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 Quote)
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 Quote)
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 Quote)
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 Quote)
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 Quote)
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.