BIOSANTE WINS APPROVAL FOR ESTRADIOL GEL PRODUCT

BioSante Pharmaceuticals announced that it received FDA approval for the marketing of Bio-E-Gel. Bio-E-Gel (estradiol gel), which will be marketed under the name Elestrin, is indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause. Two doses of Elestrin, 0.87 grams per day and 1.7 grams per day, were approved. Elestrin 0.87 grams per day is the lowest dose of estradiol approved by the FDA for the treatment of moderate-to-severe vasomotor symptoms.

BioSante announced the signing of a marketing agreement with Bradley Pharmaceuticals on Nov. 8. Bradley plans to market Elestrin in the U.S. in 2007 through its Kenwood Therapeutics Division. 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.

Elestrin is a fast-drying gel formulation of bio-identical estradiol, the same estrogen produced naturally in women. Elestrin 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. Elestrin is administered using a metered dose applicator that delivers 0.87 grams 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 conducted to identify the lowest effective dose to allow estrogen treatment in the safest possible manner. Study results showed a clear dose response in the reduction in the number and severity of hot flashes in the doses tested. The lowest dose of Elestrin studied produces very low estradiol blood levels and exhibits a safety profile similar to that observed in the placebo group. There were no significant differences in the safety profile of any dose of Elestrin compared with placebo other than predictable estrogen effects, such as breast tenderness.