FDA Warns About Glaxo's Asthma Drug; Novavax Boosted By Vaccine Study

Here's a roundup of some of the major news moving stocks in the pharmaceutical industry today:GlaxoSmithKline (GSK) shares are down about 1.5% after the U.S. Food and Drug Administration warned against long-term use of its asthma treatments, Advair and Serevent. Advair is the British pharmaceutical firm's best-selling product, but could now suffer a serious blow following regulators' call for further study of potential health risks. Advair had total sales of 1.366 billion euros ($1.859 billion) in the fourth quarter of 2009, of which more than half -- 704 million euros ($958 million) -- came out of the U.S.

The new label warning isn't limited to Glaxo's meds; Novartis's (NVS) Foradil and AstraZeneca's (AZN) Symbicort are affected as well. The four widely used asthma treatments belong to a class of drugs known as long-acting beta agonists (LABAs), which open airways. Other steroid-based meds control inflammation. The new label warns that LABAs "should never be used alone in the treatment of asthma in children or adults," and should be used only for the "shortest duration of time required to achieve control of asthma symptoms," then discontinued. These medicines can actually worsen asthma symptoms, the FDA said, "leading to hospitalization in both children and adults and death in some patients with asthma."

Dr. Katharine Knobil, vice president for respiratory clinical research at GlaxoSmithKline said the company "will work with FDA to ensure that the final label for these products protects the interest of patients who suffer with this chronic and serious disease."

Novavax (NVAX) shares, meanwhile, jumped over 5% on Friday, after the company presented positive study results for its swine flu vaccine at the World Health Organization conference in Geneva. Data from the 1,000-person study shows the vaccine was well tolerated at all three dose levels and achieved robust serological immune responses that are considered protective.

Novavax's vaccine came to the spotlight this year during the H1N1 scare as vaccine shortages were common across the globe. Traditional vaccines are grown in chicken eggs and take months to produce. Novavax claimed its virus-like particles technology cuts down the time it takes to manufacture a vaccine to weeks. While the swine flu scare has subsided for now, a quicker vaccine production method would be welcome in case of another scare.

United Therapeutics (UTHR) said it had withdrawn the European marketing application for its hypertension treatment drug, Tyvaso. The data in the application is based upon clinical work performed from 2005 to 2007 by United Therapeutics' subsidiary Lung Rx, the company said. But European regulators found that two clinical sites were not in compliance with good clinical practices, so the company will have to redo the study. The drug has already been approved in the U.S. The company said its "revenue growth targets were unaffected by the move," but shares still fell some 2% on Friday.

In Brief:
  • Novartis (NVS) said Friday that its Tasigna drug has been granted priority review by the FDA for the treatment of newly diagnosed patients with early-stage chronic myeloid leukemia.
  • GenVec Inc. (GNVC) announced a new contract with the Department of Homeland Security to continue the development of vaccines against foot-and-mouth disease under a new contract worth as much as $4.5 million. Shares jumped over 6%.
  • Shire (SHPGY) shares climbed over 4.5% as the U.K. drugmaker beat fourth-quarter profit estimates and forecast a return to revenue and earnings growth in 2010.
  • Roche's (RHHBY) Genentech acquisition continues to bear fruit with the FDA approval of Rituxan, its monoclonal antibody cancer drug, for the treatment of certain patients with chronic lymphocytic leukemia. CLL is a slowly progressing blood and bone marrow cancer affecting 16,000 patients every year.
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