Elestrin, approved for vasomotor symptoms associated with menopause, will be launched in 2009.

BioSante Pharmaceuticals granted Azur Pharma U.S. rights to Elestrin™, its menopause-related therapy for $3.3 million. The medication, which was approved in December 2006, will be launched in early 2009 and is patented through June 2022.

The upfront payment comprises a product licensing fee and payment for the transfer of the trademark and inventories, among other items. In addition, Azur Pharma will pay BioSante royalties and contingent milestones based on net sales of Elestrin.

Elestrin is a fast-drying gel formulation of estradiol, which is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Azur will market Elestrin to estrogen-prescribing physicians in the U.S. through its women’s health and urology sales force.

“We are impressed with the potential for Elestrin in the United States given its approved ultralow dose regimen,” says Seamus Mulligan, chairman and CEO of Azur.

“Azur is in an excellent position to capture an important share of the U.S. estrogen therapy market, which is currently estimated at approximately $1.4 billion in annual sales, of which the transdermal segment, mostly patches, is about $260 million,” points out Stephen M. Simes, president and CEO of BioSante. 

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