Elestrin is indicated in the US for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause. PharmaSwiss is responsible for regulatory and marketing activities in Israel. Financial terms of the agreement were not disclosed.
PharmaSwiss will submit BioSante’s approved US new drug application to the Israeli authorities based on BioSante results and manufacturing information. Approval in Israel is expected to take approximately one year.
Elestrin is a fast-drying gel formulation of estradiol, the same estrogen produced naturally in women. Elestrin is absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a non-irritating, painless manner, BioSante said.
Stephen Simes, president and CEO of BioSante, said: We are happy to sign this agreement with PharmaSwiss. We believe PharmaSwiss is in an excellent position to capture an important share of the Israeli estrogen therapy market once Elestrin is approved in Israel. We look forward to working with PharmaSwiss on the regulatory approval and on the successful marketing of Elestrin in Israel.