The payment is the second of two triggered by the December 2006 FDA approval of Elestrin, a treatment for reducing hot flashes associated with menopause, and brings the total upfront and milestone payments received to $14 million. BioSante has the right under the agreement to receive up to an additional $40 million upon the achievement of certain sales-based milestones and has been receiving royalties since the mid-year launch of the product.
BioSante received approval from the FDA for the marketing of Elestrin in the US on December 15, 2006. The FDA approved two doses of Elestrin, 12.5 micrograms per day and 37.5 micrograms per day in a non-conditional full approval.
Stephen Simes, president and CEO of BioSante, said: “With about $30 million in cash, we actively are working on our LibiGel (transdermal testosterone gel) Phase III development program.”