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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) and Elan (ELN), Cardiome (CRME) and Genentech (DNA).

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) will hear from the agency on the approvability of its insomnia drug indiplon by Dec. 12.

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

Pharmacyclics (PCYC) 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), Genitope (GTOP) or Advanced Life Sciences (ADLS) on the calendar, even though each has a drug that could conceivably receive approval this year.

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

Dendreon (DNDN) 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) 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) 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) 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) 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

Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in 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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