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2004 DEC 2 - (NewsRx.com & NewsRx.net) -- Antares Pharma, Inc., (AMEX:AIS) said that new phase II data on LibiGel, a gel formulation of testosterone, being developed by BioSante Pharmaceuticals, Inc., (AMEX:BPA) highlighted key advantages of Antares Pharma's Advanced Transdermal Delivery (ATD) gel technology when compared with a transdermal testosterone patch delivery system.
Phase II data on LibiGel, as reported by Antares Pharma's licensee, BioSante, indicated minimal application site irritation in contrast to previous trials with a transdermal testosterone patch delivery system in which approximately 30% of subjects reported such reactions. Additionally, LibiGel produced testosterone blood levels within the normal range for premenopausal women and had a safety profile similar to that observed in the placebo group with no serious adverse effects observed.
"Antares Pharma believes its proprietary ATD gel technology offers compelling advantages compared with transdermal patches, such as Intrinsa, and that these advantages include not only the lack of irritation associated with occlusion and response to adhesives but also cost, efficiency of delivery and cosmetic elegance," according to Antares Pharma's president and CEO, Jack E. Stover. Stover also added, "We believe that the data emerging from clinical trials of LibiGel, while still early, confirm our expectations that LibiGel will compare favorably on all important dimensions."
BioSante recently announced new phase II clinical data on LibiGel that was presented before the International Society for the Study of Women's Sexual Health (ISSWSH) Annual Meeting.
Pursuant to its agreement with BioSante, Antares Pharma expects to receive milestone payments from BioSante at certain stages of development and royalties from end sales of LibiGel in North America. Importantly, ...