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Pfizer ends cholesterol drug development 57 minutes ago

NEW YORK - Pfizer Inc. said Saturday it has cut off all clinical

trials and development for a cholesterol drug that was supposed to be

the star of its pipeline because of an unexpected number of deaths

and cardiovascular problems in patients who used it.

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The world's largest drugmaker said it was told Saturday that an

independent board monitoring a study for torcetrapib, a drug that

raises levels of HDL, or what's commonly known as good cholesterol,

recommended that the work end because of " an imbalance of mortality

and cardiovascular events. "

Pfizer said it is asking all clinical investigators conducting trials

to warn patients to stop taking the drug immediately.

The news is devastating to Pfizer, which had been counting on the

drug to revitalize stagnant sales that have been hurt by numerous

patent expirations on key products.

Just two days ago, Pfizer had said it hoped to file an application

with the Food and Drug Administration for approval of

torcetrapib by the second half of next year. But on Saturday, the

company said the loss of the drug will not affect its financial

guidance for 2006.

New York-based Pfizer had expected to sell Torcetrapib in combination

with Lipitor, which lowers bad cholesterol and is the

company's — and the world's — best-selling drug.

According to Pfizer spokesman Fitzhenry, 82 patients taking the

combination of torcetrapib died, compared to 51 deaths in the arm of

the study where patients were taking Lipitor alone. Each arm of the

study had 7,500 patients. Pfizer said that the study didn't raise any

questions about Lipitor's safety.

There already had been concerns about Torcetrapib because a study

showed it caused an increase in blood pressure. In raising its

earnings guidance for the year Thursday the company emphasized that

it has 242 research programs and other promising drugs in the

pipeline, but analysts remained focused on Torcetrapib and said

Pfizer would struggle without it.

Patent expirations will cost the company $14 billion in annual sales

between 2005 and 2007, the company said. Lipitor, which had $12.2

billion in sales last year, may lose patent protection by 2010.

Dr. Philip Barter, chairman of the steering committee overseeing the

study, said in Pfizer's release that the findings of the data safety

monitoring board Torcetrapib were a surprise " in light of prior study

results. "

" We believed that the study was coming along as expected, and this

new information was totally unexpected and disappointing, given the

potential benefits of this drug, " said Barter, Director of the Heart

Research Institute in Australia.

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