Antares Pharma Inc announced the achievement of additional milestones in the development of its proprietary transdermal gel technology which simultaneously delivers estradiol and norethindrone acetate across the skin. This combination product is being developed for alleviation of vasomotor symptoms associated with menopause and has been licensed to Solvay Pharmaceuticals B.V. in Europe and BioSante Pharmaceuticals Inc in the United States. BioSante subsequently sub-licensed the product to Solvay Pharmaceuticals, Inc. in the United States.
The milestones represent continued stages in development of the product. Milestone payments were received from Solvay and BioSante following the satisfaction of product development goals. The BioSante milestone resulted from work to support registration of the product in the United States. Specific details of the milestone payments were not released.
Roger G. Harrison, President and CEO of Antares Pharma commented, "We are pleased with continued progress being made with this combination product. We continue to believe that transdermal gels offer significant advantages over other product forms that can be used for hormone therapy, particularly with regard to the simple and discreet topical application." In further comments Dr. Harrison indicated that other Antares Pharma topical gel hormone therapy formulations licensed to BioSante continue to make progress, including estradiol for treatment of menopausal women and testosterone for treatment of female sexual dysfunction. He further added, "It is becoming increasingly recognized that addressing testosterone deficiency in both men and women can positively impact quality of lives and represents a largely unmet medical need. Gel products are easy to apply, offer ease of dose titration, and can avoid the fluctuations in plasma levels seen with oral dosage forms."