MediGene AG announces that its Marketing Authorisation Application (MAA) 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.

Dr Axel Mescheder, chief scientific officer & chief development officer of MediGene AG commented, "We are very pleased with this decision by the regulatory authorities. Veregen is the first proprietary development compound of MediGene AG, and therefore this positive assessment of the first Marketing Authorisation Applications in Europe is an important milestone for our company. Following approval and launch of Veregen in the USA, we are keen to make the product accessible to patients in Europe as soon as possible."

Veregen for the treatment of genital warts contains a defined extract from green tea leaves. MediGene acquired the basic rights to the active substance in Veregen from the Canadian company Epitome Pharma in 1999, and was solely responsible for the drug's preclinical and clinical development, as well as for the approval process.