FDA Decision on New Wyeth Drug Postponed

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FDA Decision on New Wyeth Drug Postponed

(April 19, 2007) -- Pharmaceutical maker Wyeth said Thursday regulatory approval of a new drug to treat menopause symptoms won't happen until at least July, several months later than expected.

The Food and Drug Administration was scheduled to make a decision next week on Pristiq, the first non-hormonal drug to treat hot flashes and other menopausal symptoms.

During an earnings teleconference Thursday, Wyeth told investors and analysts the decision had been postponed until the FDA can review additional data Wyeth submitted.

The new data show that lowering Pristiq's dosage lessens side effects, including nausea, which would make the drug safer and more appealing to patients, Wyeth Vice President Joe Mahady said during the call.

Morgan Stanley analyst Jami Rubin suggested the net impact of Wyeth's update was more negative than positive.

"Delays on new product approvals, despite compelling data releases, overshadowed the strong quarter," Rubin wrote Thursday in a brief research note.

Pristiq is a derivative of the primary ingredient in Wyeth's top-selling depression treatment Effexor, which loses patent protection in 2010.

Drug companies routinely patent new versions of successful drugs as they approach patent expiration in an effort to extend the drug's revenue stream.

Wyeth is hoping to get FDA approval to market Pristiq as a treatment for depression in older women and menopause symptoms.

The company's announcement Thursday also means the FDA's review of Pristiq as a depression treatment will be delayed. If approved, marketing Pristiq for depression won't happen until the first part of 2008, the Madison, N.J.-based company said Thursday.

Shares of Wyeth fell 46 cents Thursday to $55.87 in mid day trading on the New York Stock Exchange.

By MATTHEW PERRONE AP Business Writer
Source: The Associated Press

Last updated: 04/07

FDA Decision on New Wyeth Drug Postponed

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