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Pfizer says FDA rejects osteoporosis drug

September 13, 2005

NEW YORK (Reuters) – Pfizer Inc. on Tuesday said U.S.
regulators denied approval of its experimental osteoporosis
drug Oporia, handing the world’s biggest drug maker another
setback in its efforts to bring lucrative, new medicines to
market.

Pfizer said it will review its submission with the Food and
Drug Administration and was considering possible courses of
action.

“This is most concerning as it’s the third late-stage
failure they’ve had in the past year,” said A.G. Edwards
analyst Albert Rauch, who had expected Oporia, or lasofoxifene,
to generate peak annual sales of $1 billion.

Rauch said Oporia had been expected to be one of the major
drug launches between now and next year.

Natexis Bleichroeder analyst Jon LeCroy trimmed his 2008
and 2009 earnings estimates by 2 cents each based on the
assumption that Oporia won’t get approved in the U.S. or
Europe.

Pfizer issued a brief, two-paragraph statement on the FDA’s
rejection and a company spokeswoman declined to comment on the
agency’s particular concerns with the drug, which it developed
along with Ligand Pharmaceuticals Inc..

Rauch said Pfizer’s brevity could indicate more complicated
problems than merely fixing a couple things and refiling the
application.

Pfizer in December submitted a supplemental application for
Oporia as a treatment for vaginal atrophy, whose symptoms
include dryness, burning, itching and soreness.

That submission is linked to the first, but absent any
communication from the FDA, the second submission is still
pending, a company spokeswoman said.

Oporia belongs to a class of drugs known as selective
estrogen receptor modulators. They are sometimes called
“designer estrogen” since they can act like hormone replacement
therapy.

Osteoporosis causes a progressive decrease in the density
of bones, which makes them weak and more likely to fracture.

The only such drug currently on the market for the
condition, which affects 8 million women and 2 million men in
the United States, is Eli Lilly and Co.’s Evista, which Rauch
estimates will have $1 billion in sales this year.

Lilly is expected to launch a second-generation version in
2008, and Wyeth is developing a similar product with an
anticipated launch in 2007.

“Near-term it’s a positive for Lilly and will make it
easier for Wyeth because they won’t have someone launching
right in front of them,” Rauch said of the Oporia rejection.

Pfizer shares closed down 36 cents, or 1.4 percent, at
$25.98 on the New York Stock Exchange.




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