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Merck, Affymax, Chelsea Therapeutics Face Key Dates in March


Investors take note. The month features a slew of FDA actions and review panels.

Editor's Note: Updated 8:45 am on March 1.

Drug and biotech investors will be busy in March. There's a slew of approval decisions and government reviews of drugs scheduled for the month. A number of big and small companies await decisions on US approvals for new drugs or expanded uses of existing medicines.

Below is a list of highlights for the month. Dates are subject to change, particularly new drug decisions from the US Food and Drug Administration. The agency sometimes delays approval decisions or announces them before scheduled deadlines.

March 6
Astex Pharmaceuticals (ASTX) expects a decision from the FDA on the expanded use of Dacogen for a type of leukemia. Odds are the agency will reject the application after a negative vote from a panel of advisers in early February. (See Blood Disease Drug Dacogen Gets Thumbs Down for Cancer Use.) Astex partner Johnson & Johnson (JNJ) markets the drug overseas.

Discovery Laboratories (DSCO) should hear from the FDA on its latest application to sell Surfaxin, a treatment designed to prevent respiratory distress syndrome in premature babies. The small-cap company has been trying to win approval for Surfaxin since 2004. The FDA rejected the product for a fourth time in spring of 2009.

March 7
Neurogesx (NGSX) should get word from the FDA on its application to sell its Qutenza patch for nerve pain in HIV patients. The product is already approved to treat pain associated with shingles. FDA advisers voted unanimously against the expanded use in a meeting in early February.

March 20
Ariad Pharmaceuticals (ARIA) and partner Merck (MRK) face a panel of FDA advisers reviewing the cancer drug Taltorvic for metastatic soft-tissue or bone sarcoma. Ariad, whose stock has more than doubled over the past year, licensed the drug to Merck.

That same panel will review GlaxoSmithKline's (GSK) application to market the drug Votrient for advanced soft tissue sarcoma. Votrient already is approved to treat patients with advanced kidney cancer.

March 21
Bulletin Board stock Talon Therapeutics will go before an FDA advisory committee for its experimental treatment Marqibo for a type of leukemia.

March 26
Map Pharmaceuticals (MAPP) is expected to hear from the FDA on possible approval of its inhaled drug Levadex for migraine headaches. Levadex is Map's lead product candidate. Shares of the company have risen more than 20% this year.

March 27
(AFFY) should get a decision from the FDA on possible approval of peginesatide, an anemia treatment for people with kidney failure. If approved, Affymax would challenge Amgen's (AMGN) Epogen. Affymax's stock almost doubled since December after FDA advisers voted to approve the drug. (See Affymax's Stock Soars on Hope for Anemia Drug Approval.)

March 28
Chelsea Therapeutics (CHTP) should find out whether the FDA will approve a drug aimed at treating low blood pressure in people with Parkinson's disease and similar disorders. The agency's advisers voted in favor of the drug last week. However, FDA staff raised questions about the drug's safety and effectiveness prior to the advisers' meeting. (See Chelsea Therapeutics Shares Plunge on Drug Study Concerns.)

Bristol-Myers Squibb (BMY) and Pfizer (PFE) expect to hear from the FDA on an application to sell the blood-thinning drug Eliquis. The drug is potentially a big seller and an approval would be a boost to the big pharma companies. (See A Pair of Catalysts Boost Pfizer's Shares.)

Update: The FDA decision date on Eliquis has been extended by three months, Bristol-Myers and Pfizer said late Wednesday night. The new date is June 28.

"The companies submitted additional information about the Eliquis clinical program to the FDA, which constitutes a major amendment to the application and will require additional time for review," according to a statement by the companies.

Twitter: @brettchase

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