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Pfizer Asks FDA for Approval of New Cancer Drug

Posted on: Wednesday, 10 August 2005, 21:00 CDT

Aug. 11--Pfizer Inc. submitted a promising new cancer drug Wednesday to the federal Food and Drug Administration.

Industry analysts say the new drug could be a revolutionary way to treat gastrointestinal and kidney-related cancers.

FDA officials have already said they will grant the new drug, known as Sutent, "fast track" review status because of its significant benefit over existing therapies for serious or life-threatening cancer illnesses.

The Sutent application is indicative of the New York-based pharmaceutical company's desire to bolster its portfolio of drugs that treat various cancers. Pfizer officials have said such oncology drugs have become a new "research priority" for the world's largest pharmaceutical company.

Pfizer, which has extensive operations in Groton and New London, has devoted a significant amount of its research and development funds -- which this year will reach an industry record of some $8 billion -- toward the development of drug therapies to treat breast, colo-rectal and other cancers.

Investors and analysts have been following the development of Sutent along with those in the oncology field, who treat cancers. Yet the news about Pfizer's new drug application to the FDA had little effect among Wall Street traders on Wednesday, where Pfizer shares closed the day's trading on the New York Stock Exchange at $26.39 a share, down 12 cents from the prior day's closing price.

Over the past year, Pfizer's shares, which are one of the 30 stocks that make up the bellwether Dow Jones Industrial Average, have seesawed between a low point of $21.99 a share and a high of $33.05 a share.

Sutent, which is taken orally, is considered a multi-targeting cancer drug that can stop the blood supply to tumor cells as well as directly attack those cells. During Pfizer's clinical trials for the proposed new cancer drug, more than 2,000 patients received Sutent for their illnesses.

In February, the financial press reported that a clinical trial was stopped early because the drug had proved its effectiveness sooner than expected.

Pfizer officials have said that Sutent also is under consideration for use, either alone or in combination with other medications, for treatment of breast cancers, as well as lung, prostate and colo-rectal cancers.

The drug also is considered to be the first in a class of new drugs that selectively target multiple protein receptors, which is believed to help starve tumors of both blood and nutrients needed for their growth and at the same time kill the cancer cells that make up those tumors.

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PFE,

Source: The Day

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