Pfizer Drug Conditionally Cleared

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Pfizer Drug Conditionally Cleared

By Steyer

TheStreet.com Staff Reporter

12/6/2005 6:38 PM EST

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Pfizer (PFE:NYSE - commentary - research - Cramer's Take) 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.