Biotech Values

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We can take ENCY and CEPH out and then there are 8

10 Biotech Stocks Facing FDA Judgment Day
By Adam Feuerstein
Senior Writer
6/18/2007 6:46 AM EDT
URL: http://www.thestreet.com/newsanalysis/biotech/10362958.html

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)
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)
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.

DOR BioPharma (DORB)
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.

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Indevus Pharmaceuticals (IDEV)
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)
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.

In short, Satraplatin should be a slam-dunk, no-risk approval. Of course, nothing with the FDA is easy. The agency decided to hold an advisory panel meeting to discuss Satraplatin on July 24. Why the FDA made this decision is not clear, but it promises to introduce some volatility to GPC shares in advance of the Aug. 15 deadline.

Omrix Pharmaceuticals (OMRI)
Drug/indication: Thrombin for hemostasis
FDA decision date: Sept. 6

Omrix is an interesting story in that its main competitor, Zymogenetics (ZGEN) , is expecting an FDA decision on its own hemostasis drug, rThrombin, on Oct. 18.

We've got a case of dueling thrombins, which are used primarily by surgeons to stop bleeding during surgical procedures. Omrix's Thrombin is derived from human blood and the company will market the product through a partnership with Johnson & Johnson (JNJ) . Zymogenetics' rThrombin is a recombinant product, which might make it safer and easier to store and use.

Elan (ELN) and Biogen Idec (BIIB)
Drug/indication: Tysabri for Crohn's disease
FDA decision date: Oct. 15

There isn't much debate that Tysabri works in Crohn's disease. The unresolved issue is the drug's safety given the connection between Tysabri use and the often-fatal brain disorder progressive multifocal leukoencephalopathy.

Expect this topic to be a big focus of an FDA advisory panel meeting scheduled for July 31. Tysabri is already approved as a treatment for multiple sclerosis, so a second approval in Crohn's disease would be a meaningful boost for Elan and Biogen Idec.

Cardiome (CRME)
Drug/indication: Vernakalant for cardiac arrhythmias
FDA decision date: Oct. 18

After a hiccup with the first regulatory filing, Cardiome and its partner Astellas are waiting for the FDA review of the intravenous form of vernakalant, which will be used for patients suffering from acute irregular heart rhythms.

BioMarin (CRME)
Drug/indication: Kuvan for phenylketonuria
FDA decision date: Nov. 24

If approved, Kuvan would be the first effective treatment for patients with phenylketonuria, a digestive disorder in which people lack an enzyme required to break down a specific amino acid found in most protein-rich foods. As a result, PKU patients are required to follow a restrictive diet.