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Bradley Pharmaceuticals Announces Polyphenon E Ointment, 15% Approved by FDA

FAIRFIELD, N.J., October 31, 2006 -- Bradley Pharmaceuticals, Inc. announced today that the Company has been notified by MediGene AG that MediGene received FDA approval from the U.S. Food and Drug Administration (FDA) to market Polyphenon E Ointment, 15%, a new drug indicated for the treatment of external genital and perianal warts and patented through 2017. The product, developed by MediGene AG, will be commercialized in the United States by Bradley and is expected to launch during the second half of 2007. With FDA approval, MediGene is due a $14M milestone payment from Bradley.

Both Bradley operating units will market Polyphenon E Ointment, 15%, with the Doak Dermatologics subsidiary promoting Polyphenon E Ointment, 15% to dermatologists, and Bradley’s Kenwood Therapeutics division marketing this topical therapy to the OB/GYN specialty.

The active ingredient in Polyphenon E Ointment, 15% is a defined mixture of catechins extracted from green tea and proven effective for the treatment of external genital and perianal warts caused by certain strains of human papilloma virus (HPV). External genital warts are one of the most common and fastest spreading venereal diseases worldwide. It is estimated that approximately 14 million people in the United States are infected with the strains of HPV that cause external genital warts, making the U.S. the largest market for this indication. Current treatment for this condition primarily consists of cryosurgery and the topical therapy Aldara(TM) (imiquimod). Polyphenon E Ointment, 15% is the first new treatment for this condition since Aldara(TM) was introduced in 1997.

Bradley President and CEO Daniel Glassman stated, "The approval of Polyphenon E Ointment, 15% is very exciting news for Bradley. With its launch, Bradley will achieve another milestone in the execution of the Company’s strategic plan to increase shareholder value by broadening our product offerings through in-licensing long-term patent-protected therapies, and leveraging the promotional capabilities of Doak and Kenwood and their established physician relationships."

Aldara is a trademark of 3M.

Source: Bradley Pharmaceuticals, Inc.

Posted: October 2006


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