22 Hot Drugs Facing FDA Approval in 2012

Updated with three additional drug approval decision dates.

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

The calendar on the following pages captures nearly two-dozen U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between December 2011 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.

Affymax ( AFFY)
Drug/indication:peginesatide for anemia in kidney dialysis patients.
FDA advisory panel: Dec. 7, 2011
Approval decision date:March 27, 2012
Peginesatide, injected once monthly, aims to compete against Amgen's ( AMGN) Epogen ($2.5 billion in 2010 sales) as a treatment for anemia in patients with chronic kidney disease, although peginesatide use would be limited to sicker kidney dialysis patients only. Amgen recently signed long-term Epogen supply contracts with the two largest kidney dialysis clinics in the U.S.

Pfizer ( PFE)
Drug/indication:Inlyta (axitinib) for kidney cancer
FDA advisory panel: Dec. 7, 2011
Approval decision date: Feb-April 2012

Alexza Pharmaceuticals ( ALXA)
Drug/indication:Adasuve for agitation related to schizophrenia
FDA advisory panel: Dec. 12, 2011
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.

Vivus ( VVUS), Arena Pharmaceuticals ( ARNA) and Orexigen Therapeutics ( OREX)
Drugs/indication: Qnexa, lorcaserin and Contrave for obesity.
FDA advisory panel: First quarter 2012 (exact date not yet disclosed.)
FDA held advisory panels to review all three of these controversial weight-loss drugs in 2010. FDA subsequently rejected all three drugs. In 2012, Vivus and its obesity drug competitors are back for another shot, and FDA will once again bring together a group of outside experts to weigh the pros and cons of treating obesity with a pill.

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 Labs ( CBRX) and Watson Pharmaceuticals ( WPI)
Drug/indication:progesterone vaginal gel for risk reduction of preterm 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) and Protalix Biotherapeutics ( PLX)
Drug/indication: Uplyso for Gaucher's disease.
Approval decision date: Feb. 1, 2012
FDA has twice-rejected Uplyso due to manufacturing and quality control issues. If approved this time around, Uplyso will compete against Sanofi/Genzyme's ( SNY) Cerezyme and Shire's Vpriv.

Teva ( TEVA) and BioSante Pharmaceuticals ( BPAX)
Drug/indication: Bio-T-Gel for hypogonadism
Approval decision date: Feb. 14, 2012
Bio-T-Gel is a once-daily gel used to treat low testosterone in men.

Corcept Pharmaceuticals ( CORT)
Drug/indication: Corlux for Cushing's Syndrome.
Approval decision date: Feb. 17, 2012
FDA will not convene an advisory panel to review Corlux.

Discovery Labs ( DSCO)
Drug/indication: Surfaxin for respiratory distress syndrome in premature infants.
Approval decision date: March 6, 2012
This is Discovery's fifth attempt at convincing FDA to approve Surfaxin.

Roche ( RHHBY) and Curis ( CRIS)
Drug/indication: Vismodegib for advanced basal cell carcinoma.
Approval decision date: March 8, 2012.

MAP Pharmaceuticals ( MAPP)
Drug/indication: Levadex for migraines
Approval decision date: March 26, 2012
Levadex is an inhaled migraine drug. FDA has not yet announced whether it intends to hold an advisory panel to review Levadex.

Chelsea Therapeutics ( CHTP)
Drug/indication: Northera for orthostatic hypotension
Approval decision date: March 28, 2012

Pfizer ( PFE) and Bristol-Myers Squibb ( BMY)
Drug/indication: Eliquis for prevention of stroke and blood clots in patients with atrial fibrilation.
Approval decision date: March 28, 2012

Onyx Pharmaceuticals ( ONXX)
Drug/indication: Carfilzomib for multiple myeloma
Approval decision date: March 28, 2012 (estimated, not confirmed, based on Sept. 28, 2011 filing date.
FDA accepted the carfilzomib filing on Nov. 28 but has not yet set a specific approval decision date. I'm assuming a six-month priority review because carfilzomib is a cancer drug.

Vivus ( VVUS)
Drug/indication: Qnexa for obesity
Approval decision date: April 17, 2012
FDA rejected Qnexa initially in 2010 due to safety concerns.

Vertex Pharmaceuticals ( VRTX)
Drug/indication: Kalydeco for cystic fibrosis
Approval decision date: April 19, 2012
Kalydeco is the first drug to treat the underlying cause of cystic fibrosis in patients with a specific genetic defect.

Cell Therapeutics ( CTIC)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
Approval decision date: April 2012 (Specific date unknown.)
Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone, setting up the drug's second chance at U.S. approval.

Amgen ( AMGN)
Drug/indication: Xgeva for prevention of bone metastases from prostate cancer.
Approval decision date: April 26, 2012

VVUS ( VVUS)
Drug/indication: Avanafil for erectile dysfunction.
Approval decision date: April 29, 2012

Merck ( MRK) and Ariad Pharmaceuticals ( ARIA)
Drug/indication: ridaforolimus for sarcoma.
Approval decision date: June 5, 2012

Ironwood Pharmaceuticals ( IRWD)
Drug/indication: linaclotide for irritable bowel syndrome.
Approval decision date: June 8, 2012

Amarin ( AMRN)
Drug/indication: AMR101 for dyslipidemia.
Approval decision date: July 26, 2012

Sources: Company reports, TheStreet research, BioMedTracker.com

--Written by Adam Feuerstein in Boston.

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