German-American biotech company MediGene has had its application to market a treatment for genital warts accepted by the US Food and Drug Administration (FDA), kicking off the review process for the product.
Polyphenon E is an ointment based on green tea extract rich in catechins which has been shown in Phase III trials to be effective in clearing genital warts, which are notoriously difficult to treat. Genital warts are benign but disfiguring, and are one of the fastest spreading sexually-transmitted disorders 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.
MediGene said it expects Polyphenon E to achieve sales of around 100 million euros a year for genital wart treatment, and is in advanced negotiations with a partner for the product. It plans to submit the product for aproval in Europe in 2006.