Pozen Pounded on FDA's Trexima Delay

 

Can Pozen(POZN) do anything right?

The Chapel Hill, N.C.-based drug company has tried three times to get three different migraine drugs approved in the U.S. Three times, the Food and Drug Administration has sent Pozen's products packing.

The first two Pozen drugs are dead; the third, Trexima, is still hanging on, but its fate remains uncertain. Thursday, the FDA said it would require Pozen and partner GlaxoSmithKline(GSK) to collect more safety data before the drug could be approved.

The bad news sent Pozen shares tumbling 45.6% to $9.49 in recent trading. Glaxo's were up 31 cents to $51.92.

Thursday, Pozen management said it would take all steps necessary -- and fast -- to satisfy the FDA's concerns so that Trexima can be resubmitted and eventually be approved. The problem is that the clock is ticking.

Trexima faces potential competition from cheaper generics entering the market toward the end of 2008. That's why an approval Thursday was so important to Trexima (and Pozen's stock price). Now, Trexima may not make it to market (if at all) before mid-2008, leaving little time for marketing partner Glaxo to get patients on the drug.

Trexima combines Imitrex, the leading migraine headache drug marketed by Glaxo, with naproxen, an over-the-counter pain reliever and anti-inflammatory drug. Naproxen, a so-called NSAID (nonsteroidal, anti-inflammatory drug), is probably best known by the brand name Aleve.

TheStreet Premium Services    For Personal Service: 877-471-2967

Jim Cramer
Jim Cramer's Action Alerts PLUS:
Trade right alongside a Wall Street pro — enjoy access to his Charitable Trust portfolio and be sent trade alerts BEFORE he makes a move. Learn More
New: ETF Profits
ETF Profits:
Get money-making ideas from the hottest investment vehicle on the planet. Our experts show you how to play various ETF sectors to help pump-up your portfolio. Learn More
OptionsProfits
OptionsProfits:
Get 50+ trade ideas a week from the industry's top options experts. Plus — exclusive commentary on market trends and essential trading tools. Learn More
Doug Kass
Real Money:
Our team of professional Wall Street Pros — including Jim Cramer, Doug Kass, and Nicholas Vardy — delivers intelligent analysis, timely trade ideas, and colorful commentary. Learn More
Stocks Under $10
Stocks Under $10:
Break into the market with small- and mid-cap stocks... all $10 or less! David Peltier tells you exactly which low-priced stocks he's buying and selling. Learn More
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
blog comments powered by Disqus
Dow Jones S&P 500 NASDAQ 10-Year Note
12,756.05 1,341.82 2,896.50 19.91
Oil *
116.67
DOWN
134.41
DOWN
10.13
DOWN
30.73
DOWN
0.56
10 Yr
1.99%
SPDR Gold
166.92
-1.04%
-0.75%
-1.05%
-2.74%
Data delayed 20 minutes

Top Stories and Tools

Brokerage Partners

After the Bell

Before the Bell

Booyah! Newsletter

ETF Daily

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

We respect your privacy.
Podcasts

Connect with TheStreet