BioSante licenses contraceptive technology from Wake Forest University

BioSante Pharmaceuticals in the US has exercised an option for a licence from Wake Forest University Health Sciences and Cedars Sinai Medical Center to three patents encompassing triple hormone contraception technology - a novel combination of estrogens and progestins with androgens, such as testosterone.

The licence, which covers all potential routes of administration, follows BioSante's existing licence to triple hormone therapy for menopausal women.

Data indicate that a woman's testosterone levels can decrease by around 30% to 50% between her 20s and 40s. This natural decrease, combined with a decrease in testosterone levels due to oral contraceptive use, may result in lower sexual desire and activity in some women. The testosterone component of the triple hormone contraceptive formulation may help restore sexual desire and activity to women taking traditional oral contraceptives who have experienced this side effect.

Stephen Simes, president and ceo of BioSante said: 'Our plan is to study LibiGel, our transdermal testosterone gel for female sexual dysfunction, as the androgen component of this technology, and ultimately combine these hormones in a single product that would aid therapy, compliance and cost. Currently, approximately 10m women in the US use oral contraceptives.'

The financial terms of the exclusive, worldwide licence include an upfront payment by BioSante and regulatory milestone payments, maintenance payments and royalty payments if a product incorporating the licenced technology is approved and subsequently marketed.

BioSante is preparing a New Drug Application for submission to the US FDA for Bio-E-Gel (bioidentical estradiol gel) for reducing hot flashes. It also plans to initiate Phase III testing of LibiGel (bioidentical testosterone gel) for the treatment of female sexual dysfunction in menopausal women by the end of 2005.