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GEN News Highlights : May 10, 2010

GC-Rise and JS Bio Pharm Sign Separate Agreements for MediGene’s Genital Warts Treatment

Launch of Veregen in South Korea and China is anticipated in 2012 and 2013, respectively.

MediGene granted GC-Rise and JS Bio Pharm separate licenses for the commercialization and marketing of its U.S.-approved genital warts treatment, Veregen®, in China and South Korea. MediGene stands to earn development- and approval-related milestones as well as royalties.

Specialty pharmaceuticals company GC-Rise will take on clinical development of Veregen in China and has responsibility for all regulatory and approval processes in its home country. In return MediGene will receive an undisclosed up-front payment and milestones on initiation of the first clinical trial in China. The firm will also profit from the supply of Veregen to GC-Rise. Market launch in China is expected at the end of 2013, the firm says.

The new South Korean licensee, JS Bio Pharm, is a specialized distributor of pharmaceuticals, particularly European originals in the dermatology and respiratory fields. Under the Veregen deal the firm will be responsible for all regulatory processes in South Korea. MediGene will receive a sales-related milestone and royalties and will also supply the drug to its partner. Launch of Veregen in South Korea is expected during 2012.

Veregen is a topical treatment for genital warts that comprises a catechin concentrate. The drug is already available in the U.S. and Germany, and launch in Austria is planned for later this year. Germany will act as the reference member state for negotiating approval in other European countries through the European Mutual Recognition procedure.

MediGene says a new wave of European marketing applications is planned during the second half of 2010. The company already has marketing partners in place for Veregen in other countries. These include Nycomed for the U.S. and Abbott Arzneimittel (previously Solvay) for Germany, Austria, and Switzerland. Other Veregen partnerships are also in place for Switzerland, Spain, Portugal, Israel, Greece, and Cyprus.