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10 Biotech Stocks Facing FDA Judgment Day

Drug approval decisions by the Food and Drug Administration can be important stock-moving events. But putting together a calendar of these potential catalysts can be difficult.

The FDA's Web site isn't very helpful, and unless you have access to scores of sell-side research reports, you're pretty much on your own. It's no wonder I get a lot of email from readers asking for biotech event calendars.

Here's some help. I've put together a list of key upcoming FDA drug approval decisions for the rest of the year. This isn't comprehensive, but it does cover most, if not all, new drugs being developed by biotech firms. There are a few specialty pharma and Big Pharma drugs on the list, too.

Here are some of the more notable pending FDA decisions:

Cephalon (CEPH)
Drug/indication: Nuvigil for improved wakefulness
FDA decision date: June 16 (a report of the decision may come Monday)

Nuvigil is an important second-generation version of Cephalon's wake-promoting drug Provigil, which will soon go generic. With a longer half-life, Nuvigil is expected to remain effective longer, upwards of 10 to 11 hours vs. 6 to 7 hours for Provigil. Originally approved as a treatment for narcolepsy, Provigil (and soon Nuvigil) are used more commonly to combat shift-work fatigue, excessive daytime sleepiness and for people with sleep apnea.

Neurochem (NRMX)
Drug/indication: Kiacta for amyloidosis
FDA decision date: July 16

An approval decision on Kiacta has been delayed since August 2006, when the FDA asked Neurochem for more efficacy data and indicated that the company should run another clinical trial. Neurochen chose not to do that, opting instead to give the FDA additional data from its existing clinical trial. Needless to say, Kiacta's approval -- yes or no -- is a controversial question.

Do you think it's safe to invest in biotechs ahead of FDA decisions?
Answer Here

DOR BioPharma (DORB)
Drug/indication: OrBec for graft vs. host disease
FDA decision date: July 21

When a May 9 FDA advisory panel voted to recommend against approval of OrBec, the drug's prospects took a significant turn for the worse. While the FDA doesn't always follow the advice of its panel, it's not likely to go the other way in this case.

Judgment Day
Expected FDA Decision Date Company Drug Indication
6/15/2007 Encysive Pharmaceuticals Thelin Pulmonary Arterial Hypertension (PAH)
6/16/2007 Cephalon Nuvigil Narcolepsy
6/16/2007 Cephalon Nuvigil Sleep Apnea
6/18/2007 Gilead Sciences Letairis Pulmonary Arterial Hypertension (PAH)
Now-06/30/2007 Pfizer Celsentri HIV/AIDS
7/16/2007 Neurochem Kiacta Amyloid A Amyloidosis
7/21/2007 DOR BioPharma OrBec Graft vs. Host Disease (GVHD)
7/26/2007 Sanofi-Aventis Zimulti Obesity
7/29/2007 KV Pharmaceutical Evamist Menopause
8/1/2007 POZEN Trexima Migraine Headaches
8/13/2007 Indevus Pharmaceuticals Sanctura XR Overactive Bladder
8/15/2007 GPC Biotech Satraplatin Prostate Cancer
8/26/2007 IDM Pharma Junovan Bone Cancer
8/30/2007 Tercica Somatuline Autogel Acromegaly
9/6/2007 Omrix Pharmaceuticals Thrombin Hemostasis
10/7/2007 Theravance Telavancin Skin and Skin-Structure Infections
10/15/2007 Elan/Biogen Idec Tysabri Crohn's Disease
10/18/2007 ZymoGenetics rThrombin Hemostasis
10/18/2007 Cardiome Pharma Vernakalant hydrochloride (iv) Dysrhythmia (Arrhythmia)
10/20/2007 Pfizer Lyrica Fibromyalgia
10/21/2007 Genzyme Renvela End-Stage Renal Disease (ESRD)
11/1/2007 Forest Laboratories Nebivolol Hypertension (Systemic)
11/18/2007 Basilea Pharmaceutica Ceftobiprole Skin and Skin-Structure Infections
11/24/2007 BioMarin Pharmaceutical Kuvan Phenylketonuria (PKU)
12/31/2007 Pharmacyclics Xcytrin Brain Cancer (secondary; metastases)
Source: Biomedtracker, analyst research reports

Indevus Pharmaceuticals (IDEV)
Drug/indication: Sanctura XR for overactive bladder
FDA decision date: Aug. 13

Clinical data suggests that Sanctura XR is the best drug in the overactive bladder class, which is a billion-dollar-plus market and growing. (You can't watch network news without seeing multiple ads for overactive bladder drugs.)

But therein lies the catch. Tiny Indevus and its not-so-much-bigger marketing partner Esprit Pharma have to figure out a way to convince doctors to prescribe Sanctura XR against Big Pharma competitors with very deep marketing pockets.

GPC Biotech (GPCB)
Drug/indication: Satraplatin for prostate cancer
FDA decision date: Aug. 15

Satraplatin is the first oral (pill) formulation of the commonly used platinum class of chemotherapy drugs. The phase III satraplatin study in men with advanced prostate cancer was a success, it hit all its efficacy endpoints, and data has been presented at numerous medical meetings, including this month's American Society of Clinical Oncology annual meeting.
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