BioWorld International Correspondent
MUNICH, Germany - MediGene AG completed its second Phase III trial of Polyphenon E, a treatment for genital warts, getting significant clinical effects compared to placebo, as well as good tolerability.
The trial involved 500 patients and the data surpassed positive results from a European Phase III trial that was completed in March.
Based on the trials, MediGene, of Martinsried, plans to submit a new drug application in the U.S. by mid-2005. If approved, Polyphenon E would be MediGene's second product, following Eligard, approved in May as a treatment for advanced prostate cancer.
"We will focus on the American market first," said Julia Hofmann, spokeswoman for the company. "We will file for approval about six months later in Europe."
MediGene holds all rights for the compound, and the company undertook the Phase III trials with its own resources. "We are planning partnerships for sales and marketing," Hofmann said. "At present, we are talking with potential partners, and we hope to close a deal next year."
The company said genital warts are one of the most common and fastest-spreading venereal diseases worldwide. The warts are benign, but contagious and difficult to treat. They are caused by human papillomavirus (HPV Type 6 or 11). MediGene estimates Polyphenon's peak sales in that indication at about $130 million annually.
The compound also is in Phase II trials in actinic keratosis, a precursor of skin cancer. The company estimates peak annual sales in the second indication at about $260 million.
MediGene pursued genital warts as the first indication because it was clear they are caused by HPV.
"We licensed the compound after a Phase I study in genital warts, so it made sense to continue the clinical development in that indication until we could show efficacy," Hofmann said. "It was not immediately clear that keratosis could also be triggered by the virus."
She said that the keratosis trial began in April and could be completed by the middle of 2005.
"It's too early to say whether we will also do a Phase III trial for keratosis with our own resources," Hofmann said, adding that that would "depend on our partnership negotiations."
The second Phase III trial for genital warts was carried out in a total of 50 clinical centers in North and South America and Romania. The ointment was applied to the affected areas three times a day over a maximum period of 16 weeks. The trial resulted in complete clearance of the warts that existed at the beginning of the trial, as well as new ones that appeared during the trial, in about 57 percent of patients treated with a Polyphenon E 15 percent ointment. In about 78 percent of the patients in that group, either a majority or all of the warts disappeared by the last visit. Recurrence during 12 weeks of follow-up was seen in less than 7 percent of those patients.