Bradley/MediGene AG's Polyphenon E ointment has a new user fee date of Oct. 31, 2006, Bradley said June 30.

The three-month extension is "a result of the FDA classification as a major amendment [of] certain documents submitted by MediGene, which were requested earlier by the FDA," Bradley said.

Polyphenon E, an extract from green tea leaves, is intended for treatment of external genital warts. In the second of two Phase III studies, Polyphenon E 10% cleared all baseline warts and new warts in 57% of patients, while Polyphenon E 15% cleared most or all genital warts in 78% of patients.

Polyphenon E is also being evaluated for actinic keratoses; that indication is currently in Phase II trials.

Polyphenon E User Fee Date Extended To October

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