MediGene Signs Agreement with Solvay for the Commercialization of Veregen in Germany, Austria, and Switzerland

30-Sep-2009 - Austria

MediGene AG has signed a license and supply agreement with Solvay Arzneimittel GmbH, the German affiliate of Solvay Pharmaceuticals (Solvay) for the supply and commercialization of Veregen® (formerly Polyphenon E® ointment) in Germany, Austria, and Switzerland. Solvay's subsidiaries will promote and distribute the drug for the treatment of genital warts in the above-mentioned countries. In Switzerland Solvay will also take charge of the Veregen® regulatory procedures. Upon the achievement of specified milestones and sales targets, MediGene is entitled to successive payments totalling up to 3.65 million euros. MediGene will supply Solvay with the finished product, and will receive royalties on net sales.

In July 2009, MediGene's marketing authorization application for Veregen® was assessed positively by the national regulatory authorities of Germany, Austria, and Spain in a decentralized approval procedure. The recent grant of formal marketing authorization in Germany was the first such authorisation implemented by a European national regulatory authority. Marketing authorization of Veregen® in Germany (the reference state in this decentralized process) will provide a basis for additional marketing authorization applications to be submitted in additional European countries. The issue of formal marketing authorizations in Austria and Spain is expected within the next few months. German market launch is planned for the first half of 2010, and MediGene intends to conclude additional marketing agreements in other countries both within and outside Europe.

https://www.bionity.com/en/news/107062/medigene-signs-agreement-with-solvay-for-the-commercialization-of-veregen-in-germany-austria-and-switzerland.html