interim report. Clal Biotech's investment is $1 million, which will increase its stake in the company to 21%.

OPKO Health to Acquire Chilean Pharmaceutical Company

2012-01-23T21:46:00.001-08:00

OPKO Health, Inc. OPK +0.64% has entered into a definitive agreement to acquire ALS Distribuidora Limitada ("ALS"), a privately-held Chilean pharmaceutical company engaged in the business of importation, commercialization and distribution of pharmaceutical products for private markets.ALS started operations in 2009 as the exclusive product distributor of Arama Laboratorios y Compania Limitada ("Arama"), a company with more than 20 years of experience in the pharmaceutical products market. In connection with the transaction, OPKO will also acquire all of the product registrations and trademarks previously owned by Arama, as well as the Arama name.OPKO will acquire ALS for US $4 million in an all cash transaction from Inversiones SVJV Limitada, Inversiones BS Limitada, and Inversiones PYTT Limitada.Phillip Frost, OPKO's Chairman and Chief Executive Officer, commented, "This acquisition is an excellent strategic fit as OPKO expands its sales and distribution capabilities, particularly for its new pharmaceutical and diagnostic products."

Pharmaceutical Industry Places Newfound Emphasis on Managed Care Organizations

2012-01-23T21:45:00.000-08:00

As the influence of Managed Care continues to grow, so too do the activities that biopharma companies carry out as part of interacting with the managed care sector. Consequently, pharmaceutical and medical device leaders have placed an increased importance on these activities, as the strength of these organizations has become closely intertwined with marketplace success.On average, the Best Practices, LLC benchmark class drastically increased investment levels to $3 million per FTE in 2010 compared to one-half million in 2003. To meet the needs of Managed Care leaders trying to defend their resource and investment levels, Best Practices, LLC conducted a comprehensive research study to identify the industry standards for staffing data (FTE), outsourcing, budget and efficiency metrics.In addition, relative to 2003, Managed Care groups increased the percentage of budget allocated for payor pricing activity by 13% in 2010, according to "Resource Benchmarks for U.S. Pharmaceutical Managed Care Operations," a new primary research study conducted by Best Practices, LLC.

Pharmaceutical giant to settle Canadian class action suit on Vioxx

2012-01-23T21:44:00.001-08:00

Merck, the American based pharmaceutical giant, announced on January 19 it will settle class action suits in Canada connected to its controversial pain medication Vioxx.The company’s announcement, which comes five years after the firm settled similar claims in the US with a payment of over $4.5 Billion, indicates Merck will pay between $21 and 36.8 million to a group of affected Canadians, estimated by Mike Peerless, a lawyer involved in the case, as ranging between one and two thousand patients.But before the Canadian victims of Vioxx see any shares of the money Merck has agreed to pay, at least $10 million in fixed and legal costs will be deducted.The drug, withdrawn from the world market in 2004, had been promoted as a new “super aspirin”. But critics maintain Merck did not move quickly enough to end its sales after studies in 2000 suggested use of the blockbuster drug, which was eventually taken by more that 20 million patients, created elevated risks of cardiovascular problems and death.According to one estimate, over 55,000 deaths world wide were associated with Vioxx use. The drug generated huge revenues for Merck, which sold $2.5 billion worth of Vioxx each year until it was finally recalled.In BC, the UBC based Therapeutics Initiative was credited with saving over 600 lives by issuing an early warning about Vioxx dangers."This agreement is structured to provide certainty and finality toward resolving Vioxx cases in Canada for a fixed amount," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "Under the agreement, there will be an orderly, documented and objective process to examine individual claims to determine qualification."A company press release emphasized that Merck is not admitting any culpability in the case.“Merck continues to believe that the evidence shows the company acted responsibly with Vioxx,” the statement says, “ from the careful study in clinical trials involving about 10,000 patients before its approval by regulatory authorities around the world, through the careful safety monitoring while Vioxx was on the market, right up through the decision to voluntarily withdraw the medicine in September 2004.This agreement in Canada does not include any statement to the contrary and does not constitute any admission of liability.”

Pharmaceutical unit sealed FIA arrests three drug makers

2012-01-23T21:42:00.000-08:00

The Federal Investigation Agency (FIA) on Monday arrested three owners of as many companies for manufacturing drugs that allegedly caused the death of 63 cardiac patients registered with the Punjab Institute of Cardiology.The FIA has taken the action against the ‘will’ of the Punjab government. “Seeing the non-seriousness of the provincial government to lay hands on the people responsible for the deaths, the federal government directed the FIA to go for a direct action,” a senior official of the agency told Dawn.He said the agency would also expose negligent and corrupt provincial government officials, including doctors and drug inspectors.According to FIA spokesman Haroon Rashid, Tahir Agha of Mega Pharma, Wasim Chaudhry of Alfalah Pharma and Chaudhry Nadir Khan of Pharma-wise, have been arrested and a case under section 23/27 of Drug Act 1976 has been registered against them.He said the FIA initiated the probe on the direction of interior ministry. “Action will also be initiated against the provincial drug inspectors and officials of the drug testing laboratories,” he said.Meanwhile, PML-Q central information secretary Kamil Ali Agha said in a statement that Chief Minister Shahbaz Sharif holding the portfolio of health was responsible for the deaths. He said Mr Sharif had failed to form a team in four years to deal with the
health issues in the province. Mr Agha said first the chief minister was exposed in dengue epidemic and now the deaths owing to free suspected drugs reaction was another “feather” in his (Sharif) cap.Earlier, the Drug Testing Laboratory (DTL) of the Punjab government on Monday sealed a factory of a local pharmaceutical company — Mega Pharma — after analysis of a medicine – Cardiovestin — and declared it spurious.Meanwhile, the Federal Investigating Agency (FIA) launched on Monday a probe and directed the Punjab Institute of Cardiology administration to provide the agency with some information about the incident of drugs reaction to cardiac patients.The PIC authorities were directed to provide the FIA with pathological analysis of the suspected drugs, reports on clinical investigation relating to the patients and number of casualties took place so far owing to the use of the medicines.A source said Cardiovestin declared spurious by DTL was among those four medicines which had been kept under observation, including Alfagril, Concort and Soloprin, on the complaints of patients and consultants of various hospitals.These medicines were supplied to the PIC last month for distribution among the registered poor patients suffering from multiple cardiac diseases.According to a source, the DTL analysed 20mg Cardiovestin and allegedly detected a certain quantity of substandard substance.However, some experts were of the view that the DTL had no authority to declare any medicine substandard.“The DTL can only examine bio availability of the salt, efficacy of the salt and expiry of the salt of any medicine,” an expert told this reporter requesting anonymity. He said the DTL had no mandate to intervene in the process of the manufacturing of
medicines at any cost. Samples of the suspected drugs should be either pathologically analysed at the PCSIR laboratory or from abroad.The PIC has been distributing a combination of the four medicines among its registered cardiac patients for the last three weeks or so.Later, a good number of these patients were hospitalised owing to the reaction of the suspected drugs.

Launch of new lab awards

2012-01-23T20:44:00.000-08:00

A new awards scheme launched today is the first UK awards aimed at rewarding successful laboratory design, management and teaching within Higher Education as well as laboratories outside the sector.

The awards will recognise initiatives that create improved performance whilst enhancing safety and sustainability. There is significant potential in the UK to make labs more effective while saving money and improving environmental performance. E.g. the University of Edinburgh’s School of Chemistry saved £100,000 of the School’s chemical purchasing costs through ‘cradle to grave’ tracking of chemicals.

The awards are organised by S-Lab (Safe, Successful and Sustainable Laboratories), an initiative supported by the UK higher education funding bodies to create more sustainable laboratories and based at the University of Bradford.

In this first year there will be seven award categories:

· New or refurbished laboratory

· Laboratory effectiveness

· Laboratory environmental improvement

· Laboratory equipment and services

· Making a difference (for individuals)

· Laboratory-based teaching and learning innovation (education only)

· Schools and colleges (schools and colleges only)

S-Lab Director Peter James said: “Laboratories in all sectors are facing extremely challenging financial, technical, environmental and other pressures. With these Awards we hope to reward those labs and individuals who have adapted to changing requirements in innovative ways that both meet the need for sustainability as well as greater efficiency and effectiveness. The award winners will be the standard bearers for effective lab design, management and teaching.”

There will be a two-stage entry process, with an initial short application and a second stage with more information. The Stage 1 deadline will be 29 Feb 2012. Most categories are open to any organisations and laboratories in any sector, in any country.

The winners will be announced at the S-Lab conference, ‘The Effective Laboratory’, on 12-13 June 2012 at the National Science Learning Centre in York. The education-related categories are being assisted by the HEFCE-funded National HE STEM Programme (via the University of Bradford Greening STEM project and Regional Hub). Supporting organisations include HEaTED, the Royal Academy of Engineering, the Royal Society of Chemistry (RSC) and the Society of Biology.

Pherecydes Pharma receives €900,000 funding

2012-01-23T20:42:00.000-08:00

Pherecydes Pharma, a French biotechnology company specialising in the research and development of lytic bacteriophages for therapeutic and diagnostic purposes, has received funding of €900,000 from France’s General Directorate for Armaments (DGA).

The funding will part-finance the Pacoburns project, which is exploring the use of bacteriophages to combat bacterial infections that are resistant to antibiotics, especially skin infections.

The Institute of Genetics and Microbiology of the University of Paris XI and the Armed Forces Institute of Biomedical Research (IRBA) are also involved in this project. The University will handle electronic microscopy and bacteriophage sequencing, while IRBA will provide a mouse model adapted to the initial preclinical evaluations.

Using relevant animal models, Pacoburns will evaluate the therapeutic efficacy, safety and pharmacodynamics of two cocktails of bacteriophages.

The first is for infections caused by escherichia coli type bacteria, and the second for infections caused by pseudomonas aeruginosa, and more specifically for treating open burn wounds infected by these resistant germs. Trials on humans are scheduled to begin during 2013.

‘Despite optimising the use of antibiotics, situations of therapeutic impasse are increasingly common in the case of multi-resistant bacteria,’ said Patrick Jault, head of the burns treatment centre of Percy military hospital near Paris, and the future coordinator of the multicentre trial in man.

‘It is thus essential to explore new avenues, and bacteriophages are one of the most promising. It is now crucial to evaluate their merits and their therapeutic potential in humans.’

The Pacoburns project will enable Pherecydes Pharma to speed up the development of its leading therapeutic products, in particular through facilitating their future evaluation in man by the major burns units of military and civilian hospitals. The company then intends to extend the topical application of its cocktails to other skin pathologies (such as varicose ulcers), after that to test new products administered by aerosol and lastly by the internal route.

Takeda to axe 2,800 jobs by 2015

2012-01-23T20:40:00.000-08:00

Japanese pharmaceutical manufacturer Takeda Pharmaceutical Company, which recently bought Swiss drugmaker Nycomed, is to trim its workforce by 2,800 over the next four years.

Takeda says it will cut 2,100 jobs in Europe and 700 in the US and combine r&d sites or eliminate some subsidiaries, mostly in Europe by the end of 2015.

The company will align Nycomed’s former operation structures and processes with its global headquarters in Japan and the newly defined organisations of the Chief Commercial Officer, which is headquartered in Zurich, Switzerland, and Chief Medical & Scientific Officer, which is headquartered in Deerfield, Illinois and its expanded affiliate network worldwide.

‘The combination of Takeda and Nycomed, which we acquired on 30 September, brought together Takeda’s strong presence in the Japanese and US markets with the legacy Nycomed business infrastructure in Europe and high-growth emerging markets,’ said Yasuchika Hasegawa, president and chief executive of Takeda Pharmaceutical Company.

‘While our combined operations in more than 70 countries are more complementary than overlapping, there are a number of areas where we will need to make changes to ensure efficient and flexible operations moving forward.’

Takeda will also shift its focus from a product portfolio of mature, high selling products to a more diverse portfolio concentrating on new products.

The combined company has a commercial presence in the therapeutic areas of metabolic diseases, gastroenterology, oncology, cardiovascular health, CNS diseases, inflammatory and immune disorders, respiratory diseases and pain management.

Takeda says this restructuring will cost an estimated JPY70bn (US$912m; €709m) in total during 2011–2015. During this period, Takeda will achieve cost savings of approximately JPY200bn.

MHRA issues GMP certificate to AMRI plant in Wales

2012-01-23T20:38:00.000-08:00

The UK Medicines and Healthcare regulatory Agency (MHRA) has issued a Good Manufacturing Practice (GMP) certificate to AMRI’s plant in Holywell, Wales, following an inspection in October 2011.

The MHRA inspection follows a US Food and Drug Administration audit of the facility in June 2011, in which no formal observations were issued. The successful completion of both inspections means that AMRI’s Holywell facility can now produce registered intermediates and active ingredients for use in humans and expands the range of projects that the contract manufacturer can now conduct at this facility.

AMRI received the formal closeout of the MHRA inspection this month. The certificate covers general GMP manufacturing operations, and laboratory controls designed for the production and release of active pharmaceutical ingredients (APIs) and intermediates. The successful audit confirms AMRI’s compliance with European Medicines Agency GMP regulations and further demonstrates the company’s commitment to operational quality.

Steven Hagen, AMRI vice president of pharmaceutical development and manufacturing, said: ‘This certification completes an excellent year of regulatory cGMP audits for the Holywell facility and places it in a prime position to attract new business.’

In 2010, the FDA inspected AMRI’s Rensselaer, New York facility, which provides large-scale cGMP manufacturing, and no formal observations were issued. In the same year, the Italian Medicines Agency (AIFA) approved the Burlington, Massachusetts facility to manufacture a commercial drug product for a customer in the European Union.

Paragon Bioservices wins US$15m filovirus vaccine contract

2012-01-23T20:36:00.000-08:00

Paragon Bioservices, a US contract manufacturing organisation focused on the process development and manufacturing of biologics, has won a US$15m contract from the US Department of Defense (DoD) for the development and GMP manufacture of a trivalent filovirus vaccine.

‘It doesn't get any better than this for a CMO,’ said Marco Chacon, chief executive of Baltimore-based Paragon Bioservices.

Under the contract, the firm will combine its expertise in virus and vaccine (VLP) production and purification with experts from the University of Maryland School of Medicine (Baltimore, MD) and Harrisvaccines (Ames, IA).

During the first phase of the deal, Paragon Bioservices will receive $15m and this could more than double if optional contract line item numbers are exercised.

The contract focuses on the Venezuelan equine encephalitis (VEE) replicon particle trivalent filovirus vaccine.

There are currently no licensed vaccines or treatments against filoviruses, even though there is up to a 90% fatality rate in humans.

Paragon will develop a large-scale mammalian process that is suitable for cGMP manufacturing.

The firm is already working with filovirus vaccine candidates under another contract with the DoD awarded in October 2010, which involves process development and scale-up production to support the efficacy of filovirus vaccine candidates against the Ebola and Marburg viruses.

Patheon adds soft gel capsule capabilities through Procaps partnership

2012-01-23T20:32:00.000-08:00

Patheon and Procaps have agreed to provide a new line of soft-gel product development and manufacturing services to the pharmaceutical industry.

The offering will be branded as ‘P-Gels’ soft gels and the partnership will give Patheon rights to market Procaps’ soft gel technology and manufacturing capabilities in North America, Europe and Asia.

Procaps is a Colombia-based multinational company with more than 3,000 employees and manufacturing facilities throughout Latin America. It has been developing and manufacturing soft gel capsules since 1977 and currently has capacity to manufacture up to nine billion capsules a year.

‘This exclusive agreement is part of our recently announced strategy to strengthen our core operations and product offerings,’ said Jim Mullen, chief executive of Patheon.

‘By combining Procaps’ manufacturing capabilities and proprietary technology with our global experience, reach and customer service, we are positioned to provide our customers royalty-free soft gel capsule solutions for their products.’

The addition of commercial scale soft gel capacity to Patheon’s full range of dosage forms, which includes parenteral, solid and liquid technologies, builds on the firm’s SoluPath solution for compounds with solubility challenges.

Merck to settle Vioxx suits in Canada for CAN$36.8m

2012-01-23T20:05:00.000-08:00

Merck & Co has agreed to pay up to CAN$36.8m (US$36.5m) to resolve all lawsuits brought against it in Canada over its former arthritis drug Vioxx.

Merck voluntarily withdrew the medicine from the market in 2004 after clinical trials linked the anti-inflammatory drug to a higher risk of heart attack, stroke and death.

Under an agreement with plaintiffs in Canada, Vioxx users will share a payment of between CAN$11.3m and $26.4m depending on the number of final claimants. A further CAN$10.5m will be set aside for legal fees.

Merck said an independent administrator would evaluate claims for heart attack and sudden cardiac death on an individual basis according to the duration of Vioxx use, age and presence of risk factors. Individual awards for stroke claims will be up to CAN$5,000, the firm said.

Merck said it continues to believe that the evidence shows the company acted responsibly with Vioxx, from the careful study in clinical trials involving about 10,000 patients before its approval by regulatory authorities around the world.

‘This agreement is structured to provide certainty and finality toward resolving Vioxx cases in Canada for a fixed amount,’ said Bruce Kuhlik, executive vice president and general counsel of Merck.

The Canada deal will still have to be approved by the courts.

German scientists use oxygen and light to synthesise anti-malaria drug

2012-01-23T19:25:00.000-08:00

German researchers have discovered a process to make the most effective anti-malaria drug cheaper and easier to produce in large quantities.

Scientists at the Max Planck Institute of Colloids and Interfaces in Potsdam and the Freie Universität Berlin have developed a simple process for the synthesis of artemisinin, which pharmaceutical companies could only obtain from plants up to now.

The chemists use a waste product from current artemisinin production as their starting substance, which can also be produced biotechnologically in yeast, and convert it into the active ingredient using a simple yet ingenious method.

Peter Seeberger, director at the Max Planck Institute of Colloids and Interfaces in Potsdam and Professor of Chemistry at the Freie Universität Berlin and his colleague François Lévesque, said they used artemisinic acid, a substance produced as a by-product from the isolation of artemisinin from sweet wormwood, which is produced in volumes 10 times greater than the active ingredient itself. Moreover, artemisinic acid can easily be produced in genetically modified yeast as it has a simpler structure.

‘We convert the artemisinic acid into artemisinin in a single step,’ said Seeberger. ‘And we have developed a simple apparatus for this process, which enables the production of large volumes of the substance under very controlled conditions.’

The only reaction sequence known up to now required several steps, following each of which the intermediate products had to be isolated – a method that was too expensive to offer as a viable alternative to the production of the drug from plants.

The simplification of artemisinin synthesis meant the chemists had to depart from the paths typically taken by industry up to now. The effect of the molecule, which not only targets malaria but possibly also other infections and even breast cancer, is due to, among other things, a very reactive chemical group formed by two neighbouring oxygen atoms – referred to as an endoperoxide.

Seeberger and Lévesque used photochemistry to incorporate this structural element into the artemisinic acid. Ultraviolet light converts oxygen into a form that can react with molecules to form peroxides.

‘Photochemistry is a simple and cost-effective method. However, the pharmaceutical industry has not used it to date because it was so difficult to control and implement on a large scale,’ explains Seeberger. In the large reaction vessels with which industrial manufacturers work, flashes of light do not penetrate deeply enough from outside and the reactive form of oxygen is not produced in sufficient volumes.

The scientists say they have resolved this problem by channelling the reaction mixture containing all of the ingredients through a thin tube that they have wrapped around a UV lamp. In this structure, the light penetrates the entire reaction medium and triggers the chemical conversion process with optimum efficiency.

‘The fact that we do not carry out the synthesis as a one-pot reaction in a single vessel, but in a continuous-flow reactor enables us to define the reaction conditions down to the last detail,’ explained Seeberger.

‘We assume that 800 of our simple photoreactors would suffice to cover the global requirement for artemisinin.’

The scientists estimates that the synthesis process could be ready for technical use in about six months.

ICH Q-IWG issues simplified technical requisites for registration of pharmaceuticals for human use

2012-01-23T04:33:00.000-08:00

QualityStocks News - La Jolla Pharmaceutical Announces Acquisition of Novel Therapeutic, Significant Management Changes

2012-01-23T04:32:00.001-08:00

Teva Rises to Eight-Month High on Novartis News: Tel Aviv Mover

2012-01-23T04:31:00.001-08:00

Pharmaceutical Society of Ghana sues NHIA over the implementation of capitation system

2012-01-23T04:30:00.001-08:00

he Pharmaceutical Society of Ghana has sued the National Health Insurance Authority (NHIA) over the implementation of the newly introduced capitation system.

The NHIA is currently running a pilot scheme in the Ashanti region despite protests from some private health facilities and the Pharmaceutical Society.

The Pharmaceutical society said the use of health facilities which have not been licensed violates its regulations and also has the potential of pushing its members out of business and compromise on safety standards.

James Ohemeng Kyei, President of the Pharmaceutical Society of Ghana, explained to Joy News the “NHIA have accredited facilities and pharmaceutical service providers that have not been licensed by the Pharmacy Council to provide pharmaceutical services under capitation.”

He said, “here is a situation where the NHIA has accredited some premises that have not been licensed by the Pharmacy Council to provide pharmaceutical services and this contravenes the Pharmacy Act of 1994 (Act 489).”

James Ohemeng further noted that, “the NHIA has also accredited some pharmaceutical service providers who have not been registered,” this act by the NHIA, he said, “poses potential risk to public health and safety.”

Mr. Ohemeng Kyei said the society is asking the court to stop the implementation of the system and also cancel the involvement of unlicensed facilities.

According to him, “the Pharmaceutical Society has engaged the NHIA formally and informally and cautioned them about this looming danger but the authorities will not listen. We want to halt the implementation of the piloting” until the right thing has been done “and that is why we are going to law so that the court will take that decision to stop them.”

Pharmaceutical supplier promotes Sioux City native

2012-01-23T04:28:00.000-08:00

Sioux City native Bruce D. Johnson has been named vice president consumer healthcare research and development for pharmaceutical supplier Perrigo.Johnson will lead new product development for Perrigo's U.S. consumer healthcare business based in Allegan, Mich., with responsibilities also at research sites in New Jersey and India.Johnson joined Perrigo in 2005 and has played a critical role in the company's analytical research and development activities for both the U.S. and abroad.

La Jolla Pharmaceutical Acquires GCS-100 (LJPC)

2012-01-21T00:37:00.000-08:00

La Jolla Pharmaceutical Company (PINK: LJPC), a biopharmaceutical company engaged in the development of treatments that significantly improve outcomes in patients with life-threatening diseases, announced that it completed the acquisition of global development and commercial rights to GCS-100 from Solona Therapeutics Inc.

GCS-100 is a novel therapeutic. It is a first-in-class inhibitor of galectin-3, which is a novel molecular target implicated in cancer and chronic organ failure.

In relation with the acquisition of GCS-100, George F. Tidmarsh, M.D., Ph. D., who is the former CEO of Solona, has been appointed as LJPC’s President and CEO. Tidmarsh has more than 20 years of experience in biotechnology, including the successful clinical development of three FDA-approved drugs.

Tidmarsh said that having been involved in the clinical development of GCS-100 over the past several years, he is thrilled to have the opportunity to continue the compound’s development in the context of LJPC. Tidmarsh also said that targeting galectin-3 holds great promise in the treatment of a broad range of life-threatening conditions, and, with GCS-100, LJPC has the most advanced galectin-3-targeting compound in development.

In connection with the acquisition, the company has also appointed Saiid Zarrabian as an independent director of the company. Also, the former members of management team at LJPC, including Deirdre Y. Gillespie, and Gail A. Sloan, have resigned.

Galectin-3 plays a significant role in the immune system’s response to cancer and tissue injury, which makes specific inhibitors of galectin-3 attractive therapeutic candidates for a wide range of life-threatening diseases such as cancer, heart failure, kidney disease, pulmonary fibrosis and liver fibrosis.

GCS-100’s continuing development as an anti-cancer and anti-fibrotic agent is backed by extensive preclinical and clinical investigation. Experimental results show that GCS-100 specifically inhibits galectin-3 in immune cells isolated from patients, confers anti-cancer activity in patients with several tumor types, exhibits effects on the immune system in patients consistent with its galectin-3 inhibitory mechanism and is safe and well-tolerated at doses that confer clinical activity.

FDA Advisory Committee Declines to Recommend Approval of Progesterone Vaginal Gel 8% for the Reduction of Risk of Preterm Birth in Women with Short Ut

2012-01-21T00:36:00.000-08:00

Columbia Laboratories, Inc.CBRX -58.23% , and Watson Pharmaceuticals, Inc.WPI +0.72% , today confirmed that the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration (FDA) did not recommend approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy. While panel members generally agreed that progesterone vaginal gel 8% is safe, the panel stated that more information is needed to support approval.While the FDA will consider recommendations of the Committee, the final decision regarding the approval of the product rests solely with the FDA. The FDA's Division of Reproductive and Urologic Products is expected to take action on Columbia's New Drug Application (NDA) by February 26, 2012."We will work with the FDA to address the Advisory Committee's comments as the Agency finalizes its review of our NDA. We remain confident in the PREGNANT study results that showed the administration of progesterone vaginal gel 8% is a safe and effective treatment for patients at risk for preterm birth due to short uterine cervical length in the mid-trimester of pregnancy. We hope the agency's final decision will acknowledge the clear unmet medical need in this patient population," said Frank Condella, President and CEO of Columbia Laboratories, Inc."As was highlighted today, there are currently no products approved to reduce the risk of preterm birth in women with premature cervical shortening - an established strong predictor of preterm birth risk," said Fred Wilkinson, Watson's Executive Vice President, Global Brands. "The availability of a safe and effective product, with a demonstrated ability to reduce the risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy, would represent a significant advance in the prevention of early preterm birth and its associated complications."The Committee evaluated data submitted by Columbia to the FDA in its New Drug Application (NDA 22-139), which includes data from two Phase III clinical trials. One of these trials, the PREGNANT study, showed that women with a short uterine cervical length as measured by transvaginal ultrasound between 19 and <24 weeks of gestation who were treated with progesterone vaginal gel 8% had a significantly lower risk of preterm birth before 33 weeks gestation compared to those who were treated with placebo (p=0.022). This study included women with and without a prior history of preterm birth. Progesterone vaginal gel 8% was also associated with a significant reduction in the risk of preterm birth before 35 weeks gestation (p=0.012).In the PREGNANT study, the frequency of maternal treatment-emergent adverse events both overall and by individual event was comparable between the placebo and progesterone vaginal gel treatment groups. The most frequent events in the progesterone vaginal gel group were expected complications of a high-risk pregnancy and included "premature baby" (19%), "uterine contractions abnormal" (14%), "premature labor" (7%). "Cervical disorder" (10%), "nausea" (10%), "headache" (7%), and "vulvo vaginal mycotic infection" (7%) were also reported.

National Pharmaceutical Council Debuts Column, "From Methods to Policy," In New Journal of Comparative Effectiveness Research

2012-01-21T00:34:00.000-08:00

National Pharmaceutical Council (NPC) Chief Science Officer Robert W. Dubois, M.D., Ph.D., today debuted a column, "From Methods to Policy," in the new peer-reviewed, bimonthly publication, Journal of Comparative Effectiveness Research. Dr. Dubois also serves as an associate editor for the Journal.In his first column, Dr. Dubois outlines "the intended and unintended consequences of CER," as a way to spur further dialogue about the shape CER takes and how it ultimately impacts health care. In coming issues, Dr. Dubois' column will take a closer look at some of the challenges related to conducting, translating and disseminating CER."CER has great potential to improve medical decision-making and as a result our overall health. However, the detail of how we implement and use CER is critical to achieving this goal," wrote Dr. Dubois. "The idea of this column is to maintain a proper focus on the progress of CER as a tool for better health care, and where appropriate, shed light on the times when the CER debate goes in the wrong direction."The Journal is published by Future Medicine Ltd., based in North London, UK. Selected content from the launch issue can be viewed at http://www.futuremedicine.com/toc/cer/1/1 . To receive a free 30-day online trial to evaluate the Journal's content, please contact info@futuremedicine.com, with PRESSCER in the subject line.

McNicoll Lewis & Vlak Analysts Now Covering Avanir Pharmaceuticals Inc (AVNR) Stock

2012-01-21T00:33:00.001-08:00

Research analysts at McNicoll Lewis & Vlak assumed coverage on shares of Avanir Pharmaceuticals (NASDAQ: AVNR) in a report issued on Friday. They set a “buy” rating on the stock.Separately, analysts at MLV & Co initiated coverage on shares of Avanir Pharmaceuticals in a research note to investors on Friday. They set a “buy” rating and a $6.00 price target on the stock. Analysts at Canaccord Genuity reiterated a “buy” rating on shares of Avanir Pharmaceuticals in a research note to investors on Tuesday, December 13rd. Also, analysts at Jefferies Group (NYSE: JEF) reiterated a “hold” rating on shares of Avanir Pharmaceuticals in a research note to investors on Tuesday, December 13rd. They now have a $3.00 price target on the stock, down previously from $3.50.AVANIR Pharmaceuticals, Inc. (AVANIR) is a pharmaceutical company focused on developing and commercializing therapeutic products for the treatment of central nervous system disorders. The Company focuses on products for the central nervous system. It also has a number of partnered programs in other therapeutic areas. Its docosanol 10% cream, sold in the United States and Canada as Abreva by its marketing partner GlaxoSmithKline Consumer Healthcare, is the only over-the-counter treatment for cold sores that has been approved by the United Sates Food and Drug Administration (FDA). In October 2010, FDA approved NUEDEXTA, is a combination of dextromethorphan/quinidine, for the treatment of pseudobulbar affect (PBA).Avanir Pharmaceuticals opened at 2.87 on Friday. Avanir Pharmaceuticals has a 52-week low of $1.77 and a 52-week high of $4.80. The stock has a 50-day moving average of $2.23 and a 200-day moving average of $2.80. The company’s market cap is $364.4 millio

Cubist Pharmaceuticals (CBST) Given “Buy” Rating by Jefferies Group (JEF) Analysts

2012-01-21T00:32:00.001-08:00

Cubist Pharmaceuticals (NASDAQ: CBST)‘s stock had its “buy” rating reiterated by Jefferies Group (NYSE: JEF) in a research note issued on Friday.Separately, analysts at Bank of America (NYSE: BAC) reiterated a “buy” rating on shares of Cubist Pharmaceuticals in a research note to investors on Friday.Cubist Pharmaceuticals, Inc. (Cubist) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. The Company’s products are used primarily in hospitals, but also may be used in acute care settings, including home infusion and hospital outpatient clinics. Cubist’s owns CUBICIN (daptomycin for injection), which is a once-daily, bactericidal, intravenous (I.V.) antibiotic with activity against certain Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (S. aureus), (MRSA). During the year ended December 31, 2009, this product was used in the treatment of more than an estimated 880,000 patients. In December 2009, the Company acquired Calixa Therapeutics Inc.Cubist Pharmaceuticals opened at 40.40 on Friday. Cubist Pharmaceuticals has a 52-week low of $21.17 and a 52-week high of $42.10. The stock has a 50-day moving average of $39.25 and a 200-day moving average of $36.18. The company has a market cap of $2.487 billion and a price-to-earnings ratio of 70.14.

Absorption Pharmaceuticals to Attend Urological Conference with Its Ground Breaking Treatment for Premature Ejaculation

2012-01-21T00:30:00.000-08:00

Absorption Pharmaceuticals , makers of Promescent, a cutting edge treatment for premature ejaculation (PE), will participate in the Urology Association of Physician Assistants Conference (UAPA) in Las Vegas, NV January 20-22. Anthony Balchunas, President-Elect for UAPA, says "I am very excited about Absorption Pharmaceuticals being an active participant in our upcoming annual CME meeting in Las Vegas. The meeting promises to bring state-of-art lectures on a variety of Urological topics including several sessions focusing on sexual health issues. How fitting for Absorption, with their revolutionary product for the treatment of premature ejaculation (Promescent), to be a part of this inaugural meeting."According to Absorption Pharmaceutical CEO Jeff Abraham, one of the primary objectives at Absorption Pharmaceuticals is to educate physicians and clinicians about the physical and mental effects of premature ejaculation. PE affects 30% of the male population. Due to the lack of treatment options, PE is often confused or treated with erectile dysfunction medication. Often these patients suffer from both of these conditions and require dual therapy: pharmacological and behavioral.“Since our inception, we have worked closely with industry experts to insure the integrity of our educational and marketing efforts", says Abraham. "We are firmly committed to continuing the focus of utilizing our resources to strengthen our expanding presence in the areas of both Urology and sexual medicine."In 2011, Absorption Pharmaceutical participated in conferences sponsored by the America Urology Association (AUA) in Chicago, International Society for Men’s Health (ISMH) in Vienna Austria, Sexual Medicine Society of North America (SMSNA) in Las Vegas, and the European Sexual Society of Medicine (ESSM) in Milano, Italy. In addition to the upcoming UAPA meeting in January, Absorption Pharmaceuticals will also be sponsoring an educational lecture at the Association of Sexual Educators, Clinicians, and Therapists (ASECT) conference in June in Austin. AP has also planned to participate in the SMSNA/ISSM conference in August in Chicago.Mr. Balchunas adds, “One of our goals for the upcoming UAPA meeting is to bring valuable, up-to-date information and education to the participants in attendance. Products like Promescent positively impact the way we treat our patients and educate them about the common problem of PE. We appreciate Absorption's role in the support of the education process. The end result is better patient care as more clinicians become aware of Promescent's efficiency, safety, cost-effectiveness, and ease of use."

Glenmark eyes 20% sales growth in India speciality biz in 3yrs

2012-01-17T21:07:00.000-08:00

Glenmark Pharmaceuticals expects sales of its speciality business, which focuses on branded products, to grow by around 20 percent in India in the next three years.

"The objective of the India business is to grow 18-20 percent sales CAGR for the next three years. India, Russia and Brazil to remain focus markets," Glenmark said in an investor report.

The Mumbai-headquartered firm's sales from speciality segment from the Indian market stood at USD 55 million (over Rs 280 crore) for the second quarter ended September 30, 2011.

The company said it also plans to build expertise around therapeutic areas like dermatology, respiratory and oncology, across all operating regions.

In generics segment, which focuses on marketing of active pharmaceutical ingredients (APIs) and generic formulations, the company intends to focus its ANDA filings in three niche therapeutic areas -- dermatology, hormones and oncology.

Commenting on its first-to-file opportunities in the generics segment, the company said it will be launching four drugs between March, 2012 and December, 2016, including cholesterol-lowering Ezetimibe.

The drugs, which the company plans to launch as first-to-file, includes Hydrocortisone Butyrate Cream, used to treat skin inflammation and Fluticasone Lotion used to treat skin pain and itching caused by eczema.

Glenmark has already launched Atovaquone & Proguanil HC, an anti-malaria drug, in September, 2011.

According to MAT January data 2011, Ezetimibe, Hydrocortisone Butyrate and Fluticasone Lotion had sales of USD 1.3 billion, USD 38 million and USD 49 million, respectively.

On the innovation front, the company plans to initiate clinical development of at least one new molecular entity (NME) each year.

"New target areas to be preferably first in class globally. Focus areas for research will remain inflammation, pain and oncology," the report said.

The company also plans to continue with the out-licensing model and simultaneously build capabilities to do late stage development work, it added.

Novartis To Eliminate Nearly 2,000 Jobs In The U.S.

2012-01-17T21:06:00.000-08:00

Novartis has announced plans to eliminate 1,960 jobs in its divisions in the United States over the next year. The pharmaceutical giant said 1,630 sales positions in the field and 330 posts at its U.S. headquarters in New Jersey would be affected. These actions follow the elimination of 1,400 U.S. sales positions in 2010 and the cutting of 900 development positions in October of 2011.Novartis expects the job cuts to save the company around $450 million per year beginning in 2013. The layoffs will cost the company a one-time charge of $160 million. No mention of the recent recall in the U.S. of several over the counter drugs manufactured by Novartis was made with the announcement. The recall was initiated after reports surfaced of a possible mix-up with powerful prescription pain medications at a manufacturing plant in Nebraska.The restructuring is due in part to the anticipation of lower sales for two of the company’s hypertension drugs: the expiration of the patent for Diovan, a best seller, and the failure of a clinical study into Tekturna, another hypertension drug. The expiration of the patent for Diovan and increased competition from generics are expected to dramatically reduce the income from Diovan in the near future. Diovan increased Novartis’ net pharmaceutical sales by $1.43 billion, to 8.16 billion, in the third quarter.The company announced that a reassessment of Tekturna’s future sales potential after the termination of the clinical trial into expanded usage of the drug would result in a $900 million charge in the fourth quarter. The clinical trial was canceled after the drug was found to increase complications in patients taking other common hypertension medications. Two other experimental medications will also be dropped.Head of Novartis’ pharmaceuticals division, David Epstein, said in a statement, “We recognize that the next two years will be challenging in the Pharmaceuticals Division and we are proactively making these changes to further focus our pipeline on the best opportunities and align our market position on our growth brands. These are difficult but necessary decisions that will free up resources to invest in the future of our business which we view as well suited to bring new valuable therapies to patients and payors.”

Kedem Pharmaceuticals Completes North American Dosage Forms for X-Excite

2012-01-10T23:23:00.000-08:00

Kedem Pharmaceuticals Inc. KDMP +7.48% , a specialty pharmaceutical company with focus on sublingual drug delivery is pleased to announce that has completed all the dosages production of X-Excite, the Company's lead therapeutic drug for erectile dysfunction.Three dosages of the drug were manufactured with the final dosage forms (10, 25 and 50 mg) and appropriate labeling. The Company awaits the data from the labs on the dosages stability and disintegration studies. These studies are underway currently and once all completed, the Company can move towards the North American Clinical Trials."We are very pleased with the completion of dosage form and labeling, a requirement of regulatory bodies for the eventual drug approval," said Dr. Hassan Salari, Chairman and CEO of Kedem Pharmaceuticals Inc.

Pharmaceutical Company Warns of Opana, Percocet Painkiller Shortages

2012-01-10T23:22:00.000-08:00

Painkillers like Percocet and Opana from Endo Pharmaceuticals may be in short supply after their production facility was shut down for manufacturing and quality issues, the company warned.Novartis, the maker of certain painkillers for Endo, said on Sunday it was shutting its plant in Lincoln, Nebraska, to fix problems such as pills getting chipped or broken in the production process, or medications getting mixed. Novartis could not say how long the plant would be closed.Quality issues and manufacturing problems contribute to most drug shortages in the United States, where 220 medicines were in short supply last year, up from 56 in 2006.Novartis was the only manufacturer of an extended-release version of Opana, Endo's opioid pain drug. Endo said it was warning doctors not to prescribe Opana to new patients until it could devise other options to producing the pills.The Food and Drug Administration, the U.S. drugs regulator, said there are alternatives to Opana, such as painkillers based on hydrocodone, oxycodone and morphine.Endo shares fell 2.2 percent in afternoon trading on Nasdaq, versus a small gain in the S&P Pharmaceuticals Index.Endo said other painkillers such as Percocet and Endocet could be made at a separate facility in Huntsville, Alabama."Given existing inventories, the expected restart of Novartis production and our ability to shift production to other facilities we believe the supply constraints of our products should be limited," said Julie McHugh, chief operating officer of Endo Pharmaceuticals, in a statement.The FDA said on Monday there was a small chance that stray pills from Endo could have gotten mixed in with a different medication during production. Patients should stop taking their painkillers if any pills look different from the rest, the agency said.But the agency said it was not asking Endo to recall its medicines, since the likelihood of a mix-up was low, and the painkillers are medically necessary.Endo said it was aware of only three product mix-ups since 2009, and each time, pharmacists noticed the problem before the drugs reached patients.

Shanghai Pharmaceuticals Makes Breakthrough in Manufacturing M&A since H-Share Listing

2012-01-10T23:20:00.000-08:00

Shanghai Pharmaceuticals Holding Co. Ltd., ("Shanghai Pharmaceuticals" or the "Company" and, together with its subsidiaries, the "Group; stock code: 601607.SH; 02607.HK), is pleased to announce that 2011 marks another meaningful year for the Company since the listing of its A Shares on the Shanghai Stock Exchange after the Company successfully merged with Shanghai Industrial Pharmaceutical Investment Co., Ltd ("Shanghai Industrial Pharma") and Shanghai Zhongxi Pharmaceutical Co.,Ltd. ("Zhongxi Pharmaceutical") by absorption in 2010.The Company has been listed on the Hong Kong Stock Exchange since 20 May 2011, completing its overseas offering. The Company issued 696,000,000 H Shares which accounted for 25.9% of the expanded share capital. The offer price was HK$23 per share and a total of HK$16 billion was raised. The IPO was the largest overseas among the Chinese enterprises in 2011 and the world's top ten in the same year.Since its H share listing, the Company has gradually enhanced its industry position, while revenue and profit from its core business surged to their new highs. Industry experts predicted that the pharmaceutical M&A market will become turbulent in 2012. The Company has accelerated its move in M&A this year. Yesterday, one of the wholly-subsidized company of Shanghai Pharmaceuticals, Shanghai Zhongxi Sunve Pharmaceutical Co.,Ltd. ("Zhongxi Sunve") entered into an investment agreement with Shanghai Jinhe Bio-Technology Co., Ltd ("Jinhe Bio-Technology") for acquiring a 51% equity interest in Jinhe Bio-Technology. This acquisition will increase the investment in the area of anti-tumor active pharmaceutical ingredients (APIs).Anti-tumor drugs have been the fastest growing category of medicine in China in recent years, with a growth rate much higher than the pharmaceutical industry average. Among the anti-tumor drugs, the natural botanical type, especially taxanes (such as taxol and docetaxel), represents the largest proportion. Jinhe Bio-Technology is a high-tech enterprise engaged in the research, manufacturing and sales of botanical anti-tumor APIs as well as intermediates. The anti-tumor taxanes Jinhe Bio-Technology develop and produce fill the domestic gap and meet the domestic demand with a market share of over 50%. Jinhe Bio-Technology currently focuses on three types of botanical anti-tumor products, namely taxanes from taxus biomass, irinotecan from camptotheca acuminate and podophyllotoxin from podophyllum hexandrum, and has obtained a number of patents in these segments. With products that meet international standards, Jinhe Bio-Technology is recognized as an incubating technical "little giant" enterprise by the Science and Technology Commission of Shanghai Municipality.Zhongxi Sunve, a core subsidiary of Shanghai Pharmaceuticals specializing in APIs and related formulations, has received manufacturing approvals for the APIs of taxol and docetaxel in China at fairly early years. After this collaboration, both parties can integrate their resources and join hands together to quickly develop competitive advantages in botanical anti-tumor medicine. The investment mainly covers the construction of new plants that meetChina's GMP and U.S. FDA requirements. The new company is expected to be developed into a botanical anti-tumor drug API manufacturer with the largest domestic market share as well as global influence within a time frame of three years.

Radiant Sage Partners With Major Pharmaceutical Company to Enhance Open Source Clinical Trial Imaging Tool

2012-01-10T23:19:00.001-08:00

Radiant Sage LLC, a provider of on-demand Clinical Trial Image Management solutions, today announced that it has partnered with one of the world's leading pharmaceutical companies to enhance and re-launch its open source DICOM images submitter solution, now named ImageLink. The significantly enriched tool will be a fully validated and supported open source solution that will enable clinical trial sponsors and their partners to submit and share images through one common user interface."During a clinical trial, image transfer between the sponsor and their partners can be a very cumbersome process as images and related data are captured and organized differently by the various acquirers. Our pharmaceutical partner realized the need for one open source solution that could be used by all of its partners which would enable images to be transmitted in a standardized format and organized to meet the specific clinical trial requirements," said Venkatesan Thangaraj, CEO and president at Radiant Sage. "Together, our objective is to turn the ImageLink tool into a valuable, validated and fully supported solution that will help drive its adoption rate rapidly among the potential end-user organizations."Through the partnership, the two organizations are integrating this tool as a plug-in to Radiant Sage's Corelab-in-a-Box(TM) and Image Collaborative Portal solutions. Radiant Sage will ensure the tool is authenticated by the necessary industry organizations, regularly update and maintain the solution, and serve as the technology provider to support end users. The open source model will also enable end users to further customize the application as desired and submit their changes back to the open source repository for others to share."We believe our current pharmaceutical partner will benefit immensely from having one common interface to use for its multiple vendors and from the adaptability and ease of integration of this open source tool," added Thangaraj. "Our longer-term vision is making this tool an industry standard so that all sponsors and vendors will have one, customizable tool for transmitting clinical image data organized in the required manner."

Next IT Expands Bench of Pharmaceutical Industry Expertise

2012-01-10T23:18:00.001-08:00

Next IT, a leading provider of Intelligent Virtual Assistants for business, is expanding its sales team to address the significant customer support needs of the healthcare and pharmaceutical industries. Victor Morrison and Mitch Lawrence, formerly of Teva Pharmaceutical Industries, bring valuable experience and perspective to tailor online self-service solutions that improve pharmaceutical compliance and healthcare outcomes.During his 22 years at Teva -- the world's largest manufacturer of generic drugs and a world leader in the treatment of multiple sclerosis (MS) -- Victor played a critical role in defining Teva's vision for pharmacy and specialty pharmacy interaction. He also conceived and developed the parameters for the clinical study of an enhanced interface between MS patients, specialty pharmacies and physicians and its impact on compliance, adherence and, most importantly, patient outcomes."Next IT's Human Emulation Technology will transform the patient experience," says Mr. Morrison. "It gives patients the ability to interact with a virtual assistant knowledgeable about them, their disease and their therapy, 24/7, via the web, smartphone or SMS. From the payer perspective, healthcare entities will have unlimited opportunities to engage the patient with dosing reminders, education, coaching and counseling and, importantly, to move the interaction to a live pharmacist or nurse when appropriate. Compliance and adherence to medication regimens should be dramatically increased, which will lead to better outcomes while decreasing the overall cost of care."Mitch Lawrence, with nearly 27 years of experience in sales gained in medical, pharmaceutical and information technology, is a born leader with a knack for the creation and development of highly effective sales and account-management teams. Most recently, he was accountable for all of Teva's formulary, contracting and brand initiatives with third-party payer accounts in the Western U.S., overseeing and training an award-winning staff of account managers."Advancing Next IT's technology across the healthcare industry is an exciting prospect. The potential benefit is huge," says Lawrence. "Conversational interfaces allow people to use their own words to find the exact piece of information they're looking for, allowing electronically stored resources to be of much greater practical value because they're easier to use. I can see widespread applications, from guiding people through insurance billing forms to answering questions about medications and more. It truly gives patients a powerful tool for efficiently and effectively serving themselves."

Omni Bio Pharmaceutical to Present at Noble Financial Capital Markets' Eighth Annual Equity Conference on January 18

2012-01-10T23:17:00.000-08:00

Omni Bio Pharmaceutical, Inc. ("Omni Bio")OMBP 0.00% , a clinical-stage biopharmaceutical company, today announced that it will present at Noble Financial Capital Markets' Eighth Annual Equity Conference being held January 17 & 18 at the Hard Rock Hotel & Casino in Hollywood, Florida.Dr. James Crapo, Omni Bio's chief executive officer, is scheduled to speak on Wednesday, January 18 at 1:30 p.m. Eastern time (11:30 a.m. Mountain time).Conference and presentation details will be made available at the Omni Bio website at www.omnibiopharma.com . An archived presentation will be available on the website for 30 days.About Omni Bio Pharmaceutical, Inc.Omni Bio Pharmaceutical, Inc. ( www.omnibiopharma.com ) is a clinical-stage biopharmaceutical company that has licensed potential new indications for an existing FDA approved drug -- Alpha-1 antitrypsin (AAT). Omni Bio's core technology is based on issued patents and patent applications licensed from the University of Colorado Denver (UCD) and a privately held company, Bio Holding, Inc. Omni Bio's lead development program has been funding research and a human clinical trial to evaluate the effectiveness of AAT in the treatment of Type 1 diabetes. Novel discoveries made at UCD indicate that AAT has the potential to address a variety of indications in the areas of diabetes, transplant rejection and bacterial and viral disorders.Omni Bio is also a significant investor in BioMimetix Pharmaceutical, Inc. (BioMimetix), a recently formed biopharmaceutical corporation. BioMimetix is the exclusive licensee of an issued patent held by Duke University, and intends to develop a new class of patented compounds for the treatment of various diseases including radiation toxicity during the treatment of cancer using radiation therapy.

NovaBay Pharmaceuticals Announces Strategic Marketing Agreement for NeutroPhase in China

2012-01-10T23:16:00.000-08:00

NovaBay(R) Pharmaceuticals, Inc. NBY +3.08% , a clinical-stage biotechnology company developing its first-in-class, anti-infective Aganocide(R) compounds for the local non-systemic treatment and prevention of antibiotic-resistant infections, today announced it has entered into a commercial partnership agreement with Pioneer Pharma Co., Ltd., a Shanghai-based company that markets high-end pharmaceutical products into China, for the commercialization of NeutroPhase in this territory. Under the terms of the agreement, NovaBay will receive an upfront payment of over $300,000, with the potential for additional payments totaling approximately $1 million that may be triggered by certain regulatory milestones pre commercial launch.NeutroPhase is a U.S. Food and Drug Administration (FDA)-cleared wound cleanser developed by NovaBay to promote healing and improve clinical outcomes for patients with chronic non-healing wounds, including Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin."We are pleased to announce our partnership with Pioneer Pharma, whose sales network covers every province of Mainland China, including over 7,500 hospitals and 40,000 pharmacies," said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay. "We are also proud to be counted among Pioneer's strategic partners, which include several leading global pharmaceutical companies, including Alcon and Takeda.""We are excited to partner with NovaBay for the sales and marketing of NeutroPhase in China," stated President of Pioneer, Mr. XinZhou "Paul" Li. "We believe NeutroPhase represents a significant advancement in the care of chronic non-healing wounds that translates into a large market opportunity here in China. Our 1,000+ member sales force is looking forward to launching the product."Under the exclusive agreement, NovaBay will be responsible for preparation and submission of a Marketing Approval Application (MAA) for NeutroPhase, which will be reviewed by China's State Food and Drug Administration (SFDA). The MAA in China will be based on the data in the U.S. FDA 510(k) of NeutroPhase and NovaBay does not expect the SFDA will require further clinical testing for approval. NovaBay will export NeutroPhase finished product to Pioneer for sale in Mainland China following its expected approval. NovaBay has retained rights to commercialize or partner NeutroPhase in select Chinese markets not covered by the agreement, including Hong Kong, Macau, and Taiwan.Dr. Najafi continued, "NeutroPhase is our first FDA-cleared commercial product and announcing our first strategic marketing partnership for NeutroPhase represents a significant milestone for the Company. As we continue to seek additional partners for NeutroPhase in global markets, we remain on track for potential commercialization of NeutroPhase in the United States in the first quarter of 2012."

Ohr Pharmaceutical Awarded U.S and European Composition of Matter Patents

2012-01-10T23:15:00.000-08:00

Ohr Pharmaceutical Inc. OHRP 0.00% today announced that it has been awarded Unites States (#8,084,039) and European (EP1399108) patents entitled "Preparation of a Therapeutic Composition." The patents include claims related to the chemical structures, sequences of the peptide constituents and method of manufacture of OHR/AVR118."These patent awards significantly strengthen our OHR/AVR118 cancer cachexia program currently being investigated in a Phase II clinical trial," stated Dr. Irach B. Taraporewala, Ph.D., CEO. "OHR/AVR118 has the potential to greatly benefit advanced cancer patients suffering from the debilitating effects of cachexia. Stronger, more stable patients have a much better chance of tolerating the intense chemotherapies and radiation therapies involved in treating late stages of cancer."Dr. Taraporewala will be presenting a corporate overview at the Biotech Showcase(TM) 2012 in San Francisco, CA today at 4:30 p.m. PT (7:30 p.m. ET). The presentation will include an overview of Ohr's clinical wet-AMD eye drop and cancer cachexia programs along with the Company's business outlook and expected milestones for 2012.

AMAG Pharmaceuticals Provides Business Update

2012-01-10T23:13:00.000-08:00

AMAG Pharmaceuticals, Inc. AMAG +5.11% today announced a business update, including preliminary fourth quarter 2011 financial results and its outlook for 2012. The company will present further details at the 30th Annual J.P. Morgan Healthcare Conference in San Francisco on January 11, 2012 at 3:00 p.m. Pacific time.Fourth Quarter 2011 Business Highlights and Estimated Financial Results (unaudited)-- Over the course of 2011, the company successfully completed the transition of Feraheme(R) provider demand from both dialysis and non-dialysis sites of care to entirely non-dialysis sites of care. Feraheme non-dialysis provider demand for the fourth quarter of 2011 was approximately 24,250 grams(1), consistent with the third quarter of 2011, but 20% percent higher than the fourth quarter of 2010. Of particular note is Feraheme's growth in the hematology/oncology market segment, which increased approximately 65% in 2011 over 2010.-- AMAG expects to report fourth quarter 2011 total revenues of between $14.3 and $15.0 million, including between $12.4 and $13.1 million in net Feraheme product revenues. Total operating costs and expenses are expected to be between $38 and $43 million, including certain restructuring costs and a $2 million termination fee paid to Allos Therapeutics.-- AMAG implemented a restructuring plan on November 4, 2011 to align its operating expenses with projected Feraheme revenues. The restructuring plan included a reduction in force of approximately 25 percent and was designed to position the company to achieve cash flow breakeven in 2012 without impacting growth of Feraheme sales. The company's field sales team was realigned to a more strategically targeted account list and the number of territories was reduced from 72 to approximately 55 during the fourth quarter. The restructuring also included changes to the executive leadership team at AMAG, including the company's chief executive officer and chief commercial officer.-- AMAG hired Jefferies & Company, Inc. as a strategic advisor. Jefferies is assisting the company in identifying and evaluating various strategies to enhance stockholder value and leverage AMAG's core assets -- Feraheme, AMAG's commercial and drug development infrastructure, and the company's balance sheet, which had more than $225 million in cash and investments, and no debt, as of December 31, 2011."AMAG is committed to pursuing all avenues to maximize value for our shareholders, including the potential sale of the company," said Frank Thomas, chief operating officer and interim chief executive officer of AMAG. "While we intend to complete our evaluation of the viability of a sale of the company expeditiously and are pleased with our current progress, we remain focused on establishing a solid foundation from which to drive future growth and stockholder value if the company is not sold."Thomas continued, "Commercially, we have set out three key imperatives for 2012 -- to drive increased provider demand over the comparable 2011 periods, to optimize the pricing strategy for Feraheme ahead of the potential launch of the broad iron deficiency anemia label, and to strengthen our commercial leadership team. Already this year, we are making progress on these initiatives and are fortunate to have attracted a commercial industry veteran to join our ranks -- John Tucker started with AMAG last week as our new vice president of commercial operations. I believe that the addition of John to our management team will bring a fresh commercial perspective and the drive that we need to continue to grow the Feraheme brand."Mr. Tucker brings a strong set of experiences to AMAG, including as president of U.S. commercial operations at Basilea Pharmaceuticals, EVP of sales & marketing at Indevus Pharmaceuticals, senior director of government and institutional sales of Alza, and various senior commercial roles at both biotech and large pharmaceuticals companies. Mr. Tucker brings valuable hospital experience to AMAG, including the development and leadership of the Alza hospital sales team and creation of the U.S. launch plan for Basilea's hospital anti-infective portfolio.Global and Indication ExpansionDuring 2012, AMAG will continue to work with its partner, Takeda Pharmaceutical Company Ltd., in an effort to obtain approval of Feraheme for the treatment of iron deficiency anemia (IDA) in CKD patients in additional territories.-- A Marketing Authorization Application for Feraheme for the treatment of IDA in patients with CKD is under review by the European Medicines Agency. AMAG recently requested, and was granted, a 60-day extension to the filing timeline in order to fully respond to the final set of questions from the Agency to support the optimal label in the E.U. AMAG currently expects a decision from the Committee for Medicinal Products for Human Use (CHMP) in the first half of 2012.-- In Canada, the regulatory application for Feraheme for the treatment of IDA in CKD patients was approved in December 2011, and Feraheme is expected to be launched in Canada in 2012.-- Feraheme commercial launch in Canada and approval and commercial launch in Europe would trigger $33 million in milestone payments from Takeda.AMAG is seeking to expand the U.S. label for Feraheme to all adult patients with iron deficiency anemia regardless of the underlying cause through a 1,400 patient global registrational program. The broad IDA program, which is more than 98 percent enrolled, consists of two phase III studies, one comparing treatment with Feraheme to placebo, and the other comparing treatment with Feraheme to treatment with intravenous iron sucrose. The company plans to complete enrollment in this program this month and submit an sNDA to the U.S. Food and Drug Administration in the second half of 2012.

Presidio Pharmaceuticals Reports Progress with Hepatitis C Antiviral Programs

2012-01-10T23:12:00.000-08:00

Presidio Pharmaceuticals, Inc. announced today the successful completion of a Phase 1a dose-ranging assessment of PPI-668, a potent, pan-genotypic second-generation hepatitis C virus (HCV) NS5A inhibitor, in healthy volunteers and subsequent advancement to a Phase 1b assessment of the dose-related efficacy in hepatitis C patients.The Phase 1a dose-ranging assessment of PPI-668 was conducted with 32 healthy volunteers in New Zealand. The trial was a randomized, double-blind, placebo-controlled assessment of the safety and pharmacokinetics of three oral doses of PPI-668, initially assessed as single doses and subsequently as a multi-day regimen, in which the highest PPI-668 dose was given once daily for five successive days. The trial results indicated that all dose regimens of PPI-668 were well-tolerated. There were no serious or severe clinical adverse events, no patterns of treatment-related adverse events or laboratory abnormalities, and all subjects completed the trial successfully.Pharmacokinetic (PK) analyses of subjects' plasma samples in the Phase 1a trial indicated that substantial blood levels of PPI-668 were rapidly and consistently achieved and dose proportional. PPI-668 plasma concentrations were orders of magnitude above those shown to inhibit HCV replication in vitro and were maintained at predicted effective concentrations for more than 24 hours. These PK results support once-daily dosing for PPI-668 in future studies. Also important was the observation that in the 5-day multi-dose regimen, steady-state PK was achieved rapidly (by Day 2), with no evidence of subsequent accumulation or changes in the clearance profile of PPI-668."These first clinical data for PPI-668 indicate excellent tolerance in healthy subjects for up to five days," said Nathaniel A. Brown, M.D., Presidio's Chief Medical Officer. "Equally important, the pharmacokinetic profile of PPI-668 is very encouraging, suggesting that effective plasma concentrations can be obtained with relatively low, once-daily doses of PPI-668 - which will facilitate co-formulation of PPI-668 with other HCV antivirals in future combination therapies for hepatitis C."Patient screening for the Phase 1b evaluation of PPI-668 in hepatitis C patients has begun in New Zealand and the United States and will soon include Australia. Dosing of the first cohort of hepatitis C patients will begin this week. Presidio expects to have results regarding the antiviral efficacy of PPI-668 in HCV patients in the second quarter of 2012.In a second HCV research program focused on inhibitors of the HCV NS5B polymerase, Presidio has discovered a lead chemical series of non-nucleosidic NS5B inhibitors with potent activity against all major HCV genotypes. Preclinical profiling is ongoing with a goal of nominating a candidate for clinical development in the coming months.With its novel NS5A and NS5B inhibitors, Presidio's objective is to provide two complementary HCV antivirals that will be appropriate for broad use in optimized future combination therapies for patients with HCV infection. Presidio anticipates that such therapies will have a convenient oral dosing regimen (once or twice daily), will exhibit rapid pan-genotypic efficacy and will be well-tolerated.

Pacira Pharmaceuticals, Inc. Provides Update on Commercial Launch and Product Availability Timing for EXPAREL(R)

2012-01-10T23:10:00.000-08:00

Pacira Pharmaceuticals, Inc. today provided updated timing for its commercial launch of EXPAREL(R) (bupivacaine liposome injectable suspension), a non-opioid analgesic that was approved by the U.S. Food and Drug Administration (FDA) for administration into the surgical site to produce postsurgical analgesia.Since FDA approval of EXPAREL in October 2011, Pacira has continued to execute its pre-commercial launch strategy focused on the broad hospital market and has undertaken initiatives to expand and enhance its ability to efficiently manufacture commercial quantities of EXPAREL.As planned, Pacira has hired and trained a sales force and will proceed with a formulary-access driven launch strategy, beginning with a national sales meeting this week. Due to commercial manufacturing challenges, which Pacira is confident it can address, the company projects product availability in April 2012, by which time Pacira expects it will have manufactured sufficient product to meet customer demands at launch."Our goal is to ensure that we have an appropriate commercial supply of EXPAREL to support anticipated demand for the product following our launch," said Dave Stack, president and chief executive officer of Pacira. "We are encouraged by the positive response we have received following FDA approval of EXPAREL and our organization is focused on our commercial manufacturing processes. With the recent appointment of John Pratt to the newly created role of general manager for our San Diego manufacturing facility, we believe we have added leadership who will directly contribute to our ability to meet our goals. John has more than 35 years of experience in building and leading state-of-the art pharmaceutical manufacturing and quality control organizations including senior positions at Amylin and Novo Nordisk, and his expertise will be valuable as we execute our manufacturing strategy. We are very excited about EXPAREL and the role it can play in optimizing postsurgical pain management and look forward to bringing this product to the market."

Lotus Pharmaceuticals Announces Business Reorganization and Provides Updates on the Beijing Headquarters Building

2012-01-05T01:27:00.001-08:00

Lotus Pharmaceuticals, Inc. LTUS 0.00% ("Lotus" or the "Company"), a profitable developer, manufacturer and seller of medicine and drugs in the People's Republic of China ("PRC"), today announced it entered into an agreement to dispose its Inner Mongolia branch company, including land use right for the 1000 Mu (approximately 165 acre) land in Inner Mongolia, in order to focus its business on the Beijing wholesale market.Pursuant to the agreement with Meng Xin Vegetable Product Company (Meng Xin), the previous owner of the land use right for this tract of land, Lotus Pharmaceuticals will transfer ownership of Liang Fang Pharmaceutical, Ltd. Inner Mongolia branch company and certain assets and liabilities to Meng Xin. The assets, valued at approximately $52.6 million (based on RMB6.298/$), include the entire 1000 Mu land and building thereon (valued at approximately $44.5 million), approximately $7.3 million of account receivables, and three retail drug stores in Beijing (Feng Tai store, Yong An Zhong Sheng store, and He Ping Li store). The liabilities, also valued at approximately $52.6 million, include all tax payable and late payment fees, land use taxes and compensation to farmers which are collected retroactively, unpaid utilities and sewage, as well as management fees to the local government. Meng Xin will receive the assets and assume the liabilities after the transaction. There is no cash payment between Lotus and Meng Xin.Chairman and Chief Executive Officer Mr. Zhongyi Liu stated, "Because we have not undertaken development of the 1000 Mu land in Inner Mongolia as stipulated in the original agreement when we made the purchase in 2008, we are subject to some significant taxes and penalties, which are collected retroactively. As a result, we could not afford to hold the land any more. In addition, our decision to dispose of the Inner Mongolia branch and the 1000 Mu land is based on our strategic decision to focus on the Beijing wholesale market once the headquarters building is put into use. The transaction enables us to reduce current liabilities, which is very important to us as our resources are currently tied to the operation of the new headquarters building in Beijing."Separately, the Company started moving into its new headquarters building in Beijing's Chaoyang district at the end of December 2011. This over 34,000 square meter multi-story building will host the Company's key divisions, including manufacturing, R&D, sales and marketing, storage warehouse, and administrative offices. The Company expects the new storage warehouse to become functional by March 2012.Mr. Liu commented, "We expect the storage warehouse in the new headquarters building will be put into use by March, and the manufacturing facility by the end of Q3 of 2012, after inspection and certification are completed. With these new facilities, we anticipate additional capacity for growth and significant efficiency improvements in the coming years."

Cubist Pharmaceuticals and The New England Patriots Radio Network Honor Merrimack, New Hampshire, Science Teacher

2012-01-05T01:24:00.001-08:00

Cubist Pharmaceuticals, Inc. today announced that in partnership with The New England Patriots Radio Network, 98.5 The Sports Hub, it has selected Sean Muller, a science teacher at Merrimack High School, in Merrimack, New Hampshire, to receive the Cubist Pharmaceuticals Science Education Leadership Award. This award culminates Cubist and the New England Patriots Radio Network's recognition during the course of the football season of nine "Teachers of the Week", who are innovative science teachers in middle schools and high schools throughout New England. Mr. Muller was chosen from that group and was recognized at the New England Patriots game on January 1st.As part of Mr. Muller's award, Cubist will present the Merrimack High School science department with a $5000.00 check after the football season, along with a visit from a Patriots alumnus player and a representative from Cubist.Mr. Muller received several nominations, one in particular capturing the spirit of the Science Education Leadership Award: "Mr. Muller was my honors chemistry teacher four years ago. I am now in my junior year at the University of Connecticut studying Material Science Engineering, which is the study of different materials and why they exhibit certain mechanical characteristics, which can be used to create new materials. As you can imagine, most of my courses are a mix between physics and chemistry. Even now, I find myself using different tools and tricks that Mr. Muller taught me. Mr. Muller is a creative and engaging teacher who can spark the interest of many different students. "Throughout the season, Cubist and the New England Patriots Radio Network have recognized science teachers leading the way in the classroom. During the New England Patriots season, teachers were selected as the Cubist Pharmaceuticals "Teacher of the Week" and announced during the New England Patriots radio broadcast. In addition to Mr. Muller, the weekly qualifiers were Jason Tower (Wachusett Regional High School, Lianne O'Hara (Rumney Marsh Academy), Peter Nichol (Concord Carlisle High School), Jessica Digianfelice (Peabody Veterans' Memorial High School), Beth St. George (Hopkinton High School), Tim Maguire (Hopedale High School), Nancy Gifford (Harwich Middle School), and Shawlette Howard-Smith (South Lawrence East Middle School).Cubist Executive Vice President of Research & Development and Chief Scientific Officer Steven C. Gilman, Ph.D., said, "Mr. Muller is an outstanding example of leadership in science education. Science education must be a priority for society to prosper, and I was gratified to read in this year's nominations of the many dedicated science teachers innovating in the classroom, creating interest in students at the middle- and high-school level, and motivating them to pursue careers in science. Needless to say, all of the nominees and teachers who are demonstrating leadership and innovation in the classroom on a daily basis deserve our collective support for all they are doing to prepare the next generation for challenging jobs in science and technology and in other fields of endeavor."

Kedem Pharmaceuticals Engages a FDA Compliant Contract Formulation Development Company for the Production of KDM-1102 Clinical Materials

2012-01-05T01:22:00.000-08:00

Kedem Pharmaceuticals Inc. , a specialty pharmaceutical company with focus on sublingual drug delivery is pleased to announce that it has signed a contract with a GMP pharmaceutical FDA compliant formulation development company, Corealis Pharma, Inc. for the production of the phase I clinical supplies of KDM-1102, the Company's second lead therapeutic drug. The KDM-1102 drug is a new sublingual formulation of propanolol. The formulation development of the KDM-1102 drug is now completed and can be produce in large volume. "We are pleased with the progress we have been making in our development program on KDM-1102, our Second lead therapeutic drug for cardiovascular and anxiety attacks," said Dr. Hassan Salari, Kedem Pharmaceuticals, President & CEO.

US-China Pharmaceutical Venture Ascletis Receives Record-Level Research and Development Grant from Hangzhou

2012-01-05T01:18:00.000-08:00

China joint venture pharmaceutical company, today announced it has received a record level research and development grant from Hangzhou National Hi-Tech Industrial Development Zone (HHTZ) under that organization's "5050 Plan." The 10 million RMB grant (approximately US$1.6 million) is the largest startup company grant in the history of the 5050 Plan, whose goal is to incentivize and assist start-up, technology-based companies within HHTZ, Hangzhou, Zhejiang Province."This grant recognizes the outstanding opportunity offered by Ascletis to create a world-class pharmaceutical company in Hangzhou that will develop innovative products both for China and for the rest of the world," said Sheng Kong-Liang, Director of Organization of HHTZ. "Ascletis has made rapid progress in R&D since its formation in early 2011. Not only have they raised a $100 million Series A financing from private investors, but they have assembled a world class team of globally experienced pharmaceutical developers.""We are grateful for this recognition and support from HHTZ," said Jinzi J. Wu, Ph.D., Ascletis' President and Chief Executive Officer. "With such local governmental partners providing strong support to Ascletis' business, as well as our collaborators in Research Triangle Park, North Carolina, we are well positioned to address the large market potential that exists for innovative drugs, both in China and globally."

EXP Pharmaceutical Services Corp. and Capital Inventory, Inc. Announce Partnership to Immediately Make Available the Industry's Finest Pharmacy Physic

2012-01-05T01:14:00.000-08:00

EXP Pharmaceutical Services Corp., the nation's best-in-class provider of pharmacy services, announces a strategic partnership with Capital Inventory, Inc., the nation's premier hospital pharmacy inventory services company.The EXP-Capital Inventory partnership stems from both companies' recognition of the industry's need for an effective solution that will allow hospitals to secure the gold-standard third-party audit of physical pharmaceutical inventory."EXP has seen the increasing need among our hospital customers for wall-to-wall physical pharmacy inventory service excellence. Capital Inventory addresses that need; and we are very excited to offer a solution that will empower our clients to secure and rely on the highest quality of service, receive comprehensive reporting and obtain these from personnel who are the most experienced in hospital pharmacy inventories," said Gus Changaris, EXP's Chief Executive Officer.Through this partnership, EXP's clientele will be offered market-leading value and service. This inventory solution is performed by inventory specialists who are the most experienced in hospital pharmacy inventory service. "And that makes a significant difference throughout the total inventory experience. There are so many specifics unique to hospital pharmacies that true professionals, specializing in hospital pharmacy inventories only, offer substantial advantages," stated Kirk Herweck, Vice President, Business Development, Corporate Accounts and Marketing.EXP serves 70% of the U.S. hospital-based Reverse Distribution Market, represented by the many thousands of hospital customers. In addition to its well-established market dominance, EXP also has one of the most experienced regulatory-compliance staffs in the industry. EXP will actively offer and provide details of the Capital Inventory solution in each of its client consultations."EXP's market leadership is a key component to this partnership. Instantly, Capital Inventory's service is actively marketed in conjunction with EXP's service to over 70% of U.S. hospitals. We applaud EXP for taking a stand in delivering to their customers the premier provider for third-party inventory audits," said Duran Dunn, Capital Inventory's President.EXP and Capital Inventory offer the most experienced inventory staff in the industry with the average team leader possessing over 10 years of experience in hospital pharmacies which is critical when considering pricing, package sizes, pharmacy layout, pharmacy processes, dispensing automation and pharmacy staff.

Dicerna Pharmaceuticals Appoints Life Sciences Executive James B. Weissman to Chief Business Officer

2012-01-05T01:12:00.000-08:00

Dicerna Pharmaceuticals, Inc. (Dicerna), a second generation RNA interference (RNAi) company developing novel therapeutics utilizing its proprietary Dicer Substrate Technology(TM) and Dicer Substrate siRNA (DsiRNA) molecules, today announced the appointment of James B. Weissman to chief business officer. Mr. Weissman joins Dicerna with more than 25 years in the life sciences industry and will be responsible for corporate development, strategy and other operational functions."We are pleased to welcome Jim to Dicerna's management team," said Douglas M. Fambrough, Ph.D., chief executive officer of Dicerna. "Jim is a seasoned pharmaceutical executive with a proven skill set in business development, marketing, product development and strategic planning. We look forward to leveraging his unique expertise as we continue to innovate and accelerate our business development and partnering strategy focused on our Dicer Substrate Technology."Mr. Weissman is a life sciences executive with extensive international management experience in biotech and pharmaceutical general management, product development, licensing, business development, marketing and M&A activities. He joins Dicerna from MannKind Corporation MNKD -6.35% , where he was vice president of business development, responsible for leading the company's activities related to licensing, new products and strategic planning. Prior to MannKind, Mr. Weissman held leadership positions in both business development and marketing at Pfizer Pharmaceuticals, Inc. in Tokyo, most recently as senior director of marketing. In this position, Mr. Weissman was responsible for the sales, profit and strategic targets for the company's specialty products, including CNS, endocrinology, ophthalmology, oncology and diversified portfolios. Mr. Weissman holds a Bachelor of Science from Bates College in Maine."There continues to be strong interest and progress in the research and development of RNAi therapies, and Dicerna's Dicer Substrate Technology provides differentiation and offers significant advantages over other RNAi approaches," said Mr. Weissman. "I look forward to helping Dicerna continue to execute on its business strategy and further the research and development efforts utilizing the company's unique platform."

European Patent Office Upholds Synergy Pharmaceuticals' Grant of Claims to Plecanatide

2012-01-05T00:55:00.000-08:00

Synergy Pharmaceuticals, Inc. a developer of new drugs to treat gastrointestinal disorders and diseases, announced today the successful outcome of the Oral Hearing held December 14, 2011 before the Opposition Division of the European Patent Office regarding Synergy's granted patent on plecanatide. Synergy's European Patent EP 1 379 224 was originally opposed in May 2010 by Ironwood Pharmaceuticals IRWD +2.50% and another party. At the Oral Hearing, attended by Synergy and Ironwood representatives, the Opposition Division maintained Synergy's patent, in amended form. Specifically, The Opposition Division upheld the validity of the claims in Synergy's EP patent that relate to Synergy's lead drug candidate plecanatide. Written reasons consistent with the oral ruling are expected within a few months."We are pleased that the proceedings at the European Patent Office upheld the novelty and inventiveness of plecanatide," said Gary S. Jacob, Chief Executive Officer of Synergy.

Spectrum Pharmaceuticals to Present at the J. P. Morgan Healthcare Conference

2012-01-05T00:53:00.000-08:00

Spectrum Pharmaceuticals (nasdaqgs:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today that an overview of the Company's business strategy will be given at the 30th Annual J. P. Morgan Healthcare Conference, being held at the Westin St. Francis Hotel in San Francisco, California. The Spectrum Pharmaceuticals presentation is at 11 am Pacific Time on Thursday, January 12, 2012 in the California East room.

Teva hires BMS' Levin in quest for bigger share of pharmaceuticals market

2012-01-05T00:48:00.000-08:00

Phillip Frost wants a bigger bite of the global drug market for Teva Pharmaceutical Industries, which is why the board chairman and other directors hired Jeremy Levin to be the next chief executive officer of the world's largest generic manufacturer.Levin leaves Bristol-Myers Squibb, where he helped engineer the company's "string-of-pearls strategy," in which it forged successful partnership and licensing agreements with other companies.In choosing a doctor with a scientific and dealmaking background, Frost said, the Teva board wants to profit more from its move into different areas, including more branded drugs and over-the-counter products through a marketing deal with Procter & Gamble, while squeezing more out of its long-held global lead in the generic-drug market.

Drug company moving Halifax centre to Moncton

2011-12-29T00:38:00.000-08:00

McKesson Canada is moving its Halifax distribution centre to Moncton next month, citing that city’s more centralized location as an advantage.The Montreal-based national pharmaceutical company now has three distribution centres in Atlantic Canada — St. John’s, N.L., Moncton and its facility in Lakeside Industrial Park, just west of downtown Halifax.However, the company will consolidate its Moncton and Halifax centres and move them into a new 167,000-square-feet facility in Moncton’s Caledonia Industrial Park on Jan. 29.The company’s Atlantic Canada regional office, also at the Lakeside location, will be moving to Moncton as well.The consolidation was a “business decision,” company spokesman David Bone said via an email from Montreal.“Our Moncton distribution centre was no longer able to meet our needs in terms of space.”The decision to consolidate was made “after a thorough review of all possibilities, including availability of suitable properties, and taking into account our operational needs,” he added.“This will enable us to service our customers in a more efficient manner while meeting evolving operating compliance measures. We believe it will be more efficient to serve our customers in the Maritimes from a single distribution centre, and based on our review of all possibilities, Moncton appeared to be a convenient central location in the context of our current and future business initiatives.”Bone said that activities at the Halifax distribution centre will be transferred in stages to “ensure a smooth transition.” Offices will be transferred at the end of January 2012; the warehouse will be transferred at end of February 2012.The move will affect about 50 people who work at the Halifax centre. Some positions will be transferred to Moncton, but Bone did not have an exact number of people.“We are committed to treating each impacted employee with great consideration, in accordance with our shared principles of respect and fairness, and we will work closely with them throughout this transition.”

Bearish Moving Average Cross by Endo Pharmaceuticals (ENDP)

2011-12-29T00:36:00.000-08:00

Today, shares of Endo Pharmaceuticals (NASDAQ:ENDP) have fallen below their 10-day MA of $34.79 on a volume of 173K shares. This may provide swing traders with an opportunity for a short position, as such a crossover often suggests lower prices in the near term.Endo Pharmaceuticals Holdings Inc. is a specialty pharmaceutical company with products that provide pain management. The Company researches, develops, produces, and markets both branded and generic pharmaceuticals. Endo's products include Percocet, Percodan, and Lidoderm.Over the past year, Endo Pharmaceuticals has traded in a range of $26.02 to $44.53 and is now at $34.39, 32% above that low. In the last five trading sessions, the 50-day moving average (MA) has climbed 0.7% while the 200-day MA has remained constant.There is potential upside of 30.1% for shares of Endo Pharmaceuticals based on a current price of $34.39 and an average consensus analyst price target of $44.73. The stock should find resistance at its 200-day moving average (MA) of $35.34, as well as support at its 50-day MA of $32.74.

Watson Pharmaceuticals Bearish Moving Average Crossover Alert (WPI)

2011-12-29T00:35:00.000-08:00

Watson Pharmaceuticals (NYSE:WPI) crossed under its 10-day moving average of $60.95 on a volume of 319K shares. Swing traders may find an opportunity for a short position, as such a crossover often suggests lower prices in the near term.Watson Pharmaceuticals share prices have moved between a 52-week high of $73.35 and a 52-week low of $50.47 and are now trading 20% above that low price at $60.43 per share. Over the past week, the 200-day moving average (MA) has remained constant while the 50-day MA has declined 0.4%.Potential upside of 26.6% exists for Watson Pharmaceuticals, based on a current level of $60.43 and analysts' average consensus price target of $76.53. The stock should find initial resistance at its 200-day moving average (MA) of $64.19 and further resistance at its 50-day MA of $64.71.Watson Pharmaceuticals, Inc. develops, manufactures, and sells generic and brand name pharmaceutical products. The Company's core focus is specialty products, nephrology, urology, and generic products.

US HOT STOCKS: Tesoro, Medicis Pharmaceutical, Arctic Cat

2011-12-29T00:33:00.000-08:00

U.S. stocks traded lower Wednesday as the Dow Jones Industrial Average recently lost 1% to 12165, the Standard & Poor's 500-stock index shed 1.1% to 1251, and the Nasdaq Composite index declined 1.1% to 2595. Among the companies whose shares were actively trading in the session are Tesoro Corp. (TSO), Medicis Pharmaceutical Corp. (MRX) and Arctic Cat Inc. (ACAT).Crude-oil futures edged lower in thin volume as traders awaited more clarity on possible Iranian sanctions and further news on Europe's sovereign debt crisis. That weighed on energy stocks, with Alpha Natural Resources Inc. (ANR, $19.61, -$0.53, -2.63%), Nabors Industries Ltd. ...