Agreement includes Germany, where approval has been granted, as well as Austria and Switzerland.
Solvay’s German affiliate, Solvay Arzneimittel, negotiated a license and supply agreement with MediGene for the latter’s topical genital warts treatment, Veregen®, in Germany, Austria, and Switzerland. MediGene will provide Solvay with the finished product and could receive milestones and sales-related payments of up to €3.65 million (about $5.31 million) plus royalties on net sales.
German marketing authorization for Veregen® was granted on September 9 and represents the first for the drug in Europe. MediGene says that Germany will now represent the reference member state for the EU’s decentralized regulatory process and will provide the basis for additional marketing authorization applications to be submitted in other European countries.
Regulatory submission has also been assessed positively by the Austrian and Spanish national authorities. Formal marketing authorizations in Austria and Spain are expected within the next few months, the company adds.
Veregen has been available in the U.S. for the treatment of external genital warts since December 2007. It is now marketed in the U.S. by Nycomed, which took over MediGene’s original sales partner Bradley Pharmaceuticals at the end of 2007.