Biotech Bets for 2008

With 2008 barely more than a month away, there's little upcoming action left for biotech investors this year, except for the American Society of Hematology medical conference, a few odd FDA regulatory decisions, and a couple of advisory panel hearings.

Now's the time for biotech investors to start making bets on development-stage drugmakers with important milestones coming up next year. Here are some of the more interesting biotech bets for 2008:

FDA decisions galore
The last two major important FDA decisions for young biotechs in 2007 are the December FDA decisions on the marketing applications for BioMarin's (Nasdaq: BMRN  ) enzyme-replacement therapy, Kuvan, and Neurocrine Bioscience's insomnia treatment, indiplon.

BioMarin's Kuvan application has a PDUFA target date of Dec. 14, and the FDA is expected to make a decision on indiplon Dec. 12. As Rule Breakers analyst Charly Travers pointed out, Kuvan's approval is as close to a sure thing as is possible in the unpredictable biotech sector. On the other hand, after receiving one approvable letter last year, and facing a possible request for more safety data (studies Neurocrine did not perform), the indiplon outcome is much less predictable.

The year to come
Here are the notable upcoming FDA decisions in 2008 for selected drug developers' top compounds:

Developer

Drug

Potential Indication

History

Review Date

Elan and Biogen IDEC (NASDAQ:BIIB)

Tysabri

Crohn's disease

Positive FDA advisory panel

Jan. 13

Cardiome

Intravenous Vernakalant

Acute atrial fibrillation

Two positive phase 3 trials

Jan. 19

Adolor (NASDAQ:ADLR) and GlaxoSmithKline

Entereg

Postoperative ileus

Multiple approvable letters

Feb. 10

Genentech (NYSE:DNA)

Avastin

Front-line late-stage breast cancer

FDA request for new data in 2006

Feb. 23

QLT

Aczone

Less restrictive label for acne

Approved in 2005. Not marketed due to label restrictions

March 23

Discovery Labs (NASDAQ:DSCO)

Surfaxin

Respiratory distress syndrome in premature infants

Multiple approvable letters

May 1

CV Therapeutics (NASDAQ:CVTX)

Ranexa

Front-line angina and diabetes

Positive phase 3 trial

July 27

Vanda Pharmaceuticals (NASDAQ:VNDA)

Iloperidone

Schizophrenia

Multiple phase 3 studies

July 27*

*Estimate based on a Sept. 27, 2007, NDA submission date and 10-month FDA review.

Place your bets
Interestingly, there are no sure approvals in this entire bunch, and there are sound arguments for and against the FDA approving any one of these compounds.

It's difficult at best to try to predict the outcome of an FDA regulatory decision, especially without the benefit of the data or the opinions that emerge from an advisory panel. Avastin and Vernakalant will get advisory panel hearings in December, and Entereg will get a committee meeting in January. For those drugs, at least, we'll have at least preliminary indications of the FDA's leanings.

Based on the data to date -- without the benefit of looking at the FDA briefing documents from panel hearings -- the candidates with the best odds for approval seem to be Ranexa for front-line angina and Avastin for breast cancer.

With no indication it has settled the FDA's concerns in previous approvable letters, Entereg's approval looks most in doubt. Iloperidone and Surfaxin could go either way; the former has no FDA history, while figuring out whether Discovery Labs assuaged previous FDA concerns proved a losing bet in the past.

Worth a wager?
None of the above FDA approval decisions will ultimately make or break any of the drugmakers, but the agency's decisions will have a dramatic effect on many of their share prices. Excepting Discovery Labs and Adolor, all the other drugmakers do have meaningful midstage pipelines.

Investors who wait until after an FDA decision to buy into any one of the above drugmakers should still likely be able to reap large share-price gains as sales of the drugs increase. Cautious Fools should thus consider staying away from these firms until after the FDA makes up its increasingly safety-conscious mind on their top drugs.

It's also important to remember that these are only target dates for the FDA to make a decision on these compounds. Sometimes, the agency makes up its mind well before or (as seems the case lately) well after the PDUFA target date. Be careful if you decide to play with short-term options. For more adventurous types, the share-price volatility both before and after the FDA's ruling will likely present plenty of investment opportunities on both the short and long side of things.


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