BPA Biosante Pharmaceuticals

BioSante Pharmaceuticals, Inc. (Amex:BPA) today announced that it has signed an exclusive agreement with Bradley Pharmaceuticals, Inc. (NYSE:BDY) for the marketing of Bio-E-Gel� (transdermal estradiol gel) in the United States. Upon execution of the agreement, BioSante received $2.625 million. Additional regulatory and sales based milestone payments could bring the total of such payments from Bradley to BioSante to more than $40 million. In addition, Bradley has agreed to pay to BioSante royalties on sales of Bio-E-Gel, if and when Bio-E-Gel is approved by the U.S. Food and Drug Administration (FDA) and marketed by Bradley. Bio-E-Gel is currently being reviewed by the FDA. BioSante submitted the Bio-E-Gel new drug application (NDA) in February 2006. Bradley, through its Kenwood Therapeutics division, has agreed to market Bio-E-Gel and target estrogen prescribing physicians in the U.S. comprised mostly of gynecologists with at least 49 Kenwood sales representatives. The total amount of the up-front and milestone payments mentioned above is net of BioSante�s obligations to Antares Pharma, BioSante�s licensor of the transdermal estradiol gel formulation in Bio-E-Gel. �We are excited to have met another milestone toward our planned commercial launch of Bio-E-Gel,� said Stephen M. Simes, president & CEO of BioSante. �We believe Bradley is an excellent mid-sized specialty pharmaceutical company to market Bio-E-Gel and that Bradley is in an excellent position to capture a share of the U.S. estrogen therapy market, which is currently estimated at approximately $1.3 billion in annual sales, of which the transdermal segment, mostly patches, is about $250 million. We look forward to working with Bradley toward a successful launch of Bio-E-Gel in 2007.� Dan Glassman, president & CEO of Bradley said, �We are impressed with the clinical results of the Bio-E-Gel development program and we believe Bio-E-Gel and its low dose regimen will be an attractive alternative for physicians who treat and for women who suffer from menopausal symptoms.� About Bio-E-Gel� Bio-E-Gel is a fast-drying gel formulation of estradiol, the same estrogen produced naturally in women. Bio-E-Gel was developed to be absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a non-irritating, painless manner. Bio-E-Gel is administered using a metered dose applicator that delivers 0.87 g of gel per actuation, thereby allowing for precise titration from dose to dose. The gel dries quickly in one to two minutes. A 12-week, double-blind, placebo-controlled Phase III study of 484 symptomatic menopausal women was designed to identify the lowest effective dose to allow estrogen treatment in the safest possible manner. The lead investigator for the multicenter study was Dr. James A. Simon, director of the Women's Health Research Center in Washington, D.C. The women in the study were randomly assigned to one of four treatment arms: low-dose (0.87 g), mid-dose (1.7 g) or high-dose (2.6 g) of Bio-E-Gel, or matching placebo. The U.S. Food & Drug Administration (FDA) defined endpoints were a significant decrease over placebo in both the number and severity of hot flashes at week 4 and week 12 of treatment. Study results showed a clear dose response in the reduction in the number and severity of hot flashes in the low, mid, and high doses tested. The most effective Bio-E-Gel dose decreased the number of hot flashes by 85 percent by 12 weeks of treatment, from 12.9 hot flashes per day at baseline to 1.6 per day at the end of the 3 month study. The decrease compared to placebo treatment was significant (p