MediGene AG has submitted an NDA for its Polyphenon E Ointment for the treatment of genital warts to the US FDA. MediGene owns the worldwide marketing rights for the drug and is planning submission for marketing authorization in Europe next year.
"Reaching this stage for our second drug represents a major success for MediGene. This again illustrates our expertise in bringing drugs from the early stages to the market,” Dr. Peter Heinrich, CEO of MediGene AG said adding, “We are planning for the US market launch of Polyphenon E Ointment in 2007 along with a marketing and commercialization partner followed by commercialization in Europe."
The active substance in Polyphenon E Ointment is a concentrate of catechines with a defined composition, extracted from green tea leaves. MediGene is developing this drug for the treatment of various skin tumours. For the indication genital warts, MediGene estimates the sales potential of this drug at more than 100 million EUR annually.
Genital warts are one of the most common and fastest spreading venereal diseases worldwide. Genital warts are benign, but disfiguring and contagious skin tumours in the genital and anal area, which are mostly difficult to treat. Approximately 14 million people in North America and 15 million people in Europe are infected by human papilloma viruses (HPV type 6 or 11), which cause genital warts.