Biotech Calendar: Key Dates for March

March 21

FDA approval decision date for Somaxon Pharmaceuticals'(SOMX) Silenor for insomnia.

March 24

FDA approval decision date for Salix Pharmaceuticals'(SLXP) Xifaxan for hepatic encephalopathy.
Centers for Medicare and Medicaid Services (CMS) advisory committee meeting to discuss erythropoietin-stimulating agents for treatment of chronic kidney disease. Amgen(AMGN) and Johnson & Johnson(JNJ).

March 29

FDA approval decision date for Cephalon's(CEPH) Nuvigil for treatment of jet lag disorder

Ongoing FDA drug reviews with no approval decision date:

Mannkind's(MNKD) Afrezza (inhaled insulin) for diabetes

Companies with important, pending clinical trials:

Company: Allos Therapeutics(ALTH)
Drug: Folotyn in non-small cell lung cancer.
Allos is conducting this phase II study to demonstrate the feasibility of using Folotyn to treat certain patients with non-small cell lung cancer. Folotyn was recently launched commercially as a treatment for peripheral T-cell lymphoma, a relatively small blood cancer indication. The study in non-small cell lung cancer is important because it could potentially expand Folotyn's devlopment to larger, solid tumor cancer indications.

Company: GenVec(GNVC)
Drug: TNFerade for pancreatic cancer.
GenVec is conducting a second interim analysis of a pivotal phase III study comparing the effect on overall survival of TNFerade plus the standard of care versus standard of care alone in patients with pancreatic cancer.

Company: Medivation(MDVN)
Drug: Dimebon for Alzheimer's disease.
The phase III study of Dimebon in patients with mild to moderate Alzheimer's disease is shaping up to be one of the biggest binary events in biotech this year. Current Alzheimer's drugs are only moderately effective, so Dimebon has the potential to be a billion dollar-plus blockbuster if it can duplicate the positive results from an earlier, phase II study. Pfizer(PFE) is Medivation's partner on Dimebon.

-- Reported by Adam Feuerstein in Boston.

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