Bradley, MediGene sign deal to commercialize genital wart cream Polyphenon E in United States

By E. Janene Geiss

Philadelphia, Jan. 31 - Bradley Pharmaceuticals, Inc. said Tuesday that the company has entered into a collaboration and license agreement with MediGene AG to commercialize Polyphenon E ointment in the United States through Bradley's specialty sales and marketing teams.

The Food and Drug Administration recently accepted for filing MediGene's New Drug Application for Polyphenon E, according to a company news release.

The active ingredient in the ointment is a defined mixture of catechins extracted from green tea patented for use as a pharmaceutical product for the treatment of hyperplasias caused by papilloma viruses such as external genital and perianal warts, officials said.

Genital warts appear as benign but contagious skin tumors in the genital and anal areas. This disease is one of the most common and fastest spreading venereal diseases worldwide. It is estimated that about 14 million people in the United States are infected with the strains of human papilloma virus that cause genital warts, making the United States the largest market for this indication, officials said.

Bradley and MediGene said they will together decide whether to develop Polyphenon E for other dermatological indications based on a joint clinical development plan.

"This agreement marks Bradley's expansion into new specialty health care markets and is an important milestone for the company. Management feels strongly that this endeavor will bring the individual strengths of both Bradley and MediGene together and will result in a synergistic relationship that fuels the growth of both companies," Daniel Glassman, Bradley president and chief executive officer, said in the release.

Bradley is a Fairfield, N.J., specialty pharmaceutical company and markets to niche physician specialties in the United States and 38 international markets. Bradley acquires non-strategic brands, enhances brands with line extensions and improved formulations and grows the products through promotion, advertising and selling activities to optimize life cycle management. Bradley is comprised of Doak Dermatologics, specializing in topical therapies for dermatology and podiatry, and Kenwood Therapeutics, providing gastroenterology, respiratory and other internal medicine brands.

MediGene, based in Munich, Germany, and San Diego, is a biotechnology company focused on research and development of novel approaches for the treatment of cancer.

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