Last week, BioSante Pharma (BPAX) announced that it had reacquired Elestrin (estradiol gel) from privately-held Nycomed, which acquired the rights to the product along with its acquisition of Bradley Pharma in February 2008. BioSante will assume all manufacturing, distribution, and marketing responsibilities for Elestrin, which is a fast-drying gel formulation of estradiol (the natural form of estrogen in women) and FDA approved for the treatment of hot flashes in menopausal women. Elestrin will now be added to the formal strategic review being conducted by Deutsche Bank to maximize shareholder value. Also, insiders at BioSante accumulated over 147,000 shares ($2.15 per share) through the exercise of options at the end of July, continuing a consistent trend of insider buying on both the open market and via options.

Elestrin is 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 12.5 micrograms of estradiol, a dose that is 67% lower than the lowest dose transdermal estradiol patch that is FDA approved for the treatment of hot flashes in the US. 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. The total, single-entity US estrogen therapy market is estimated at about $1.4 billion in annual sales, of which the transdermal segment, mostly patches, is about $260 million. The low-dose efficacy of Elestrin is important because of consensus medical guidelines which recommend that women use the lowest effective dose of estradiol for the shortest period of time.

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