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TheStreet Open House

27 Hot Drugs Facing FDA Approval in 2012

Stocks in this article: CORTCHTPDSCOCRISMAPPVVUSTLON

BOSTON ( TheStreet) -- Here's an updated look at the biotech and pharmaceutical companies with pending FDA drug approval decisions in 2012.

The calendar on the following pages (updated from when it was last published on Nov. 29) captures the most important U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between January and July 2012. As every savvy biotech investor and trader knows, the volatility in biotech and drug stocks ramps significantly as U.S. regulators weigh whether to approve or reject new drugs.

Among the highlights from the 2012 FDA drug-approval calendar that should be of most interest to bio-pharma investors: A first-quarter FDA advisory panel that will once again tackle the thorny issue of obesity-drug safety, including Vivus' (VVUS) Qnexa; approval decisions for novel inhaled medicines from Alexza Pharmaceuticals (ALXA) and MAP Pharmaceuticals (MAPP); and the fifth (!!) attempt at approval for Discovery Labs' (DSCO) lung therapy for premature infants.

Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst.

Biogen Idec (BIIB) and Elan (ELN)
Drug/indication:Update to the Tysabri prescribing label
Approval decision date: Jan. 20, 2012
The Tysabri label update will include information about the anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML). Doctors can use to test to determine which multiple sclerosis patients are at low or high risk for PML, a serious, potentially fatal brain infection caused by Tysabri.

Columbia Laboratories (CBRX)
Drug/indication: Prochieve for reduction of risk of premature birth.
FDA advisory panel: Jan 20, 2012
Approval decision date: Feb. 26, 2012

Amylin Pharmaceuticals (AMLN)
Drug/indication: Bydureon for diabetes
Approval decision date: Jan. 27, 2012
This is the second shot at approval for Bydureon, a once-weekly injectable medicine for the treatment of Type 2 diabetes. Amylin recently split with its long-time marketing partner Eli Lilly (LLY). Alkermes (ALKS) retains its royalty split on Bydureon sales.

Bristol-Myers Squibb (BMY)
Drug/indication: dapagliflozin for diabetes
Approval decision date: Jan. 27, 2012

Pfizer (PFE)
Drug/indication:Inlyta (axitinib) for kidney cancer
Approval decision date: Feb-April 2012
On Dec. 7, an FDA advisory panel voted 13-0 to recommend Inlyta's approval.

Alexza Pharmaceuticals (ALXA)
Drug/indication:Adasuve for agitation related to schizophrenia
Approval decision date: Feb. 4, 2012
Adasuve uses Alexza's proprietary Staccato inhaler system to deliver the anti-agitation medicine loxapine directly into the lungs where it gets into the bloodstream and begins to work quickly. The FDA advisory panel is expected to focus much of its attention on the potential side effects and safety issues related to delivering Adasuve into patients' lungs.

FDA initially rejected Adasuve in October 2010 due to concerns over lung safety. Alexza resubmitted the drug to FDA last August. On Dec. 12, an FDA advisory panel voted 9-8 with one abstention to recommend approval of a single dose of Adasuve. The panel also recommended the drug only be distriuted with a restrictive risk-management plan.

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