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news.The FDA has accepted for review MediGene's new drug application for its genital warts treatment, Polyphenon E ointment.
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This acceptance, which caused the company’s shares to jump by almost 10%, confirms that the application was sufficiently complete to allow a substantive review by the FDA.
The application is based on two phase III clinical trials conducted in Europe and the Americas enrolling more than 1,000 patients. The German-American biotech company said that it plans to submit a marketing authorization application in Europe in 2006.
“Pending approval, we plan to begin marketing Polyphenon E ointment in the US which currently represents the largest market for the target indication,” said Peter Heinrich, CEO of MediGene.
According to the company, 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 causes the genital warts.
The active substance in Polyphenon E ointment is a green tea extract with a defined catechin composition. MediGene is also developing the drug for the treatment of various skin tumors.