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UPDATE 1-Wyeth puts off European OK for depression drug

Wed Oct 15, 2008 9:35am EDT

(New throughout; adds NEW YORK to dateline)

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NEW YORK, Oct 15 (Reuters) - Wyeth WYE.N has decided against pursuing European approval for its depression treatment for now after consulting with regulators, the company said on Wednesday.

The drug maker had said earlier this year that the Committee for Medicinal Products for Human Use raised concerns about the effectiveness of the medicine, known as desvenlafaxine.

The drug is already sold in the United States under the brand name Pristiq, but expectations for the drug have dimmed amid questions about its ability to distinguish itself in the crowded market for depression treatments.

Wyeth is counting on Pristiq to help offset impending generic competition to its blockbuster anti-depressant Effexor, of which Pristiq is a derivative.

The New Jersey-based drug maker said it remains committed to making desvenlafaxine available to patients with depression around the world, including in Europe.

Wyeth decided against pursuing approval for now for "strategic reasons" and clinical studies for the drug are ongoing, spokeswoman Gwen Fisher said.

"We're assessing a variety of options," Fisher said.

The drug is also approved in Australia and Brazil, while applications are pending in 22 other markets.

In July, Wyeth's head of pharmaceuticals said U.S. insurers have been more reluctant than expected to reimburse patients for Pristiq, which hit U.S. drug stores in May, but the company stuck to its forecast of eventual $1 billion-a-year sales for the product.

The U.S. Food and Drug Administration also has been unwilling to approve Pristiq as a treatment for postmenopausal hot flashes until Wyeth resolves concerns about its potential to cause serious heart and liver problems.

Wyeth shares were down 0.9 percent at $33.20 in early trading on the New York Stock Exchange.

(Reporting by Lewis Krauskopf, editing by Dave Zimmerman)



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