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|
|1/18/2008||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)|
|3/7/2008||Spectrum Pharmaceuticals||ISO-Vorin||Bone Cancer|
|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|
|End of March 2008||Cephalon||Treanda||Chronic Lymphocytic Leukemia (CLL)|
|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|
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