This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Pozen Pounded on FDA's Trexima Delay

Can Pozen (POZN - Get Report) 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 - Get Report) 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.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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.
Submit an article to us!

Markets

DOW 17,461.51 -217.19 -1.23%
S&P 500 2,042.01 -15.08 -0.73%
NASDAQ 4,719.1180 -52.6450 -1.10%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs