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UPDATE 2-Pfizer pulls EU bid to sell non-prescription Viagra

Thu Nov 20, 2008 7:25am EST

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*Withdraws EU application for non-prescription Viagra

Stocks  |  Regulatory News

*Still believes 50mg dose meets guidelines for OTC status (Adds analyst comment, recasts)

LONDON, Nov 20 (Reuters) - Pfizer Inc (PFE.N) has pulled its bid to make its blockbuster impotence pill Viagra available in the European Union without prescription, the company said on Thursday.

Pfizer withdrew its request to sell Viagra over the counter in 50 milligram doses following comments it received from the European Medicines Agency, which was weighing the application on a drug that last year generated sales of $1.76 billion.

In a statement the company said it pulled the application "recognizing that there were some concerns regarding the proposed supply of Viagra 50 milligram tablets without a prescription in the European Union."

Pfizer said it believed that dose of Viagra still meets guidelines for a switch to non-prescription, and that it would continue to work with regulators to improve access to the drug and other medicines.

Peter Cartwright, an analyst at Evolution Securities, said the decision would not likely have a big impact on Pfizer, and that the decision indicates the company may have met more regulatory resistance than expected.

"It's a commercial decision," he said. "If the aggravation is too much, put your efforts elsewhere."

Impotence is a common condition worldwide, and drugs like Pfizer Inc's Viagra or sildenafil, Eli Lilly and Co's (LLY.N) Cialis or tadalafil, and Bayer AG's BAYG.DE Levitra or vardenafil, work by increasing blood flow to the genitals.

Pfizer has not filed an application with U.S. regulators to make Viagra available over the counter in the United States, the world's biggest drug market.



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