BioSante's Elestrina cleared in the USA

The USA's BioSante Pharmaceuticals has received Food and Drug Administration marketing approval for its Bio-E-Gel estradiol formulation in the USA. The agent, which will be marketed under the name Elestrina, is indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause.

Two doses of Elestrina, 0.87g per day and 1.7g per day, were approved. The firm noted that 0.87g is the lowest daily dose of estradiol approved by the FDA for the indication. In November 2006, BioSante signed a marketing agreement with USA-based Bradley Pharmaceuticals. Upon execution of the deal, BioSante received $2.6 million and now, the approval of Elestrina has triggered a $7.9 million payment, $5.2 million of which will be paid within 14 weeks and $2.6 million within a year. Bradley has also agreed to pay BioSante royalties as well as sales-based milestones. The total amount of up-front fees and milestones could total over $40.0 million which is net of BioSante's obligations to Antares Pharma, from which it licensed the transdermal estradiol formulation used in Elestrina.