BioSante Pharmaceuticals, Inc has reacquired Elestrin (estradiol gel) from Nycomed US who in February 2008 acquired Bradley Pharmaceuticals, Inc, BioSante's previous licensee of Elestrin. BioSante immediately will assume all manufacturing, distribution and marketing responsibilities for Elestrin. Elestrin is a fast-drying gel formulation of estradiol, the same estrogen produced naturally in women, and is US Food and Drug Administration (FDA) approved for the treatment of hot flashes in menopausal women.
"We are pleased to reacquire Elestrin since Nycomed concentrates on dermatology products and neither Bradley nor Nycomed to date were successful in marketing Elestrin," said Stephen M Simes, BioSante's president & CEO. "BioSante will pursue the best course of action to maximize the value of Elestrin. These considerations will become part of our formal strategic review being led by Deutsche Bank Securities Inc, whom we recently engaged as our strategic advisor to assist us in our ongoing process to explore strategic alternatives in order to maximize value to our stockholders."
In addition to Elestrin, which BioSante developed through FDA approval in 2006, BioSante actively is developing LibiGelÆ (testosterone gel) for the treatment of female sexual dysfunction (FSD) in menopausal women, specifically hypoactive sexual desire disorder (HSDD). At present in the US there is no FDA approved pharmaceutical product for either FSD or HSDD, a market estimated to be approximately $2.0-$4.0 billion in size. BioSante believes LibiGel, if approved by the FDA, may be the first pharmaceutical product approved in the US for the treatment of HSDD in menopausal women.
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 percent lower than the lowest dose transdermal estradiol patch that is FDA approved for the treatment of hot flashes in the US.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism.