PFPC Daily - January 20, 2005

Pfizer Gets European Request for More Celebrex Data

Jan. 20 (Bloomberg) -- European health regulators asked Pfizer Inc.,
the world's biggest drugmaker, for more information from a study that
linked its Celebrex painkiller to heart-attack risk.

The request by the European Medicines Agency was part of its safety
review of drugs in the same class as Merck & Co.'s Vioxx, the agency
said today in an e-mailed statement. The EMEA, which began the review
in October after Merck recalled Vioxx because of a link to heart
attacks and strokes, analyzed data and met with company
representatives over four days this week.

New York-based Pfizer last month said a study of Celebrex's ability
to prevent colon growths found that higher doses more than doubled
the risk of heart attacks. U.S. regulators scheduled three days of
hearings next month by an advisory committee on the safety of
painkillers in the same category.

``We need to understand what are the issues behind this increase in
cardiac risk,'' agency spokesman Martin Harvey said in a telephone
interview. ``We've asked them to analyze the data, clarify the
presentation of data and come back to us and give their view of what
the data means and how to interpret it.''

EU health regulators are asking Pfizer for ``clarifications and
analyses'' of the data, the agency said. The agency is a centralized
body of the EU and has a network of about 3,000 European experts that
conduct the scientific work of the agency and its committees.

Cox-2 Reviews

Voicemail messages left for Pfizer spokeswomen Mariann Caprino and
Susan Bro by Bloomberg News weren't returned. Joel Morris, a
spokesman for Pfizer in the U.K., didn't respond to a telephone call
with a comment.

Shares of New York-based Pfizer rose 2 cents to $24.90 as of 3:15
p.m. in New York Stock Exchange composite trading. They dropped 24
percent last year.

Vioxx generated $2.5 billion in sales in 2003. Celebrex had sales of
$3.3 billion in 2004 and Bextra sales were $1.3 billion.

The European agency's review also includes Merck's Arcoxia, Novartis
AG's Prexige and Pfizer's Bextra. Like Vioxx and Celebrex, all of
them were designed to treat arthritis by inhibiting the body's
production of the Cox-2 enzyme, which is linked to pain and swelling.

The review is to determine whether regulators should increase
warnings, restrict uses or make other changes for the painkillers'
approved labels in the European Union. The agency will continue the
review at its meeting from Feb. 14 to Feb. 17, it said today.

In the U.S., the Food and Drug Administration's panel will review
painkillers in meetings Feb. 16-18 in Gaithersburg, Maryland.

Pfizer agreed not to introduce a high-dose version of Celebrex called
Onsenal, which is used to treat a form of colon polyps that can turn
cancerous. The drug is already approved in the EU for the indication.

SOURCE:
http://www.bloomberg.com/