USFDA Seized Illegal Prescription Drugs Supplied From Online Sources.

The U.S. Food and Drug Administration cracked down this week on illegal online websites that market potentially dangerous, unlicensed prescription drugs to U.S. consumers. The crackdown took place in support of the 7th annual International Internet Week of Action (IIWA) under the INTERPOL-sponsored Operation Pangea VII.

Together with the U.S. Customs and Border Protection (CBP), the FDA examined U.S. based international mail facilities and seized illegal prescription drugs supplied from online sources. A total of 19, 618 packages containing drugs presumably from Australia, UK, Canada, and New Zealand were seized. Further inspection revealed that the packages contained unapproved or possible counterfeit drugs from India, China, Mexico, Australia, and New Zealand, among others.

Inspection of mail facilities in Los Angeles, New York, and Chicago resulted in the detention or seizure of 583 packages. These contained insulin, estrogen, human chorionic gonadotropin, and sildenafil citrate, among others. The FDA notified Internet service providers and domain name registrars about the nearly 2,000 websites selling pharmaceutical products in violation of the U.S. law.

Douglas Stearn, director of the FDA’s Office of Enforcement and Import Operations, said, “When consumers buy prescription drugs from outside the legitimate supply chain, they cannot know if the medicines they receive are counterfeit or even if they contain the right active ingredient in the proper dosages. Consumers have little or no legal recourse if they experience a reaction to the unregulated medication or if they receive no therapeutic benefit at all.” Stearn added that these online illegal pharmacies can also lead to credit card fraud, digital viruses, or identity theft.

“Many illegal online pharmacies use slick website templates and empty guarantees to convince U.S. consumers that the inexpensive drugs they sell are the exact same prescription drugs that are dispensed in the U.S. The FDA will continue to leverage our resources and strengthen our national and international partnerships to shed light on these Internet-based fraudulent activities which target consumers,” said Philip J. Walsky, acting director of the FDA‘s Office of Criminal Investigations.

The FDA Takes Control Of E-Cigarettes

The Food and Drug Administration (FDA) is expected to issue rules on electronic cigarettes, also called e-cigarettes or e-cigs. “The FDA intends to propose a regulation,” said Jenny Haliski, press officer for the FDA, “that would extend the agency’s ‘tobacco-product’ authorities.” Currently, the FDA controls tobacco but not tobacco products like e-cigarettes.

E-cigarettes dispense nicotine in vapor form. They look like a cigarette but have a rechargeable heating element and a replaceable nicotine cartridge. An atomizer, when heated, converts the nicotine and other chemicals in the cartridge into a vapor. Proponents of the device say that the vapor is less harmful to the lungs than smoke from a real cigarette.

FDA Actions

In 2010, the FDA evaluated some types of e-cigarettes and found quality issues. Some brands misrepresented the amount of nicotine in each vapor puff. The agency issued letters to five distributors, warning them about substandard manufacturing and unsubstantiated claims. Since then, most states have urged the FDA to do more by regulating e-cigs like they do tobacco. The FDA has enlisted the support of the White House’s Office of Information and Regulatory Affairs and the Office of Management and Budget in reviewing the draft FDA rules.

Widespread Support for Rules

The U.S. Congress is working on creating laws for the booming industry. Congress seeks to regulate sales, impose taxes, and control advertising, especially to minors. State legislatures are also examining their options. Some states have already passed bills controlling sales and advertising to minors. U.S. agencies and legislatures join global efforts in regulating e-cigarettes. The European Union (EU) is also addressing the situation, with 28 governments of the EU considering banning them altogether. The tobacco industry is opposed to bans and restrictions.

Approved Smoking Cessation Aids

People who want to quit smoking have FDA-approved products to choose from. Oral products are nicotine gum and lozenges. People can use nicotine skin patches or nicotine nasal spray. Oral medications indicated for smoking cessation and approved by the FDA include Chantix (varenicline tartrate) and Zyban (buproprion). Neither drug contains nicotine and are available by prescription only. Both drugs carry warning labels citing possible side effects of mood fluctuations, hostility, and suicidal thoughts and actions.

FDA Issues Warning Against Sodium Phosphate Drugs

The FDA issued a safety warning to the public on January 9, 2014 addressing the safety concerns they have regarding over-the-counter sodium phosphate drugs, which are used to treat constipation. According to the FDA website, using more than one directional dosage of these medications over the course of 24-hours, can lead to serious health risks including harm to the heart and kidneys, and could even lead to death. Taking a higher dose than the recommended amount may produce the same results, even if taken once a day.

In addition, the FDA safety communication advises caregivers that oral sodium phosphate drugs are not suitable for children ages 5 or under, unless approved by a healthcare professional. The communication also advised healthcare professionals to proceed with caution and consider all risks when prescribing or recommending such drugs for children under the age of 5. The FDA advised that the use of rectally introduced sodium phosphate drugs should not be used for children under the age of 2.

According to the FDA, the administration was prompted to issue the warning on their website due to previous reports of severe dehydration and unintentional changes the drug caused to serum electrolytes, which occurred when the drug was taken more than once in a 24-hour period. The affected serum electrolytes include calcium, sodium, and phosphate.

In addition, individuals over the age of 55 are at risk of developing adverse effects to the drugs. Individuals who are dehydrated or experiencing symptoms of dehydration are not advised to use the drug along with those suffering from kidney disease, bowel obstruction or inflammation.

Finally, anyone taking medications that may affect kidney function are also advised to refrain from using over-the-counter sodium phosphate drugs. These medications include diuretics, water pills, ACE inhibitors, angiotensin receptor blockers and non-steroidal anti-inflammatory drugs like aspirin, ibuprofen, and naproxen.

Drug shortages play role in growth at West Pharmaceutical

Drug shortages usually stem from plant closures and can only mean bad news for patients and for whichever manufacturer is the target of FDA concerns. But for some companies those problems can mean more business, and supplier West Pharmaceutical Services ($WST) has been one such beneficiary. 

In reporting higher sales and earnings for its fourth quarter, the Exton, PA, company said that demand was fueled by customers who were working to "relieve market shortages of certain critical injectable drugs" and those who were building their inventories because of "more conservative risk management strategies." That helped West, which makes packaging and drug-delivery systems, to increase sales nearly 9%. It said it expects to grow revenue by 6% to 8% next year. 

With demand growing, the company is building new plants, expanding in emerging markets. It has wrapped construction of a packaging plant in China that should be pushing out product in the second quarter of this year. It also has started on its first packaging plant in India, which kicks off a 10-year plan to expand there. The India complex in Sri City, India, will eventually grow to 37,700 square meters. The plant will put West closer to customers who are themselves building expanding manufacturing in the region, and so cut lead times and costs.

Warwick Bedwell, West's president of pharmaceutical packaging systems in the Asia Pacific region, told FiercePharmaManufacturing when the plant was announced that besides demand from India and China, it is getting more orders from clients in South Korea and Australia with its biotech base. It expects growth in Indonesia and Vietnam to keep the momentum growing. "Western pharmaceutical multinationals are moving their production to Asia to satisfy the local demand, but local players are also looking for new opportunities across Asia and in the United States and Europe," Bedwell said.

USP, FDA update quality standards for common drugs

The U.S. Pharmacopeial Convention is working with the FDA and the Consumer Healthcare Products Association to update the quality standards for common medicines. It's part of a USP plan to assess drug data in the USP and National Formulary compendia, with an eye toward updating test procedures to keep pace with technology. On the common-medication list is acetaminophen, among the highest-volume OTC drugs and also used in prescription meds.

The FDA has recommended a test for impurities and degradants in products containing the ingredient.

USP teaming with FDA and CHPA to apply modern test methods to acetaminophen, other common

As part of its ongoing mission to protect public health, the U.S. Pharmacopeial Convention (USP) is working with the Food and Drug Administration (FDA) and the Consumer Healthcare Products Association (CHPA) to update quality standards for widely used medicines and ingredients. Several years ago, USP put in place an ambitious, long-term effort to assess written (or documentary) standards for prescription and over-the-counter (OTC) drugs published in the United States Pharmacopeia and National Formulary (USP-NF) compendia, aimed at stepping up the pace of revising test procedures where needed to reflect scientific advances. Coupled with this is USP's ongoing commitment to make available official USP Reference Standards (physical samples) for procedures described in documentary standards.

The working relationships with FDA and CHPA fit into that overall initiative, focusing on an initial list of priority medicines and ingredients identified by FDA. The USP-NF provides specifications for the identity, as well as quality, purity and strength of drugs and their ingredients, which are enforceable by FDA in the United States. USP standards are used in more than 130 countries.

FDA Commissioner Margaret Hamburg, M.D., expressed support for USP's standards modernization project during her remarks at the USP Convention meeting in April of 2010, citing this effort as one of the most pressing tasks facing both USP and FDA given documented incidents of poor-quality prescription and OTC products. Updated test methodologies are crucial to help counter economically motivated adulteration (in which less expensive and potentially harmful ingredients are substituted for genuine medicines or their ingredients), and also to address the challenge of impurities that may go undetected with older, non-specific assays and tests.

"FDA and USP have a long-standing partnership in law that helps ensure the quality of the American drug supply," said Roger L. Williams, M.D., USP's chief executive officer. "In the current effort, we are pleased to be joined by CHPA as well, as this initiative would not be possible without the active participation of industry. FDA has identified a number of medications and ingredients commonly used in prescription and OTC products that may be vulnerable to economically motivated adulteration or are associated with other concerns, which has helped focus our efforts. USP is working to make sure the quality standards for these products are based on the best current analytical procedures and allied reference materials to resolve such concerns. American patients, consumers and practitioners have a right to expect this."

In addition to the first list of products and ingredients for USP's priority attention, FDA will continue to recommend candidate standards for updating. An example of an FDA recommendation is a test for impurities and degradants in products containing acetaminophen-one of the highest-volume OTC drugs and one that is also used in many prescription medications. Other commonly used ingredients to be updated include dextromethorphan (a cough suppressant) and diphenhydramine (an antihistamine).

USP will consider all recommendations for updates through its well-established process, in which volunteer experts evaluate standards, solicit commentary from the stakeholder community and ultimately decide on changes to incorporate. USP invites and encourages all stakeholders to provide input into the modernization initiative, and is seeking comment from manufacturers of products and ingredients included in the priority list of standards to be updated-as well as from the practitioner and consumer advocate communities.

FDA's priority list and background information on the standards modernization initiative may be found at www.usp.org/hottopics/monographs.html. Also on this Web page, USP has issued a call for volunteer experts for the Acetaminophen Monograph Expert Panel, which will provide recommendations for revisions to the Expert Committee.

FDA accepts Handa Pharma generic Dexilant ANDA PBR Staff Writer

Handa Pharmaceuticals said that the US Food and Drug Administration has accepted its Abbreviated new drug application (ANDA) for Dexlansoprazole delayed release capsules, 60mg for review.

The company claims that Dexlansoprazole delayed release capsules is the generic version of Takeda's Dexilant which is indicated as a once-daily oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).

Handa Pharmaceuticals is a specialty pharmaceutical company established in the San Francisco Bay area in November 2005.

FDA chief defends handling of heparin, Momenta

The U.S. Food and Drug Administration had to act swiftly during a massive recall of the widely-used blood thinner heparin, but was not influenced by help from Momenta Pharmaceuticals Inc when it later approved one its drugs, the agency's chief told Reuters.

FDA Commissioner Margaret Hamburg's comments on Tuesday follows criticism from Republicans over the agency's handling of the heparin contamination in 2008, which stemmed from ingredients from China.

At the time, 81 people died from contaminated versions of the drug while many others experienced serious allergic reactions. The FDA, in trying to nail down the source of the problem, relied on volunteer help from Momenta scientists.

The FDA later approved Momenta's generic version of Sanofi-Aventis SA's blood thinner Lovenox, but rivals such as Teva Pharmaceutical Industries Ltd have complained that their versions were not cleared as well.

A government report, released on Tuesday, questioned the FDA's standards in accepting such outside help, saying the "risks could have affected the public's confidence" in responding to the heparin crisis and also left it vulnerable in other ways.

Bydureon (Exenatide) Once-Weekly Injectable Diabetes Drug Rebuffed By FDA Again

The bid to get Byetta(exenatide) once-weekly version for diabetes treatment approval from the FDA (Food and Drug Administration) has failed for a second time Amylin Pharmaceuticals, Inc., Eli Lilly and Alkermes, Inc. announced. The plan was to sell the once-weekly version of exenatide under the brand name Bydureon. In a response letter, the FDA explained that it wanted a comprehensive study on the medication's effect on QT interval at higher than normally given doses, it also wants to examine the DURATION-5 trials' efficacy, and the labeling of its safety and effectiveness - the trial compared exenatide's extended release formulation (Bydureon) to twice-daily injectable Byetta, which is currently available.

Eli Lilly said today that the iQT protocol will be worked out with the FDA before starting the study. It aims to submit a reply to the complete response letter by the end of next year. Experts in the pharmaceutical industry say that this "surprise"delay will probably make the three companies have another close look at their short-term strategies. Bydureon is an investigational, extended-release injectable drug for patients with diabetes type 2; it is designed to deliver continuous therapeutic levels of exenatide with just one dose per week. Byetta, which was approved in the USA in June 2005 as a twice-daily injection to improve glycemic control in diabetes type 2 patients, is also available in over 60 countries. Both brands belong to the glucagon-like peptide receptor agonist class of drugs.

Bydureon's New Drug Application (NDA) was submitted in May 2009. The submission is based on information included in the DURATION-1 clinical trial, a head-to-head study, as well as data on Byetta since it appeared on the market.

Over 24 million US citizens have been diagnosed with diabetes. The World Health Organization (WHO) estimates that approximately 285 million adults globally suffer from diabetes, of whom between 90% and 95% have diabetes type 2. CDC (Centers for Disease Control and Prevention) data indicates that the majority of people with diabetes do not attain their target blood sugar levels. 55% of individuals with diabetes type 2 are obese and 85% are overweight (including obese).

FDA rejects diabetes drug that includes Alkermes' delivery tech Read more: FDA rejects diabetes drug that includes Alkermes' delivery tech - FierceDr

The FDA's rejection Tuesday of the diabetes drug Bydureon is being reported as a big loss for all three companies with a stake in the once-a-week therapeutic driven by Alkermes' drug delivery technology. There will be a great deal of chatter today about how Eli Lilly, Amylin and Alkermes are big losers in Bydureon's second thumbs-down by the regulatory agency.The agency is asking the companies to come up with a new study looking at whether the drug could be connected to irregular heartbeats in patients. It's asking for a thorough study on what is called the QT interval, which is used to predict possible disruptions in rhythm. The FDA is worried that patients with impaired kidney functions, in combination with the Bydureon, could be candidates for heart attacks. So, it's back to the drawing board and the drug will likely not be back before the FDA until late 2011 or early 2012.

Mylan: generic blood pressure drugs approved

Mylan Inc. said Friday it received approval to start selling generic versions of Merck and Co.'s blood pressure drugs Cozaar and Hyzaar.

The drugmaker from Canonsburg, Pa., has now received marketing approval for several doses of the drugs, but it was not able to sell them until this month. Its competitor Teva Pharmaceutical Industries Ltd. was the first company to file for approval of generic versions of the drug, so other versions were barred from the market for six months. Teva received FDA clearance in April.

The newly approved versions of the drug are ready for shipping immediately, Mylan said.

Combined, Cozaar and Hyzaar were Merck's second best selling product. Mylan said U.S. sales of Cozaar totaled $940 million over the 12 months ended June 30, while Hyzaar sales totaled $570 million. Merck's sales fell by almost half after Teva started selling its generics.

Mylan shares rose 2 cents to $18.96 in morning trading Friday.

Author of ‘Sex, Lies and Pharmaceuticals’ Criticizes ‘Hypoactive Sexual Desire Disorder’

Is female sexual dysfunction a medical condition?

Drug companies have sure been trying to make you think so, says researcher and journalist Ray Moynihan in his new book, “Sex, Lies and Pharmaceuticals.” So far, though, their efforts to get anything approved by the FDA to treat hypoactive sexual desire disorder, to use industry lingo, have been for naught.

Most recently, Boehringer Ingelheim stopped the development of flibanserin, which was intended to boost sex drive in women and was originally studied as an antidepressant. An FDA advisory panel rejected the drug in June after the formal FDA review criticized data on the drug’s ability to increase libido. The German pharma company said the decision to cease development was “not made lightly,” and that it continues to believe in the benefits the drug “would have for women suffering with HSDD.”

“It’s quite significant that [Boehringer] abandoned that after so much hype,” Moynihan tells the Health Blog.

He and his co-author Barbara Mintzes argue in their book that HSDD is largely a creation of the pharma industry. They write that 1990s research claiming that about 43% of women suffer from the disorder sprang from a questionnaire that grouped all sexual desire issues together, without regard to severity, frequency or whether the source was emotional or physical.

Moynihan lambastes drug-industry-financed patient advocacy groups, medical associations and “key opinion leaders” for a global marketing strategy aimed at convincing doctors and regulators that female sexual dysfunction was a medical condition in need of a pharmaceutical treatment.

Doctors reviewing the manual that defines mental disorders and their appropriate treatment should reconsider whether HSDD is a medical condition at all, he says.

Jazz Pharma Loses Fibromyalgia Drug Approval, Still on our Top Pharmaceutical Stocks List

Drug maker Jazz Pharmaceuticals Inc. (NASDAQ: JAZZ) said it failed to get an FDA nod for its JZP-6 (sodium oxybate), a potential treatment for fibromyalgia. The U.S. health regulator, in its complete response letter, informed the Palo Alto, Calif.-based company that additional clinical studies of JZP-6 would be required and that the agency wanted more information on the appropriate fibromyalgia patient population, methods to ensure the drug’s safe use, dosage and a risk management plan.

Monday’s news did not come as a great surprise given that a joint advisory committee in August voted against the approval of JZP-6 amid risks of drug abuse and accidental overdose. JZP-6 is a close relative of gamma-hydroxybutyric acid (GHB), which has been used as a club drug.

Since 2002, Jazz has been selling JZP-6 as a treatment for sleep disorders under the brand name Xyrem. It also markets Luvox CR (fluvoxamine maleate) for the treatment of both obsessive-compulsive disorder and social anxiety disorder.

Jazz is focused on the development and commercialization of pharmaceutical products to meet unmet medical needs in neurology and psychiatry. Expanding its market to include fibromyalgia would be a significant growth opportunity for the drug maker. Fibromyalgia, one of the most common chronic pain conditions, affects an estimated 10 million people in the United States and an estimated 3-6% of the world population, according to the National Fibromyalgia Association.

Following Monday’s negative FDA decision, the company said it has requested a meeting with the FDA in order to discuss and clarify the contents of the complete response letter and will then evaluate its next steps for JZP-6.

“We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6 if it were approved by FDA,” Bruce Cozadd, chairman and CEO of Jazz stated in a press release.

So far JAZZ has reached a 52-week low and high of $6.01 and $13.95, respectively. It has a consensus recommendation of Outperform.

Valeant Pharmaceuticals Announces That Alexza Pharmaceuticals Has Received a Complete Response Letter for AZ-004 (Staccato® Loxapine) Inhalation Aeros

Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced today that Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Alexza's New Drug Application (NDA) for AZ-004 (Staccato® loxapine) submitted as Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg. Valeant's subsidiary, Biovail Laboratories International SRL (BLS), entered into a collaboration and license agreement with Alexza Pharmaceuticals, Inc. in February 2010 for the U.S. and Canadian rights to commercialize AZ-004. AZ-004 is being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

A CRL is issued by the FDA's Center of Drug Evaluation and Research indicating that the NDA review cycle is complete and that the application is not ready for approval. In the CRL received by Alexza, the FDA stated that their primary clinical safety concern was related to data from three Phase I pulmonary safety studies with AZ-004. This concern was based on observed, dose-related post-dose decreases in forced expiratory volume in one second, or FEV1, a standard measure of lung function, in healthy subjects, and in subjects with chronic obstructive pulmonary disease (COPD) and asthma. Alexza intends to meet with the FDA in the near future to discuss steps necessary to address this FDA concern. Alexza has previously reported that there were no serious or severe respiratory adverse events in these trials or reported in the two Phase III clinical trials of AZ-004. All respiratory symptoms that developed after treatment in Phase I subjects with COPD and asthma were either self-limiting or readily managed with an inhaled bronchodilator.

The CRL also raised issues relating to the suitability of the stability studies undertaken by Alexza and certain other items relating to the FDA's recently completed pre-approval manufacturing inspection. Because AZ-004 incorporates a novel delivery system, the CRL also included input from FDA's Center for Devices and Radiological Health (CDRH). CDRH requested a human factors study and related analysis to validate that the product can be used effectively in the proposed clinical setting. CDRH also requested further bench testing of the product under an additional "worst-case" manufacturing scenario.

FDA Rejects GHB for Fibromyalgia

The FDA has told Jazz Pharmaceutical it can't approve sodium oxybate (JZP-6), also known as GHB, in its current form for treating fibromyalgia.

The FDA listed a number of reasons for the decision, including the need for additional clinical studies, and the need for methods to ensure its "safe use," according to a company press release.

In August an FDA advisory panel voted 20-2 against approval of the drug for a fibromyalgia indication.

The Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee felt the potential for widespread abuse of the "date rape" drug was too great to warrant expanding the indication to a condition that affects an estimated 2% of the U.S. population.

Sodium oxybate, currently approved as Xyrem at a 500 mg/ml dose for narcolepsy-associated cataplexy and excessive daytime sleepiness, is a central nervous system depressant and carries a boxed warning against its use in combination with other similar drugs.

The label information also warns that sodium oxybate is a drug known to be abused. Sodium oxibate is a sodium salt of y-hydroxybutyrate, or GHB.

The committee examined the company's two randomized, double-blind, phase III trials testing sodium oxybate versus placebo.

In FDA documents released in advance of the August panel meeting, FDA reviewers said there was "no question" the drug was effective, but advisory committee members weren't so sure.

Also, panelists were concerned about the drug's odd dosing mechanism, as was the FDA. The drug has an extremely short half-life, so patients must take one dose of a self-mixed solution at bedtime, and set their alarm clocks to wake up and take a second dose four hours later.

Patients taking the drug pass out almost immediately, with no time to even "send an e-mail" as another patient put it.

The dosing apparatus also has the potential for confusion, panelists pointed out. Patients must empty a solution into a small cup and mix it with water. Several people in the study accidentally took a double dose.

GHB was sold without a prescription in health food stores until 1990 when it was classified as a controlled substance by the FDA.

Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals, said his company has requested a meeting with the FDA to discuss the agency's denial.

"We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6 if it were approved by FDA," Cozadd said in the press release.

FDA Warns Actelion Unit On Post-Marketing Drug Report Failures

The Food and Drug Administration said a U.S. unit of Swiss pharmaceutical company Actelion Ltd. (ATLN.VX) failed to follow the agency's post-marketing drug reporting requirements.

In a Sept. 14 warning letter, the FDA said Actelion Pharmaceuticals US Inc. failed to report about 3,500 patient deaths in connection with Tracleer and Ventavis--which are drugs approved to treat pulmonary arterial hypertension--"without an adequate basis for not reporting them." The letter was posted on the FDA's website Tuesday.

The FDA said that it wasn't concluding that the deaths were linked to the drugs, but that Actelion didn't follow proper procedures in determining if the deaths should be reported to the FDA and under which procedure.

In cases where a drug might play a role in a patient death, or in cases where companies don't have enough information to determine if a drug might have contributed, deaths must be reported to the FDA within 15 days. In other cases, deaths and side effects can be reported in annual periodic safety updates if information suggests the death is not drug-related.

"Actelion is responsible for ensuring that it has a system in place to keep FDA appropriately apprised of adverse events so that FDA can appropriately evaluate the safety of drugs in the post-market environment," the agency said.

An Actelion spokesman said the company was working with the FDA to resolve the matters raised in the letter.

Santarus and Cosmo Announce Positive Results in U.S. Phase III Study for Colitis drug

Specialty pharmaceutical companies Santarus (NASDAQ:SNTS) and Cosmo Pharmaceuticals (SIX:COPN) announced Thursday their positive results from the phase III clinical study of budesonide MMX for mild or moderate ulcerative colitis, a form of inflammatory bowel disease.

Ulcerative colitis produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements. It is believed that as many as 1.2 million people in the U.S. have IBD.

The disease is a chronic illness that relapses and then remits on and off again, and there is no known cure. However, up to 30% of patients with mild or moderate ulcerative colitis require add-on therapy to traditional treatment.

The phase III study, which was conducted in the U.S. and India to evaluate the safety and efficacy of the drug, showed that budesonide MMX, when taken once daily, met the primary endpoint by achieving clinical remission after eight weeks of treatment, as measured by the ulcerative colitis disease activity index. Using a dose of 9mg, 18% of patients taking the drug were in remission, versus slightly more than 7% in the placebo arm of the study.

The positive results are considered a step forward for the two companies toward the submission of a new drug application to the U.S. FDA. Results from the European phase III study are expected in November. Santarus and Cosmo Technologies, a subsidiary of Cosmo Pharmaceuticals, are collaborating on the phase III programs together.

"Assuming positive results in the European clinical study, we plan to submit the NDA in the second half of 2011 following the completion of an ongoing double-blind, placebo-controlled extended use study," said president and CEO of Santarus, Gerald T. Proehl.

The trial results also show that budesonide MMX was generally well tolerated, the company said.

The FDA has requested that the results from an additional 12-month extended use study be included in the Phase III clinical program to support a U.S. regulatory submission. The extended study of 123 patients taken from the phase III trials in the U.S., India and Europe will evaluate the long-term safety and tolerability of the drug, as well as collect data on its efficacy in maintaining the remission stage.

Budesonide MMX is a locally acting corticosteroid in an oral tablet formulation, which uses Cosmo's MMX multi-matrix system technology, designed for the controlled release and distribution of budesonide throughout the colon.

Italy-based Cosmo develops therapies for selected gastrointestinal and topically treated skin disorders. The company's pipeline specifically addresses treatments for IBD, such as ulcerative colitis and Crohn's disease, and colon infections.

Santarus is focused on acquiring, developing and commercializing products that address the needs of patients treated by specialists, including gastroenterologists, endocrinologists, allergists, immunologists and rheumatologists.

The company's current commercial efforts are focused on Glumetza and Cycloset, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. It expects to commercially launch Cycloset in November 2010.

Santarus also has a pipeline that includes rifamycin SV MMX, for treatment of travelers' diarrhea and Rhucin, for treatment of acute attacks of hereditary angioedema.

FDA to ban unapproved oral colchicine products

Shares in Hikma Pharmaceutical, a company that will be impacted by the move, closed down 4.2 percent at 688.5 pence, after earlier falling as much as 7.5 percent, after analysts cited the document.

Oral colchicine has been available since the nineteenth century, but was only approved by the FDA last year when it cleared Mutual Pharmaceutical's Colcrys product, which is based on the drug.

Several companies, but not Hikma, were asked to pull unapproved colchicine products earlier in the year.

Hikma kept its medicine, made by its generics division, on the market, helping boost its first-half sales in the United States by 41 percent.

The latest statement, visible here was due to be officially published on October 1 but will not come as a surprise to Hikma, which had said it expected growth in its U.S. generics division to slow to about 20 percent or more in the second half.

Numis analyst Jonathan Kwok said in a note on September 17 that much of Hikma's first-half earnings beat was down to colchicine, and he calculated that the firm recognized about $30 million of sales in the period, generating gross profits as high as $25 million.

"If the FDA follows its official guidance of a 'one year grace period', Hikma's colchicine is due to be pulled from the market any time now," he said in the September note.

Hikma said it had not been directly contacted by the FDA.

A spokeswoman said: "Hikma would of course comply if it receives a request or notification to stop selling colchicine."

FDA delays ruling on Teva version of Amgen drug

Teva Pharmaceutical Industries Ltd. said Thursday that U.S. regulators want more information on its version of Amgen Inc.'s drug Neupogen before granting marketing approval.

Teva, the world's biggest maker of generic drugs, asked the FDA to allow it to market the generic drug under the name Neutroval. Neupogen and Neutroval are intended to treat severe neutropenia, or a lack of white blood cells, in patients being treated for cancer.

The FDA, which sent Teva a letter asking for more information, will not require any new premarket trials to gain approval, the Israeli company said.

In afternoon trading, Teva's U.S.-traded shares rose 20 cents to $52.79. Amgen shares rose 3 cents to $54.97.

FDA reviews Actos over bladder cancer link

Regulators in the USA have begun a review of Takeda Pharmaceutical Co's diabetes blockbuster Actos amid fears of a link to bladder cancer.

The US Food and Drug Administration is reviewing Actos (pioglitazone), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of the $4 billion-a-year drug. Those findings are based on five-year data from an ongoing, 10-year observational study being carried out by the Japanese firm's Noth Amercian division.

The FDA noted that these early results "showed no overall association" but there was an increased risk of bladder cancer in patients with the longest exposure to Actos "and in those with the highest cumulative dose of the drug". The agency stresses that patients should not stop taking the drug unless told to do so by their doctors.

In preclinical carcinogenicity studies of pioglitazone, bladder tumours were observed in male rats receiving Actos that produced blood drug levels equivalent to those resulting from a clinical dose. Additionally, results from two, three-year controlled trials (the PROactive study and a liver safety study) "demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators," the agency added.

Takeda conducted a planned analysis of the study data at the five-year mark, which showed no statistically significant association between Actos and bladder cancer risk and the company says it will complete the trial as planned.

The FDA also noted that GlaxoSmithKline's Avandia (rosiglitazone), which like Actos belongs to the thiazolidinedione class of drugs, has not been associated with bladder cancer. The latter disease occurs in an estimated 20 per 100,000 people per year in the United States and is thought to be higher in diabetics, the agency added.

Arena's Diet Pill Lorcaserin Works by a `Slim Margin,' FDA Staff Says

Arena Pharmaceuticals Inc.’s experimental diet pill may cause cancer and works only by a ‘slim margin,’ U.S. regulators said, sending shares down the most ever.

The medicine, lorcaserin, was linked to “a number of malignant tumor types” in studies of rats, Food and Drug Administration staff said in a report released today. The drug helped people lose 3 percent more weight than a placebo, short of the recommended 5 percent, the agency said.

Arena and partner Eisai Co. are racing against Vivus Inc. and Orexigen Therapeutics Inc. to introduce new treatments for the one-third of Americans who are obese. Lorcaserin is similar to fenfluramine, a component in the diet pill fen-phen that was withdrawn from the U.S. market in 1997 because of links to heart-valve damage.

“The big surprise to us here is the cancer thing,” said Jon Lecroy, an analyst at Hapoalim Securities in New York, in a telephone interview today. “Knowing the drug doesn’t work that well, I knew the safety concerns would be looked at extremely closely.”

Shares Plunge

Arena fell $2.72, or 40 percent, to $4.13 at 4 p.m. New York time in Nasdaq Stock Market composite trading, their biggest decline since the stock began trading in July 2000. Before today, the San Diego-based company had almost doubled this year.

An FDA advisory panel will review the staff findings on Sept. 16 in Adelphi, Maryland, ahead of the agency’s scheduled decision on approval next month.

Lorcaserin is Arena’s first product and has the proposed brand name Lorqess. Peak global sales may reach $800 million in 2015 if the drug is approved, Lecroy said. Eisai bought rights to sell the drug on July 1 and plans to give about a third of the revenue to Arena.

According to FDA recommendations released in 2007, medical products designed for weight management should help at least 35 percent of people lose at least 5 percent of their weight and double the proportion of the placebo-treated group, or they should work 5 percent better than placebo. Lorcaserin only barely satisfied the first criteria, and didn’t meet the second, the agency said.

Didn’t Satisfy

“Lorcaserin did not satisfy the guidance’s mean efficacy criterion,” said Eric Colman, deputy director of the FDA’s Division of Metabolism and Endocrinology Products, in a memo to the advisory panel included in the staff report. The proposed ten milligram, twice-daily dose “did, by a slim margin, satisfy the categorical efficacy criterion.”

Two-thirds of American adults are overweight, raising their risk of diabetes, heart disease, high blood pressure and cancer, according to the 2008 National Health and Nutrition Examination Survey. More than one-third of American adults are obese, measured as a ratio between height and weight.

Lorcaserin binds to a receptor in the brain that controls appetite while avoiding a separate target thought to have contributed to irregular functioning of heart valves in about 30 percent of people who took Wyeth’s fen-phen.

Sales of prescription weight-loss drugs fell 11 percent last year to $153.7 million, according to the research firm IMS Health Inc. in Norwalk, Connecticut. Of the almost 7.5 million prescriptions dispensed, four of every five were for generic phentermine, a component of fen-phen still sold as a short-term appetite suppressant.

The last prescription diet pill approved by the FDA, Basel, Switzerland-based Roche Holding AG’s Xenical in 1999, has been linked to liver damage, and Abbott Park, Illinois-based Abbott Laboratories’ 13-year-old Meridia was tied to heart attacks, strokes and deaths in an FDA staff review yesterday.

The agency is scheduled to decide on lorcaserin by Oct. 22, Vivus’s Qnexa by Oct. 28, and Orexigen’s Contrave by Jan. 31. Orexigen, of San Diego, announced a licensing agreement with Osaka, Japan-based Takeda Pharmaceutical Co., Asia’s biggest drugmaker, on Sept. 2. Vivus, of Mountain View, California, failed to win the advisory panel’s backing for Qnexa in July.