Voveran 1ml causes Kidney Damage: Health Ministry Recommends Toxicity Check

Diclofenac injection is a painkiller which is manufactured by Themis Medicare Ltd and marketed by Novartis India under the brand name Voveran 1 ml Injection.

Troikaa Pharmaceuticals had alleged that the painkiller injection diclofenac Sodium 75 mg/ml contains Transcutol, which damages kidneys and filed a petition in Delhi High Court against the granting of manufacturing licenses for the painkiller and allowing its marketing by Novartis AG.

Troikaa has developed and sells Diclofenac Sodium 75 mg/ml injection under the brand name ‘Dynapar AQ’, which is patented globally.

The petition stated that Themis to avoid patent infringement, is manufacturing a different version of its Diclofenac Sodium 75 mg/ml injection and Novartis is marketing it.

The petition further stated that Themis and Novartis have conveniently ignored the fact that Transcutol P is not recommended for parenteral use Regulatory bodies in US, Europe, and other parts of the world do not permit it’s parenteral use, as it is known to cause injury to kidneys.

During the hearing, the court had formed an expert panel to review the safety of Transcutol-P who gave their recommendations in favor of Troikaa. Novartis then approached the health ministry after which the second panel was formed under the Directorate General of Health Services. The second panel gave their decision in favor of Novartis.

Another panel was formed under Girish Sahni, director general, Centre of Scientific and Industrial Research (CSIR), in May after the contradictory reports on Troikaa’s allegations.

The which submitted its report on 29 December, endorsed Troikaa’s submissions. The committee also did not find any evidence supporting the claim of Novartis and Themis, two people aware of the matter said, adding that the panel has recommended that Transcutol-P be independently tested for toxicity. 

Sahni panel, A spokesperson for Themis maintained that product is absolutely safe and told , “Post our meeting with the committee sometime in July 2017, we do not have any further status on the subject from authorities, hence unable to comment.”

Idenix Pharmaceuticals Employment Agreement With CFO Daniella Beckman

On June 20, 2011, Idenix Pharmaceuticals, Inc. entered into an employment letter with Daniella Beckman, age 32, who was appointed by the Company's board of directors to serve as Vice President, Chief Financial Officer and Treasurer of the Company, effective as of June 2, 2011, subject to the consent of Novartis Pharma AG.

Novartis Pharma AG provided its consent to the selection and appointment of Ms. Beckman as the Company's Vice President, Chief Financial Officer and Treasurer as required.Ms. Beckman served as the Company's interim Chief Financial Officer and Treasurer from October 2010 to June 2011. Ms. Beckman served as the Company's Corporate Controller from March 2008 to October 2010.

From March 2006 to March 2008, Ms. Beckman held positions at Coley Pharmaceutical Group, most recently as Corporate Controller. Prior to Coley, Ms. Beckman held positions at Biogen Idec from September 2004 through March 2006 as well as PricewaterhouseCoopers from September 2000 through 2004.

Ms. Beckman holds a B.A. from Boston University. She is also a Certified Public Accountant, or CPA.Pursuant to the Employment Letter, Ms. Beckman is entitled to receive an annual base salary in the amount of $240,000, which amount will be annually reviewed for increase, but not decrease, at the discretion of our board of directors. Ms. Beckman is also entitled to receive an annual cash performance bonus in a target amount equal to 35% of her base salary if, in the discretion of our board of directors, annually established performance criteria are satisfied.

For 2011, Ms. Beckman will be entitled to receive a cash bonus in a target amount equal to 20% of her pro rated base salary based on achievement of performance criteria for the period from January 1, 2011 to June 1, 2011 and, in accordance with the Employment Letter, 35% of her pro rated base salary from June 2, 2011 to December 31, 2011. In each case, the actual bonus may range from zero to 200% of the target amount.

On June 2, 2011, Ms. Beckman was granted options to purchase 50,000 shares of Idenix common stock, $0.001 par value per share (the "Common Stock") pursuant to the Idenix Pharmaceuticals, Inc. 2005 stock incentive plan, as amended. The stock options have an exercise per share equal to $4.57 per share, representing the average of the opening and closing price of our common stock on the date of grant, as reported by The NASDAQ National Market. The stock options will vest ratably over a 48 month period beginning on June 30, 2011. The Employment Letter further provides that Ms Beckman is eligible to participate in all benefit plans Idenix provides generally to its senior level executives and has the opportunity, subject to approval by the Company's board of directors, to be awarded annually stock options to purchase 85,000 shares of Common Stock on terms and conditions similar to the stock option awarded on June 2, 2011.

Ms. Beckman's employment is terminable by either Idenix or Ms. Beckman at any time. Subject to the next paragraph below, under the terms of the Employment Letter, if Ms. Beckman's employment is terminated by Idenix without cause or by Ms. Beckman for good reason (each as defined in the Employment Letter), subject to her execution of a release agreement within a specified period of time, all of her stock options to purchase Common Stock will immediately vest in full, and she will be entitled to receive: (i) a lump sum payment equal to one times (A) her annual base salary plus (B) the greater of her target bonus for such year or the actual bonus paid in the year immediately preceding the termination; and (ii) continuation of health and dental insurance benefits for twelve months.

If Ms. Beckman's employment is terminated by the Company or a successor entity without cause or by Ms. Beckman for good reason in each case within one year following a change in control of Idenix (as defined in the Employment Letter), subject to her execution of a release agreement within a specified period of time, all of her stock options to purchase Common Stock will immediately vest in full, and, in addition to the cash amounts set forth in the paragraph above, she will be entitled to receive: (i) a lump sum payment equal to one times (A) her annual base salary plus (B) the greater of her target bonus for such year or the actual bonus paid in the year immediately preceding the termination; and (ii) continuation of health and dental insurance benefits for twelve months.

The foregoing description of the Employment Letter is qualified in its entirety by the text of such letter which is filed herewith as Exhibit 10.1.

Novartis begins construction of new plant in St Petersburg, Russia

Novartis held a groundbreaking ceremony to announce the start of construction of a pharmaceutical manufacturing plant in St. Petersburg, Russia. The construction of this facility represents the most significant Novartis investment in Russia to date. This facility will further expand the company's capabilities to produce and deliver both innovative pharmaceuticals and high-quality generics to Russian patients.

The new greenfield facility will be built in the Novoorlovskaya Special Economic Zone (SEZ), located to the north of the St. Petersburg city centre. Once completed and approved for commercial production, which is expected in 2014, the state of-the-art facility will use cutting-edge technologies to produce approximately 1.5 billion units per year. It will also be an attractive workplace for local talent, employing more than 350 highly qualified professionals who will have access to world-class training and development programmes at Novartis.

“The establishment of the new Novartis manufacturing facility demonstrates our commitment to invest in the Russian healthcare infrastructure and to contribute to the long-term goals of improving healthcare in Russia, set by the government,” said Joseph Jimenez, CEO, Novartis AG. “The plant in St. Petersburg is the latest step in our strategy to bring both innovative pharmaceuticals and low cost, high quality generics closer to patients and customers in Russia.”

The groundbreaking ceremony was attended by Minister of Economic Development of the Russian Federation, E Nabiullina, Governor of St. Petersburg V Matvienko, Novartis AG CEO Joseph Jimenez and other Novartis collaborators and key representatives from the Russian government and the Swiss embassy.

“Novartis decision to launch drug production in Saint-Petersburg is an outstanding example of a successful collaboration between Russia and foreign investors in the high-technology and innovation sphere, creating new job opportunities for local talent,” said Valentina Matvienko, Governor of St. Petersburg. “We're looking forward to help Novartis in solving one of the key challenges on the government agenda - modernization of healthcare.”

This facility is part of a US$ 500 million five-year investment into Russian healthcare infrastructure announced by Novartis in December 2010. This comprehensive partnership addresses three core areas which are local manufacturing, R&D collaborations and public health development in Russia.

Novartis and its predecessors have been active in Russia since the 1860s, and today the company is one of the key players in the Russian pharmaceuticals market. Novartis currently employs over 2,000 professionals in Russia across all business divisions, spanning Pharmaceuticals, Alcon, Sandoz, Consumer Health and Vaccines & Diagnostics.

Novartis provides healthcare solutions that address the evolving needs of patients and societies and focused solely on healthcare, it also offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, consumer health products, preventive vaccines and diagnostic tools.

Novartis Aims to Recover Pace in China

Novartis AG expects growth in China to recover after business restructuring in the country slowed the Swiss drug giant's sales here last year, Chief Executive Joe Jimenez said.

The Basel-based pharmaceutical company plans this year to increase its sales force in China, with the aim of selling more drugs to local hospitals and health clinics, Mr. Jimenez said in an interview Monday. He declined to specify how many employees Novartis will add to the roughly 5,000 it has currently in China.

Novartis Pharmaceuticals Corporation restructuring US field force to align with changing product portfolio and strategic growth priorities

Novartis International AG / Novartis Pharmaceuticals Corporation restructuring US field force to align with changing product portfolio and strategic growth priorities Processed and transmitted by Thomson Reuters. The issuer is solely responsible for the content of this announcement.

- Elimination of 1,400 General Medicines field force positions effective January 1 to align organization with changes in portfolio and evolving healthcare market

- New organizational alignment creates leaner, more flexible and productive organization

East Hanover, N.J., November 30, 2010 - Novartis Pharmaceuticals Corporation (NPC) announced today that it is restructuring its General Medicines field force in the US to reflect changes in the product portfolio and align resources with strategic growth priorities. The company will reduce its General Medicines field force by approximately 1,400 positions. These changes will be effective January 1, 2011.

The product portfolio within the NPC General Medicines business is changing due to pending patent expirations and pipeline products. There are new product launches expected within the Primary Care business and significant growth momentum within the Specialty Care business that will drive long-term success. Given these changing dynamics within the portfolio, it is critical to realign the General Medicines field force to sharpen focus on the greatest opportunities for growth. The restructuring is expected to result in a one-time cost of approximately $85 million.

"NPC has a robust pipeline and the future growth potential for our organization remains strong. Proactively evolving our business model will enable us to focus our resources on key launch products and capture opportunities in both primary care and specialty medicines," said Andy Wyss, Head of Novartis Pharma North America and President of Novartis Pharmaceuticals Corporation.

All reductions will be handled in a manner consistent with the Novartis commitment to fair and respectful treatment of associates. Outplacement and other support services will be available to impacted associates as well as redeployment opportunities, where they exist, within the Novartis Group of companies.

Global drug majors bid for India's Paras

A clutch of global pharmaceutical majors have tendered bids for a majority stake in Indian drug-maker Paras Pharma , a report said Tuesday.

British giant GlaxoSmithKline , France's Sanofi-Aventis, Swiss multinational Novartis, and US-based Johnson and Johnson have all made bids for the over-the-counter drug major, reports said, citing sources close to the bidding process.

The initial bids ranged between the 600 and 700 million-dollar mark, one source told the newspaper, undershooting the expected valuation of close to one billion dollars.

"Serious players such as Japan's Taisho Pharmaceuticals are expected to join the race," one of the sources added.

Paras owns popular brands in the Indian market like anti-cold medication D'Cold and pain-relieving ointment Moov.

A Novartis spokesman contacted by AFP refused to comment on the report.

Utah to receive share of Novartis settlement

Utah will receive $150,000 from a $422.5 million settlement being paid to federal and state healthcare programs nationwide by a pharmaceutical company, Attorney General Mark Shurtleff said Monday.

Novartis Pharmaceutical Corp. settled over allegations of improper promotion of Trileptal, an anti-epileptic drug, for uses not approved by the Federal Drug Administration.

The settlement also resolves an investigation into alleged kickbacks to health care professionals for promoting and prescribing other drugs.

"Policing the pharmaceutical industry requires constant vigilance and a coordinated effort," Shurtleff said. "Holding companies accountable sends a message that we will not tolerate drug companies that violate the law."

The settlement requires the company to enter into an agreement that will be monitored by the U.S. Department of Health and Human Services inspector general's office.

Sun Pharma Announces USFDA Tentative Approval for Generic Stalevo®

Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Orion’s Stalevo® tablets.

These generic Carbidopa, Levodopa and Entacapone tablets contain Carbidopa, Levodopa and Entacapone 25/100/200 mg, and 37.5/150/200 mg.

Generic Carbidopa, Levodopa and Entacapone tablets are indicated in the treatment of Parkinson’s disease.

These strengths of Stalevo® have annual sales of approximately $ 95 million in the US.

®Manufactured by Orion Corporation.
Marketed by Novartis

R.I. gains share of drug settlement

The state is receiving $578,295 from a settlement with Novartis Pharmaceuticals Corp. to settle allegations that it engaged in an off-label marketing campaign that improperly promoted one of its drugs, Trileptal, and “engaged in unlawful kickback schemes” to induce doctors to prescribe that drug as well as five others, Attorney General Patrick C. Lynch announced Friday.

Lynch said in a news release that his office will forward $244,391 of that money to the state Department of Human Services, which administers Medicaid, the joint federal-state health insurance program for low-income Americans and certain people with disabilities. The balance of the settlement allocated to Rhode Island represents the federal portion of the Medicaid recovery and will go to the U.S. Department of Human Services.

“This is yet another in a long line of settlements with pharmaceutical companies that are boosting their profits at the expense of a program designed to assist the most vulnerable and needy Americans,” said Lynch. “While the circumstances vary, sheer greed is a common denominator in the exploitation of Medicaid by pharmaceutical manufacturers.”

Novartis Pharmaceuticals, a U.S. subsidiary of Novartis AG, the Swiss drugmaker, announced on Sept. 30 that it had reached a $422.5-million settlement with the U.S. Attorney’s office for the Eastern District of Pennsylvania that was conducting both criminal and civil investigations of the company’s off-label promotion of Trileptal, an anti-epileptic drug approved by the FDA for the treatment of patients who suffer seizures. A government investigation found that Novartis was inducing psychiatrists and other health-care providers to prescribe Trileptal for unapproved uses such as the treatment of bipolar disorder and neuropathic pain and that it also made illegal payments to doctors so that they’d promote and prescribe Trileptal.

The U.S. Attorney’s office also alleged that the company had engaged in civil wrongdoing by providing illegal payments through mechanisms such as payments for speaker programs, advisory boards and gifts, including entertainment and travel and meals to physicians to induce them to promote and prescribe the drugs Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.

The news release put out by Novartis said it had agreed to plead guilty to a misdemeanor charge of misbranding, pay a $185-million fine in connection with promoting uses of Trileptal that were not approved in this country and to pay $237.5 million to resolve the civil allegations involving all six drugs.

Novartis Settles Drug-Marketing Charges For $422.5M

A U.S. subsidiary of Novartis AG (NVS, NOVN.VX) has agreed to pay $422.5 million to resolve criminal and civil charges that it illegally marketed the epilepsy drug Trileptal and paid kickbacks to doctors.

The Justice Department and the company announced the agreement Thursday in which Novartis Pharmaceuticals Corp. will plead guilty to a misdemeanor charge and pay $185 million in criminal penalties.

The company will pay another $237.5 million to resolve civil allegations that it promoted Trileptal for off-label uses not approved by the U.S. Food and Drug Administration. The Justice Department also alleged Novartis paid kickbacks to doctors to encourage them to prescribe Trileptal and five other drugs. Kickbacks were provided through mechanisms such as speaker programs; advisory boards; and entertainment, travel and meals, the department said.

Prosecutors alleged Novartis was disappointed in the early sales of Trileptal when it launched in 2000, so the company decided to promote the drug for unapproved uses such as the treatment of nerve pain and bipolar disease. The drug maker trained, managed and rewarded its sales staff for those off-label promotional efforts, which continued until at least June 2004, prosecutors alleged.

They alleged Novartis profited by hundreds of millions of dollars through the misbranding and off-label promotion of Trileptal.

The Justice Department also alleged the drug maker's unlawful marketing activities caused false claims to be made to government health-care programs.

Thursday's civil settlement resolves four whistle-blower lawsuits filed by former Novartis employees. Under the federal False Claims Act, private litigants can obtain financial rewards by reporting that false claims have been made to the government.

The former employees will receive a total of more than $25 million.

As part of the Thursday's agreement, Novartis Pharmaceuticals will enter into a corporate integrity agreement that imposes several requirements. Among them, the company must post on its website information about payments it makes to doctors.

"Pharmaceutical companies have a legal obligation to promote the drugs they manufacture only for uses that the Food and Drug Administration has deemed are safe and effective," U.S. Attorney Zane David Memeger said in a statement. "That legal obligation takes priority over a company's bottom line."

Novartis said in a statement that it had previously disclosed the Justice Department investigation and announced earlier this year that it had set aside monetary provisions to cover the settlement. The company said it was pleased to resolve the matter.

"NPC will continue its commitment to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products," Andy Wyss, head of Novartis Pharma North America and president of Novartis Pharmaceuticals Corp., said in a statement.

While the Novartis unit pleaded guilty in the criminal case, it denied the kickbacks allegations made by the government in the civil case, according to court documents. The civil settlement indicates the parties resolved the case to avoid the uncertainty and expense of litigation.

Patent protection for Trileptal has expired in most countries, so sales have been damped by generic competition. In 2007, the year generic versions were launched in the U.S. and certain European countries, Trileptal sales were $692 million. It is no longer one of Novartis's top selling drugs.

Novartis Gets Rights To Broad-Spectrum Antibiotic

Swiss pharmaceutical company Novartis AG (NVS) said Thursday it has gained exclusive worldwide rights to market what could become the first once-a-day broad-spectrum antibiotic that can be given as a tablet or intravenously to treat infections caused by drug-resistant bacteria.

The drug candidate, dubbed PTK 0796, is currently in late-stage trials to treat patients with complicated skin and skin structure infections and Novartis will share the responsibility for developing the drug with U.S.-based privately held Paratek Pharmaceuticals.

"Its broad spectrum of activity means it could be used as a single agent against a range of bacteria, unlike other antibiotics which may have to be used in combination," the company said.

Gaining the rights makes a lot of strategic sense, said pharmaceuticals analyst Michael Nawrath of Zuercher Kantonalbank, who expects the share price to react positively. "The advantage over other such antibiotics already on the market is that it can be given in one dose, while for example Pfizer Inc.'s (PFE) Zyvox needs to be given in two doses a day," he said.

Based on an estimated 150,000 deaths a year from hospital-acquired infections across the U.S. and Europe, Nawrath sees peak sales potential of more than $1 billion.

Novartis highlighted that because PTK 0796 can be given as a 30-minute intravenous infusion or as a tablet and patients won't have to remain in hospital to receive the treatment. This would not only save healthcare costs, but also lower the risk of further infections.

Broad-spectrum antibiotics fight bacteria such as methicillin-resistant Staphylococcus aureus, or MRSA, which cause complicated, sometimes fatal skin infections and which are resistant to drugs already on the market.

Year-to-date, Novartis shares have lost 2.9%, underperforming a 4.6% rise in the European Health Care sector Stoxx 600. They closed at 51.20 Swiss francs ($49.80) Wednesday.

The in-licensing of PTK 0796 represents a further expansion of the Basel-based company's infectious diseases portfolio following the acquisition of Protez Pharmaceuticals in 2008.

Noven Pharmaceutical sale finalized

Hisamitsu Pharmaceutical Co. completed its $428 million purchase of Miami-based Noven Pharmaceutical, the companies said Friday.

Hisamitsu agreed to buy Noven on July 14 for $16.50 per share, which was a 22.4 percent premium to the most recent closing price for Noven stock.

Noven is now a wholly owned subsidiary of Hisamitsu U.S. It will keep its name, work force and current locations and remain a stand-alone unit. Noven shares will no longer trade on the Nasdaq Stock Market after Friday.

Noven's products include Vivelle-Dot estrogen patch, which is sold through a partnership with Novartis AG, and Daytrana, an attention deficit hyperactivity disorder patch licensed to Shire PLC.

Watson sees windfall as Toprol XL generic wins OK

Watson Pharmaceuticals Inc said on Monday U.S. regulators have approved its generic form of popular blood pressure drug Toprol XL, opening it to a lucrative market after shipments of two rival generics were suspended due to manufacturing problems.

London-based AstraZeneca Plc (AZN.L) reaps more than $700 million in annual U.S. revenue from Toprol XL and an authorized generic marketed by Par Pharmaceutical Companies Inc (PRX.N) that uses the same active ingredient.

Two other generics had been sold in the United States by Swiss drugmaker Novartis AG (NOVN.VX) and by KV Pharmaceutical Co (KVa.N) (KVb.N), but the companies suspended shipments of those copycats more than six months ago due to manufacturing issues cited by the U.S. Food and Drug Administration.

Novartis, which introduced its generic in 2007, stopped shipments in December 2008. KV Pharmaceutical suspended shipments of its four dosage forms in January.

"We get these opportunities every once in a while and this is one of those unique opportunities," said Watson spokeswoman Patty Eisenhaur, referring to the sudden recent disappearance from the U.S. market of the rival Novartis and KV Pharmaceutical generics.

Eisenhaur said her company's approved 25- and 50-mg dosage forms are the two most widely prescribed strengths of Toprol XL, and will be shipped immediately. She noted that Watson is hopeful of winning U.S. approval later this year for the 100-mg and 200-mg strengths.

"To become one of the full suppliers of a drug of this magnitude is a terrific opportunity," Eisenhaur said.

Watson last week predicted its generic would be approved in "the near term."

AstraZeneca raised its full-year profit forecast on July 30 after better-than-expected second-quarter results, helped by its lucky break of escaping generic competition earlier in the year on the Novartis and KV Pharmaceutical generics.

KV Pharmaceutical is unlikely to pose a threat anytime soon to Watson's newly approved product.

The cash-strapped company last week said it does not expect to re-initiate shipments of its medicines prior to the third quarter of fiscal 2010, at the earliest.

The suburban St. Louis drugmaker expressed doubts about its ability to continue as a going concern, given that it has refrained from manufacturing and shipping any of its medicines due to a consent decree it entered with the FDA.

The FDA in August 2008 cited Novartis for failing to properly validate the manufacturing process for making Toprol XL tablets at a plant in North Carolina.

Drug Approved for Hypercalcemia of Malignancy

Novartis has received marketing approval from the U.S. Food and Drug Administration for Zometa (zoledronic acid for injection) for the treatment of hypercalcemia of malignancy (HCM), the most common life-threatening metabolic complication associated with cancer.

Two clinical trials involving 275 patients showed significant differences between treatment with Zometa and the current standard treatment with respect to the percentage of complete responders, according to a company release.

Novartis Raises Forecast as New Treatments Buoy Sales

Novartis AG raised its drug sales forecast, saying new medicines to battle blindness, hypertension and brittle bones may buoy revenue this year.

Europe’s second-largest drugmaker estimated pharmaceutical sales would rise at a “high-single-digit rate,” compared with an earlier forecast of a “mid-to-high-single-digit rate.” The Basel, Switzerland-based company, which reported a 10 percent profit drop today, didn’t give a more precise estimate.

Novartis said seven new treatments introduced since the start of 2008, including Exforge to lower blood pressure and Reclast for osteoporosis, saw sales rise 91 percent in local currencies in the first six months of the year.

“Raising the guidance was today’s positive surprise,” Karl Heinz Koch, an analyst at Helvea SA in Zurich, said in a telephone interview. “The new products are holding their own quite well.”

Novartis rose as much as 88 centimes, or 2 percent, to 44.58 Swiss francs in Zurich trading. The drugmaker’s shares have fallen 18 percent this year, making it the worst-performing stock on the Bloomberg Europe Pharmaceutical Index.

Novartis also said today it’s making progress on a vaccine against pandemic flu. Clinical tests for an injection against the H1N1 virus will start this month and the U.S. government has ordered $979 million worth of the product and of an adjuvant known as MF59, designed to boost the patient’s immune response and make the shot more effective.

Dollar Hurts

Chief Executive Officer Daniel Vasella is “doing a good job. Not an excellent job, but a good job,” said Dieter Buchholz, who manages $12 billion in Swiss and U.S. assets as head of equities for Falcon Private Bank.

The dollar’s strength against the euro caused earnings and sales to slide last quarter.

Net income dropped to $2.04 billion from $2.25 billion a year earlier, the drugmaker said today. Older products like the Diovan hypertension pill and Gleevec for cancer helped fuel an 8 percent sales gain that was wiped out when Novartis converted the revenue into dollars. Sales fell 2 percent to $10.5 billion.

The results were in line with analysts’ estimates. Earnings may improve in the second half should the dollar weaken, according to Fabian Wenner, an analyst at UBS AG in Zurich.

From the end of the second quarter of 2008 through June 30 of this year, the dollar gained 12 percent against the euro, reducing the value of Novartis’s sales in Europe.

Menveo Delay

Profit may drop this year if exchange rates remain where they are, Novartis said. Sales from continuing operations will probably rise at a mid-single-digit percentage rate this year in local currencies. Drug sales will likely grow at a high-single- digit rate in local currencies, Novartis said.

Novartis suffered a setback in July when the U.S. Food and Drug Administration asked for more information on the experimental meningitis vaccine Menveo, delaying the shot’s approval. Menveo is one of the products Novartis expects to drive revenue after the company loses patent protection on its two biggest-selling products, Diovan and Gleevec.

Sales at the drug unit rose 3 percent to $7.1 billion last quarter, driven by Gleevec and Diovan. Revenue from vaccines dropped 23 percent because of a comparison with the year-earlier period, when demand for an experimental shot against bird flu lifted sales. Sales at the generic drug unit Sandoz declined 9 percent to $1.8 billion, while consumer health lost 8 percent to $1.4 billion

Pandemic flu shows need for pharma incentives -WHO

* Health threats such as H1N1 require new drugs, jabs -WHO

* Ideal H1N1 vaccine would include seasonal, other viruses

GENEVA, - Pharmaceutical firms need incentives, including lucrative patents, to keep creating drugs and vaccines against emergent threats such as the H1N1 influenza pandemic, the World Health Organisation's head said on Tuesday.

"Progress in public health depends on innovation. Some of the greatest strides forward for health have followed the development and introduction of new medicines and vaccines," said WHO Director-General Margaret Chan said.

Chan, who last month declared a full pandemic underway from the H1N1 virus, said that patents can help ensure that companies develop medicines to "stay ahead of the development of drug resistance" in diseases like malaria and tuberculosis.

The discovery of isolated H1N1 infections that resist the anti-viral Tamiflu, made by Roche (ROG.VX) and Gilead (GILD.O), and the global scramble to secure flu vaccines have shown the importance of robust research and development, Chan said.

"Innovation is needed to keep pace with the emergence of new diseases, including pandemic influenza caused by the new H1N1 virus," she told a meeting on intellectual property and health, a contentious issue that has divided rich and poor nations.

In the speech, Chan said most drug access problems faced by developing countries could be remedied by tinkering with the existing patent system, which "operates as a stimulus for research and development for new products."

In May, at the WHO's annual assembly, rich and poor nations failed to reach consensus on how they should share virus samples of H1N1 and other flu strains with companies that use the biological material to make vaccines.

Indonesia has been especially vocal against this, arguing that developing countries would not be able to afford patented jabs made from their specimens.

PROBLEMS WITH PATENTS

Chan said those talks on "one of the most difficult, and divisive, issues ever negotiated by WHO" had identified problems with patents but said that the existing intellectual property regime did not need to be fully dismantled in pursuit of equity.

"R&D can indeed be needs-driven as well as profit driven," the former Hong Kong health director said. "International agreements that govern the global trading system can indeed be shaped in ways that favour health needs of the poor."

Chan described the global vaccine making capacity as "finite and woefully inadequate for a world of 6.8 billion people, nearly all of whom are susceptible to infection by this entirely new and highly contagious virus."

While acknowledging that "the lion's share of these limited vaccines will go to wealthy countries," she said the shortfall was "the result of limited global manufacturing capacity. It is not, in essence, a result of intellectual property issues."

The WHO has recommended that health workers, pregnant women and children should get priority access to H1N1 vaccines, and noted that every country worldwide will need them. [ID:nLD54719]

Chan said the ideal H1N1 shot would protect against seasonal strains as well as a range of candidate pandemic viruses.

"This innovation has not come about yet," she said. "This would be the best and most rational insurance policy for increasing supplies and encouraging more equitable access."

Top flu vaccine makers include Sanofi-Aventis (SASY.PA), Novartis (NOVN.VX), Baxter (BAX.N), Schering Plough's (SGP.N) Nobilon, GlaxoSmithKline (GSK.L), Solvay (SOLB.BR) and AstraZeneca's (AZN.L) MedImmune.

Two Major Pharmaceutical Makers Will Donate Swine Flu Vaccines

Pharmaceutical companies around the world are hard at work to develop a vaccine that minimizes or eliminates a person’s chance of getting the H1N1 swine flu now sweeping the globe in pandemic proportion. For some of these drug companies, the expected bottom line is driving the research frenzy but two major players have agreed to donate substantial quantities of their vaccines to the World Health Organization (WHO) for use in the world’s poorest companies. According to the chief executive officer of one of them, “We all have to play our part.”

Chris Viehbacher, CEO for Sanofi-Aventis SA, based in Paris, France, says his company will donate 100 million doses of the flu vaccine as soon as the vaccine reaches the production phase. According to Viehbacher, Sanofi has allocated a 10% output reserve for the WHO. He further states playing its part means more than just getting the vaccines only to countries wealthy enough to pay for them, especially in the midst of pandemic illness.

GlaxoSmithKline PC (GSK) will also donate some of the vaccine it’s developing to the WHO, according to company spokesperson, Stephen Rea. Rea says GSK plans to donate 50 million doses.

These announcements of donated vaccine come on the heels of an announcement made by the Swiss pharmaceutical company, Novartis AG, in which the company said it would not be donating any vaccine. Company spokesperson Eric Althoff said donated vaccines won’t effectively address need during time of pandemic but the company is exploring pricing strategies and other measures to allow ample access.

In response to the Novartis announcement, Sanofi’s Viehbacher agreed that donations aren’t sustainable and can’t be relied upon in the long term but he acknowledged the exceptional situations created during pandemic. Saying pandemics are not on-going events and the company is determined to do what it can to help, Viehbacher said the company’s proposed donations to the WHO will not affect its profit margin. Sanofi is considering a policy of tiered pricing in developing countries where its drug manufacturing facilities are completely committed to H1N1 vaccine production.

In a press briefing last week, WHO director-general, Margaret Chan, called on the world’s wealthiest nations to help ensure the vaccine is accessible in even the poorest nations. The agency declared pandemic on June 11 and urged pharmaceutical companies to begin vaccine production.

There are 35,928 confirmed cases of the H1N1 swine flu in the world today, according to WHO data. Swine flu is now in 76 countries and 163 deaths have been officially attributed to it. Health officials are keeping close watch on the virus as it spreads during the Southern Hemisphere winter season. Flu viruses are usually most active during the coolest months of the year and public health officials are concerned the virus may mutate into a more virulent strain that causes more severe symptoms than the current strain causes.

Drug Companies Pressed to Reduce Vaccine Prices

Pharmaceutical companies, governments and civic groups should cooperate to provide more vaccines against various viruses, Dr. John Clemens, director general of the International Vaccine Institute (IVI) in Seoul, said.

Civic groups worldwide have called on companies such as Baxter and Novartis _ developers of a vaccine for H1N1 influenza A _ to reduce their prices so that more people can be treated.

Some are asking them to release the formula for the drugs before patents expire, for humanitarian purposes.

However, Clemens says this might not be the best idea. ``It takes five or more years and $500 million or more to develop some drugs and forcing companies to give up profits may discourage them from pursuing the next challenge.''

He said these days global organizations and drug makers often let people in relatively wealthy nations buy the drug first at higher prices to allow the companies to satisfy their shareholders, and then provide it to poorer countries at lower prices. Also, large charity groups such as the Bill & Melinda Gates Foundation and others have joined hands with drug companies to reduce prices. ``Fortunately, more and more companies are understanding the need for such policies these days,'' he said.

The awareness, or fear, of a ``virus'' is higher than ever. Some people dread that it will be the virus that puts an end to human life, as seen in novels such as ``I Am Legend'' or movie ``Night of the Living Dead.'' The Ebola virus, SARS, avian influenza and others have become major threats to mankind in less than a decade.

The latest H1N1 influenza A has fueled this fear. The World Health Organization said 44,287 people have been infected with the virus and 180 have died, after recently posting a ``phase 6'' pandemic alert. The Korean government announced that 105 people have been infected here.

On the question of why the prevalence of the virus infection is quite different according to countries or continents _ 44 and 113 died in the United States and Mexico, respectively but none here _ he said it takes time and research to find out. ``A virus is alive and it can evolve in a short period of time. We will have to see whether the virus has changed into a different form on its way to other countries or whether it is more powerful against specific ethnicities,'' he said.

The IVI is a United Nations organization that has its headquarters in Seoul.

The institute was established to provide vaccines to third world countries and is conducting research in 22 countries in Asia, Africa and Latin America, seeking ways to dispense vaccines at affordable prices. Originally part part of the United Nations Development Program, it was separated off in 1997.

It began vaccinating children in North Korea against Japanese encephalitis and meningitis last year _ 55 out of every 1,000 children in North Korea die before celebrating their fifth birthday, something the United Nations Children's Fund call alarmingly high.

The institute is located on the Seoul National University campus, and the Korean government finances about 30 percent of its operational costs.

China's Sinovac enters race for flu vaccine

*Sinovac hopes to have vaccine trial by end-July

*Company using traditional chicken-egg virus production methods

BEIJING, - Chinese vaccine maker Sinovac Biotech Ltd (SVA.A) hopes to put its H1N1 vaccine through its first clinical trial by the end of July, as pharmaceutical firms race to put vaccines against the new flu virus into commercial production.

Workers at Sinovac's laboratory in Beijing readied thousands of chicken eggs to grow the H1N1 virus on Monday, after the World Health Organization declared a pandemic last Thursday and warned governments to prepare for a long battle against the virus. [ID:nNLB765857]

On Friday, Novartis AG (NOVN.VX) said it expected its H1N1 vaccine to be available by autumn after it produced a first batch for testing and clinical trials [ID:nLB532879]. Baxter International Inc (BAX.N) said it was on full-scale production and hoped to have a commercially available A/H1N1 vaccine as early as next month.

China has recorded about 200 cases of H1N1, and is eager to prevent it from spreading among the wider population. Experts worry that if the disease becomes prevalent in China, with its huge population and uneven health services, it could mutate into something easily transmissible and far more deadly.

"The most difficult part is that we are not sure about the performance of the virus seed since it is completely new to us," Sinovac's regulatory director, Gong Xuejie, told Reuters at the company's plant in northwestern Beijing.

"Time is very short. We don't know whether we will be able to produce enough vaccines before the second wave of mass breakout."

Sinovac plans to apply the techniques it used in designing candidate vaccines against the more lethal H5N1 bird flu virus to produce its H1N1 vaccine.

Vaccines normally take much longer to develop and test. Novartis and Baxter have chosen cell-based culture methods, which they say is faster than traditional production methods that use chicken eggs.

Sinovac will use an inactivated virus as well as an adjuvant in its vaccine. Adjuvants are additives that increase the body's immune response while reducing the amount of antigen, or active ingredient, in each shot, its spokesman, Pearson Liu, said.

"We can produce the vaccines in such a short time thanks to our research and development of human vaccines against the H5N1 influenza strain," Gong said.

"We set up the platform for developing and producing H5N1 vaccines last year, and we also got approval from the State Food and Drug Administration. We just switched the virus seed this year based on the technologies and the platform we had set up."

The company, in cooperation with other Chinese pharmaceutical firms, is mass producing ingredients needed for the vaccine. Once it works out the right dosage to use and ensures safety, it will be able to kickstart mass production, officials said.

Sinovac's announcement that it would produce the vaccine lifted the company's shares (SVA.A) by 14 percent last week. They touched their highest point in a year and a half after the WHO declared the H1N1 pandemic.

Rival Chinese and Western pharmaceutical firms also saw their shares rise due to the WHO announcement

Vaccine makers boost U.S. pharma stocks

BOSTON - Vaccine makers helped boost the U.S. pharmaceutical benchmark index early Friday as shares of GlaxoSmithKline PLC (GSK 36.75, +0.19, +0.52%) , AstraZeneca PLC (AZN 43.34, +0.05, +0.12%) , Novartis AG (NVS 42.00, +0.05, +0.12%) and Sanofi-Aventis (SNY 33.37, +0.14, +0.43%) all gained in the wake of Thursday's declaration of a formal flu pandemic by the World Health Organization. The Amex Pharmaceutical Index (DRG 260.48, +3.17, +1.23%) rose 1% to 259.95 while the Amex Biotechnology Index (BTK 683.44, -5.46, -0.79%) slid 1.5% to 678.74. The Dow Jones Industrial Average back-tracked about 25 points to 8,747.