NEW YORK (Reuters) – Pfizer Inc is withdrawing all of its marketing applications for its experimental antibiotic for skin infections to conduct further clinical study of the drug.
The U.S. Food and Drug Administration in December had asked Pfizer to provide more data for the drug, dalbavancin, before deciding whether to approve the medicine.
After hearing comments from regulators, Pfizer said on Tuesday it decided to conduct an additional late-stage study of dalbavancin and withdraw applications for the product in the United States and Europe.
Pfizer has been developing dalbavancin for treating adults with complicated skin and skin structure infections caused by bacteria including methicillin-resistant Staphylococcus aureus, or MRSA, which can be tough to treat and potentially dangerous.
Pfizer estimated the phase 3 trial for dalbavancin would take about 18 months to complete but did not specify when the study will start. Assuming the results are favorable, the company would resubmit the product to various regulatory agencies.
The company said it is also planning a pediatric program for dalbavancin.
Pfizer acquired dalbavancin in 2005 as part of its purchase of Vicuron Pharmaceuticals.
Cowen and Co has estimated the drug could generate $250 million in annual sales by 2012.
Pfizer shares fell 24 cents, or 1.3 percent, to $18.90 in morning trading on the New York Stock Exchange. The shares were also down as traders in Europe cited market talk of takeover interest by Pfizer in Germany’s Bayer AG.
(Reporting by Lewis Krauskopf; Editing by Derek Caney and Steve Orlofsky)