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

Pfizer Drug Conditionally Cleared

Pfizer (PFE - Get Report) has received conditional approval from the Food and Drug Administration for a new fungal infection drug, but the company declined to say what the conditions are or how long it will take to meet those requirements.

The drug, called anidulafungin, is designed to fight fungal infections that affect the skin or mucous membrane but that also can enter the bloodstream and damage the heart. Pfizer initially asked the FDA to approve the drug for fungal infections of the esophagus.

The FDA was scheduled to act in late November, but the company didn't announce the agency's response. A Pfizer spokesman on Tuesday confirmed that his company received an "approvable letter" from the FDA on Nov. 25, indicating the agency wanted more information. He declined to comment on the requirements.

Anidulafungin is one of two anti-infectives that were in late-stage development at Vicuron Pharmaceuticals when Pfizer offered $1.9 billion for the company on June 16. The deal closed Sept.14.

The other Vicuron product, the antibiotic dalbavancin, also received conditional approval from the FDA. The agency had been scheduled to act in mid-September. Pfizer confirmed in its third-quarter financial report issued Oct. 20 that it had received conditional approval. Dalbavancin treats dangerous hospital-based infections featuring bacteria that have become resistant to other antibiotics.

At the time, Pfizer declined to provide details about the requirements or a timetable, saying only that "we anticipate a rapid and successful resolution of outstanding issues."

Pfizer acquired Vicuron in order to bolster its collection of infection-fighting drugs that produced $4.72 billion in sales last year, or 9% of corporate revenue.

However, the antifungal Diflucan, which had $945 million in sales last year, lost U.S. patent protection in July 2004 and is being battered this year. For the first nine months of 2005, Diflucan produced $370 million in sales vs. $805 million for the same period last year.

Generic competition is expected to take a greater toll on the antibiotic Zithromax, which is used primarily for respiratory infections. That drug lost U.S. patent protection last month. Last year, its worldwide sales were $1.85 billion.

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
PFE $32.79 0.00%
AAPL $117.81 0.00%
FB $105.45 0.00%
GOOG $750.26 0.00%
TSLA $231.61 0.00%


Chart of I:DJI
DOW 17,798.49 -14.90 -0.08%
S&P 500 2,090.11 +1.24 0.06%
NASDAQ 5,127.5250 +11.3820 0.22%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs