BioSante gets $7M milestone as FDA OKs Elestrin

Drug developer BioSante Pharmaceuticals says it is entitled to a $7.0 million payment from fellow US firm Bradley Pharmaceuticals, as a result of the Food and Drug Administration's approval of Elestrin (estradiol gel) for the treatment of moderate-to-severe hot flashes. BioSante added that it could receive up to $40.0 million from the accord, but noted that this would yield $30.0 million after payments it must make to its technology licensor, Antares Pharma.

Lincolnshire, Illinois-headquartered BioSante said that the FDA has approved two daily dosages of the drug (12.5mg and 37.5mg), with the former being the lowest dose estradiol-based product to be cleared in the USA.

The $7.0 million, which is stipulated under Bradley's in-licensing of the drug earlier this year (Marketletter January 1 & 8), will be provided in two seperate sums, the second of which will be transferred in December. Bradley is expected to launch the agent in mid-2007, and will support the product with a sales force of at least 50 representatives.