This Day On The Street
Continue to site
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

Setback for AstraZeneca Drug

But the big market for Exanta and AstraZeneca will be in chronic uses, such as atrial fibrillation or the installation of a mechanical heart valve. These patients would have to take Exanta for the rest of their lives. AstraZeneca is seeking European Union approval for expanded applications of the drug.

The FDA "will likely restrict access to this drug, and probably deservedly so," said Anderson, who has a neutral rating on the stock. (He doesn't own shares of AstraZeneca, and his firm doesn't have an investment-banking relationship with the company.)

Anderson also noted than one FDA reviewer questioned whether Exanta is better than a placebo in terms of efficacy for preventing blood clots in patients with atrial fibrillation. He said the viewer also questioned whether Exanta is better than today's primary pill, which is sold generically as Warfarin and under the brand name Coumadin.

Much of the FDA staff report focused on potential liver damage, as measured by significant increases of an enzyme called ALT. The prospect of liver damage is a key issue in the FDA's evaluation. The agency is bound to be cautious because some drugs with lower liver-damage test results than Exanta's have been approved, only to be withdrawn later by manufacturers, says a recent research report by Bear Stearns.

The FDA says that drug-induced liver injury is the top cause of acute liver failure, a rare disease that can produce critical illness in a few days, cause death or necessitate a liver transplant. It's the leading reason why drugs are removed from the market and why the FDA requires restricted use of certain drugs and special monitoring of patients.

The FDA staff report Thursday said the severity and rate of liver toxicity "is substantial with long term treatment" of Exanta, adding that preliminary analyses "suggest the risk of severe liver injury begins within the first month of therapy."

The FDA staff report noted that AstraZeneca had submitted a plan for monitoring potential liver damage from Exanta, but the report said the plan "does not address the possible risks" of delayed liver toxicity after short-term use of Exanta or the risk of heart attack that an FDA report on clinical safety had detected. In addition, reversal of Exanta-induced bleeding "was not addressed by the sponsor," the staff report said.

The staff report recommends that the advisory committee ask a lot of questions on Friday, including whether more tests are needed to assess liver toxicity and the risk of heart attack, as well as the crucial question: Do the benefits exceed the risk?

The FDA is expected to act on AstraZeneca's request in late October. The agency doesn't have to follow its advisory committee's recommendations, but it usually does so.

Depending on how well Exanta performs, Merck (MRK - Get Report)could get a royalty of as much as 20% of sales. That's the residue of a joint venture that Merck formed in 1994 with then independent Astra. The joint venture was restructured into a partnership in 1998, and the partnership was restructured after Astra merged with Britain's Zeneca in 1999.
2 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr 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

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AZN $34.11 0.00%
MRK $53.72 0.00%
AAPL $118.03 0.00%
FB $105.41 0.00%
GOOG $748.15 0.00%


Chart of I:DJI
DOW 17,813.39 +1.20 0.01%
S&P 500 2,088.87 -0.27 -0.01%
NASDAQ 5,116.1430 +13.3350 0.26%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs