This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Setback for AstraZeneca Drug

Updated from 10:04 a.m. EDT

A staff report by the Food and Drug Administration raised significant concerns Thursday about liver damage stemming from long-term use of an experimental drug made by AstraZeneca (AZN).

The staff report, issued a day before an FDA advisory committee meets to discuss the experimental blood thinner Exanta, could be a serious blow for the U.K.-based drug company.

The FDA staff report's documents on safety and efficacy on Exanta "look downright bad," said Dr. Tim Anderson, a drug industry analyst for Prudential Equity Group, in a research report to clients Thursday. "Prior to seeing the documents, we had forecasted odds of approval at 60/40. The odds may now be lower."

Anderson said his sales forecasts for Exanta are well below the Wall Street consensus, and "now even our estimates feel too high." He predicts Exanta's sales in 2008 will be $825 million vs. the consensus view of $1.6 billion. "Even if this drug gets approved, it is very likely that few physicians will use it unless additional clinical trial work were to show better results," he added.

AstraZeneca's stock was down $1.90, or 4%, to $45.15

AstraZeneca is seeking FDA approval for Exanta for three uses: preventing blood clots in veins for patients undergoing knee replacement surgery; preventing stroke and other clot-induced complications of the erratic heartbeat disease called atrial fibrillation; and long-term prevention of blood clots in veins after a patient has gotten a standard blood clot treatment.

AstraZeneca began marketing Exanta in Germany on June 21, having secured European Union regulatory approval in late 2003 for preventing blood clots in patients who had undergone elective hip or knee replacement surgeries. This is a narrow use of the drug, but it's also one for which liver problems would be less likely to arise because patients won't take the drug for a long time. The EU approval calls for the drug to be administered orally for 11 days.

The FDA staff report on Thursday indicated that there didn't appear to be any risk of liver damage -- measured by an increase in a liver enzyme -- during short-term use of Exanta. Short-term use is defined as less than 12 days.

But the agency also noted that company-sponsored tests of the drug during knee replacement surgery -- for which the drug would be used short term -- also revealed that elevated enzymes showed up in some patients six weeks after surgery. "Whether delayed onset of severe liver injury after short-term ... treatment could occur is unknown, since no additional routine study visits were conducted," the FDA said.

1 of 2

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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!


DOW 18,053.71 +23.50 0.13%
S&P 500 2,088.77 +6.89 0.33%
NASDAQ 4,806.8590 +33.3870 0.70%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

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