The biotech company MediGene AG (Frankfurt, Prime Standard) announces that Veregen has obtained market approval from the Spanish regulatory authority (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS), for the treatment of genital warts.
Market launch of Veregen in Spain by MediGene’s partner Juste S A Q F is scheduled to take place in the first quarter of 2012, upon conclusion of the price fixing procedure, which is conducted in conjunction with the Dirección General de Farmacia y Productos Sanitarios.
Veregen is currently available on the US, German, and Austrian markets. A second wave of applications for market approval within the European mutual recognition procedure is planned, with Germany serving as the reference member state in this process.
MediGene has already entered into several marketing partnerships for Veregen, eg with Nycomed for the US, with Abbott for Germany, Austria, and Switzerland, with Laboratoires Expanscience for France, and with a number of other partners across Europe, Latin America, and Asia. MediGene is planning to continue this global licensing strategy.
Veregen (previously Polyphenon E ointment) for the topical treatment of external genital warts is a concentrate of catechins with a complex defined composition, extracted from green tea leaves. MediGene acquired the basic rights to the active ingredient in Veregen from the Canadian company Epitome Pharmaceuticals, Ltd. in 1999, and was solely responsible for the drug’s successful preclinical and clinical development, as well as the approval process.
Patent protection has also been further upgraded by a number of proprietary inventions. Sinecatechins 15% ointment (Veregen) is now also recommended as a treatment option in the US Department of Health and Human Services’ Centre for Disease Control and Prevention's Sexually Transmitted Diseases Treatment Guidelines 2010 for the treatment of genital warts.
MediGene AG is a biotechnology company and the first German biotech company to have revenues from marketed products. It has several drug candidates in clinical development and possesses innovative platform technologies and focuses on clinical research and development of novel drugs, with a focus on oncology.