BioWorld International Correspondent

Billing the event as the first-ever U.S. product approval for a German biotechnology company, MediGene AG gained a green light from the FDA for its genital warts treatment, Polyphenon E ointment.

The marketing authorization triggers a $14 million milestone payment from MediGene's U.S. marketing partner, Fairfield, N.J.-based Bradley Pharmaceuticals Inc., which is due to launch the product in the second half of next year.

"The process is ready, but the upscaling isn't ready yet," MediGene spokesman Georg Dönges told BioWorld International.

Polyphenon E contains a mixture of naturally occurring catechin molecules with antioxidant properties, which are derived from an extract of green tea leaves. The extracts are supplied by Mitsui Norin Pharmaceutical Co. Ltd., a Tokyo-based company that originally discovered the therapeutic benefits of tea catechins in the 1980s.

MediGene licensed the compound from Mitsui Norin licensee Epitome Pharmaceuticals Ltd., of Halifax, Nova Scotia, in 1999. C.P.M. Contract Pharma GmbH & Co. KG, of Feldkirchen-Westerham, Germany, produces the finished product on behalf of MediGene.

MediGene has forecast peak sales of $100 million in the U.S. Polyphenon E, which gained approval under the brand name Veregen, will compete directly in the U.S. with Aldara (imiquimod), a topical immune response modifier, marketed by St. Paul, Minnesota-based 3M Co. "We think our product is better because it has a lower recurrence rate," Dönges said.

Although the two products have not been compared in a head-to-head study, MediGene quoted a recurrence rate of 6.2 percent for Polyphenon E vs. a rate of 13 percent to 27.5 percent for Aldara. It also claimed higher efficacy levels, with complete clearance in 64.9 percent of cases vs. 50 percent for Aldara.

Approval was granted on Oct. 31, following a 90-day extension to the original PDUFA date of July 28. That forced Martinsried, Germany-based MediGene to revise downward its financial forecast for the year, although Dönges said the company would issue new financial guidance today. (See BioWorld International, July 6, 2006.)

The company also is finalizing its application for approval in Europe, which it expects to file before the year end. It already has one marketed product in Europe, Eligard, a hormonal treatment for advanced prostate cancer, which is marketed by Tokyo-based Astellas Pharma Inc.

It will decide how to commercialize Polyphenon E next year, Dönges said. It is in discussions with potential partners but may opt to market the product itself.

"Generally, if you decide to build your own distribution network, it's not a cheap solution unless you can get together with someone who has more products," Robert Willis, head of research at Viscardi Securities Wertpapierhandelsbank GmbH, of Munich, told BioWorld International.