Approval paves the way for decentralized regulatory process in other European countries.
The German regulatory authorities approved MediGene’s topical genital warts treatment, Veregen®. Approval follows July’s positive assessment by the German, Austrian, and Spanish national regulatory bodies.
German market approval is the first for Veregen in Europe, and the country will act as the reference member state for the decentralized process through which marketing authorization applications can be submitted for other European countries. MediGene says that the Austrian and Spanish authorities are expected to issue formal clearance within the next few months.
Veregen has been available in the U.S. since December 2007 and has been distributed by the company’s licensee, Nycomed, since early 2009. The company similarly plans to distribute Veregen in Europe via partners. “I am confident that we will be able to conclude a marketing partnership for Germany within the next few weeks,” says Frank Mathias, Ph.D., MediGene’s CEO. In June MediGene signed a deal with Spanish company Juste SAQF for distribution of Veregen in Spain and Portugal.