German biotech MediGene has been given a green light in the US to market its Polyphenon E Ointment for the treatment of genital warts.
Medigene said that the Polyphenon E would be launched in the USA by marketing partner Bradley Pharmaceuticals during the second half of 2007. The new product will be its second marketed drug, joining Eligard (leuprolide) for prostate cancer which is sold by licensee Astellas in the European Union.
It added that it would file for approval of Polyphenon E Ointment, whose active substance is an extract of green tea and can be used to treat both external and perianal genital warts, in Europe before the end of 2006.
MediGene stands to receive a milestone payment of $14 million from Bradley upon approval of the drug, and that it expected the drug to have an annual peak sales potential of $100 million in the USA.
External genital warts are one of the most common and fastest spreading sexually transmitted diseases worldwide, Approximately 14 million people in North America and 15 million people in Europe are infected by human papilloma viruses (HPV types 6 or 11), which cause genital warts, said the company.