Biotech Stocks Face Make-or-Break FDA Rulings

With the year coming to a close, it's time to look ahead to the events that will move biotech stocks in 2008. For starters, I've put together a calendar of expected Food and Drug Administration approval decisions.

This list for 2008 mimics the calendar I put together last June for the rest of this year. There's some overlap across the two, because a handful of expected 2007 approval decisions were pushed back to January and February 2008. These include drugs from Biogen Idec(BIIB Quote) and Elan(ELN Quote), Cardiome(CRME Quote) and Genentech(DNA Quote).

Before I highlight some of the 2008 FDA drug-approval events, don't forget that there are a few outstanding decisions expected before the end of December.

Neurocrine BioSciences(NBIX Quote) will hear from the agency on the approvability of its insomnia drug indiplon by Dec. 12.

BioMarin Pharmaceuticals(BMRN Quote) is awaiting word from the FDA by Dec. 14 on Kuvan, for the treatment of phenylketonuria.

Pharmacyclics(PCYC Quote) and its cancer drug Xcytrin expect an FDA decision by Dec. 31.

OK, onward to 2008. I have tried to be comprehensive, but I'm sure there are drugs omitted, so my apologies in advance. Much credit for this calendar must go to Sagient Research and its BioMedTracker Web site -- a very handy and comprehensive tool for keeping track of biotech and drug catalysts.

I omitted drugs from the list that haven't yet been formally submitted to the FDA for approval. That means you wont find companies like Medarex(MEDX Quote), Genitope(GTOP Quote) or Advanced Life Sciences(ADLS Quote) on the calendar, even though each has a drug that could conceivably receive approval this year.

(ImClone Systems(IMCL Quote) is in this category as well, if the company files Erbitux for an expanded lung cancer label soon.)

Dendreon(DNDN Quote) is not on the list because pivotal data from its prostate cancer drug Provenge isn't expected until the second half of 2008. That makes a 2008 approval very unlikely, even if the data are positive.

Some of the highlights coming in the new year:

Discovery Labs(DSCO Quote) will look for redemption in May when the FDA makes a decision on Surfaxin for the treatment of infantile respiratory distress syndrome. Management screw-ups and manufacturing problems have significantly delayed the Surfaxin program, so this may be Discovery's last shot at a turnaround.

Indevus Pharmaceuticals(IDEV Quote) should be able to make a big dent in the growing "manopause" market with its long-acting testosterone replacement therapy, Nebido. The FDA decision date is June 27.

Johnson & Johnson(JNJ Quote) won't be the only company affected on Aug. 28 when the FDA decides the approvability of paliperidone palmitate for the treatment of schizophrenia. Look for volatility in Alkermes'(ALKS Quote) shares as well, because the drug-delivery firm stands to lose key revenue if "PP" is approved.

Biotech's 2008 Judgment Days Companies and their drugs facing the FDA next year
Expected FDA decision date	Company	Drug	Indication
1/13/2008	Biogen Idec/Elan	Tysabri	Crohn's Disease
1/17/2008	ZymoGenetics	rThrombin	Hemostasis
1/18/2008	Johnson & Johnson	TMC125	HIV/AIDS
1/19/2008	Cardiome Pharma	Vernakalant IV	Acute atrial fibrillation
1/30/2008	Progenics Pharmaceuticals	Methylnaltrexone	Opioid Induced Constipation
1/30/2008	Lev Pharmaceuticals	Cinryze	Hereditary angioedema (HAE)
2/2/2008	Abbott Labs	Humira	Psoriasis
2/10/2008	Adolor	Entereg	Postoperative Ileus
2/23/2008	Genentech	Avastin	Breast Cancer
3/7/2008	Spectrum Pharmaceuticals	ISO-Vorin	Bone Cancer
4/15/2008	POZEN	Trexima	Migraine Headaches
4/29/2008	Jerini	Icatibant	Hereditary angioedema (HAE)
02/01/2008-04/30/2008	Axcan Pharma	Ultrase Capsules	Exocrine Pancreatic Insufficiency
5/1/2008	Discovery Laboratories	Surfaxin	Respiratory Distress Syndrome (RDS)
05/01/2008-05/15/2008	The Medicines Company	Cleviprex	Hypertension (Systemic)
04/01/2008-05/31/2008	Merck & Co.	Cordaptive	Dyslipidemia/Hypercholesterolemia
6/27/2008	Indevus Pharmaceuticals	Nebido	Hypogonadism
End of March 2008	Cephalon	Treanda	Chronic Lymphocytic Leukemia (CLL)
7/27/2008	MGI Pharma	Aquavan	Anesthesia
7/27/2008	Vanda Pharma/ Titan Pharma	Iloperidone	Schizophrenia
8/11/2008	Gilead Sciences	Viread	Hepatitis B
08/01/2008-08/24/2008	Amgen	Romiplostim	Immune Thrombocytopenic Purpura (ITP)
8/29/2008	Johnson & Johnson	Paliperidone palmitate	Schizophrenia
8/31/2008	BioDelivery Sciences Int'l	BEMA Fentanyl	Pain Indications
9/16/2008	Gilead Sciences	Aztreonam lysine	Cystic Fibrosis
Source: BioMedTracker, company reports