27 Hot Drugs Facing FDA Approval in 2012

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.

NeurogesX ( NGSX)
Drug/indication: Qutenza for HIV-associated peripheral neuropathy
FDA advisory panel: Feb. 9, 2012
Approval decision date: March 7, 2012

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.

Chelsea Therapeutics ( CHTP)
Drug/indication: Northera for orthostatic hypotension
FDA advisory panel: Feb. 23, 2012 (tentative) Approval decision date: March 28, 2012

Vivus ( VVUS), Arena Pharmaceuticals ( ARNA) and Orexigen Therapeutics ( VVUS)
Drugs/indication: Qnexa, lorcaserin and Contrave for obesity.
FDA advisory panel: The Endocrinologic and Metabolic Drugs Advisory Committee has tentative meetings scheduled for Feb. 22 and March 28-29, 2012.
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.

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.

Affymax ( AFFY)
Drug/indication:peginesatide for anemia in kidney dialysis patients.
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. On Dec. 7, an FDA advisory panel voted 15-1 to recommend peginesatide's approval.

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 18, 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 24, 2012
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

Pfizer ( PFE) and Protalix Biotherapeutics ( PLX)
Drug/indication: Uplyso for Gaucher's disease.
Approval decision date: May 1, 2012
FDA has twice-rejected Uplyso due to manufacturing and quality control issues and delayed a third decision from February to May. If approved this time around, Uplyso will compete against Sanofi/Genzyme's ( SNY) Cerezyme and Shire's Vpriv.

Talon Therapeutics ( TLON)
Drug/indication: Marquibo for acute lymphoblastic leukemia (ALL)
Approval decision date: May 13, 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

Navidea Biopharmaceuticals ( NAVB) Formerly Neoprobe
Drug/indication: Lymphoseek, a lymph node tracing agent.
Approval decision date: June 10, 2012

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

Horizant Pharmaceuticals ( HZNT)
Drug/indication: Lodotra for rheumatoid arthritis
Approval decision date: July 26, 2012

Onyx Pharmaceuticals ( ONXX)
Drug/indication: carfilzomib for multiple myeloma
Approval decision date: July 27, 2012

Sources: Company reports, TheStreet research, BioMedTracker.com

--Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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