SEC Asking Pfizer for Bextra, Celebrex Data

SEC Asking Pfizer for Bextra, Celebrex Data

By MADLEN READ
The Associated Press
Tuesday, August 9, 2005; 12:55 PM

NEW YORK -- Pfizer Inc. is responding to a request from the Securities and Exchange Commission for information and documents on its Bextra and Celebrex painkillers, the drugmaker said Tuesday in a filing.

The SEC made the request in the second quarter, said Pfizer spokeswoman Mariann Caprino. She said the company has no further comment on the request, except that it is cooperating.


New York-based Pfizer, the world's biggest drugmaker, had received similar requests for information and documents from the Department of Justice and a group of state attorneys general about Bextra and Celebrex, which along with Merck & Co.'s painkiller, Vioxx, are known as Cox-2 inhibitors.

In September, Whitehouse Station, N.J.-based Merck withdrew Vioxx from the market after it said the drug was associated with higher rates of heart attacks and strokes in patients who took it for more than 18 months.

In April, Pfizer's Bextra was pulled from the market because of safety risks. The U.S. Food and Drug Administration also ordered Pfizer and 19 other popular prescription competitors to provide stronger warnings about possible cardiovascular risk in pain relievers.

The SEC request did not come as a surprise to analysts, who characterized it as yet another step in the ongoing investigation of Cox-2 inhibitors.

Caris & Co. analyst Le Anne Zhao said Pfizer will likely keep working with government officials on the Celebrex label. Bextra probably won't return to the market "until more studies have been done to show risk factors," Zhao said.

Also in Pfizer's filing Tuesday, the company said the U.S. Environmental Protection Agency in July proposed a civil penalty of $275,000 to settle alleged violations of the Federal Clean Air Act at the company's Kalamazoo, Mich., facility.

Pfizer said it is in discussions with the EPA to resolve the matter and is addressing the agency's concerns.

Pfizer's filing also noted the Internal Revenue Service has begun an audit of the company's returns for 2002 and 2003.

In midday trading, shares of Pfizer rose 26 cents to $26.47 on the New York Stock Exchange.