MediGene receives Positive Assessment on Market Authorisation for Veregen in First European Countries

14-Jul-2009 - Germany

MediGene AG announces that its Marketing Authorisation Application for the medicinal product Veregen® (formerly Polyphenon E® Ointment) for the treatment of genital warts has been assessed positively by the national regulatory authorities of Germany, Austria, and Spain. This binding decision guarantees that national Marketing Authorisations in these countries will be formally granted by the authorities within the next few months. The Marketing Authorisation of Veregen® in Germany, the Reference Member State in this Decentralized Procedure, shall provide the basis for additional Marketing Authorisations in other European countries via the Mutual Recognition Procedure.

MediGene is planning commercialization of Veregen® in Germany and other European countries via distribution partners. In the USA, Veregen® is already marketed by MediGene's licensee Nycomed US, Inc. MediGene has recently announced the conclusion of an agreement with the Spanish company Juste S.A.Q.F. for the distribution of Veregen® in Spain and Portugal.

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