Polyphenon® E for the treatment of HPV infections
In 1997 Epitome Pharmaceuticals Ltd. licensed from Mitsui Norin Company (Japan), a patented method of treating external genital warts through the topical application of Polyphenon® E green tea extract.
In 1999 this technology was sublicensed to MediGene AG, a publicly traded German biotech company. MediGene and Epitome collaborated on a multi-centre Phase II trial. In 2003 MediGene extended its licence to include the treatment of hyperplasia caused by papilloma viruses.
In 2004 MediGene conducted two Phase III trials, one in Europe and another in the Americas. Based on these trial results, MediGene submitted the New Drug Application to the FDA in September 2005. In October 2006 the US FDA approved Veregen®. The NDA submission to European authorities was accepted in April 2007. MediGene predicts sales for this product in US and European markets to peak at €130 million per year.
Veregen® is a registered trademark of MediGene AG.
Polyphenon® is a registered trademark of Mitsui Norin Co., Ltd.
Early Drug Development in cooperation
with the Pharmaceutical Industry