Pozen Pounded on FDA's Trexima Delay

08/02/07 - 02:29 PM EDT

Adam Feuerstein

It's Going to Take Some Time

Forget about the fact that a new positive genotoxicity test is not a sure thing, but even if it is OK, it will still likely take Pozen until the end of the year, realistically, to submit new data to the FDA.

After that, there doesn't seem to be any reason why the agency will take less than six months to review and issue another approval decision.

With that sort of timeline, Trexima doesn't reach the market until the middle of 2008, which puts generic competition looming on the near horizon.

Sell-side analysts Wednesday were nearly unanimous in their opinion that Trexima would be approved. They were all wrong.

I spoke this morning with a hedge fund analyst who was short Pozen going into Thursday's decision because she believed safety concerns would hold up approval. Now, she wasn't counting on potential chromosome damage as being the direct cause for an FDA rejection, but she did believe that neither Pozen nor GlaxoSmithKline was completely transparent about the reasons for Trexima's first approvable letter in June 2006.

On top of that, checks she made with migraine specialists found lackluster support for Trexima. The most aggressive prescribers told her that they'd probably use Trexima in half their patients.

Overall, the analyst's survey checks found that doctors would generally prescribe Trexima to only about 25% of their patients, in part because payors were likely to saddle Trexima with a high copayment.

"Doctors are not seeing a huge need or demand for a drug like Trexima," she said, adding that after today, it seems clear that the FDA doesn't really seem to be in a rush to approve it either.

1 2 3
Next Page »
Adam Feuerstein writes regularly for RealMoney.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
Your Recent Quotes: Quote Up0 | Quote Down0
Dow S&P 500 NASDAQ
Oil*
Gold
10 Yr
0.00%
%
%
%
Data delayed 20 min
Free Newsletters from TheStreet

Cramer's Daily Booyah!
Highlights of Jim Cramer's videos
on TheStreet.com TV & his
"Mad Money" TV show.
Before the Bell
All the information you
need to position yourself
for the day ahead.
Submit
We respect your privacy.

Premium Stock Ideas
Access Action Alerts Plus to find out Cramer’s latest picks now!