Under the terms of the agreement, Sosei will be responsible for development and registration and Aska for sales and marketing. A joint committee will be established to oversee all the commercialization activities. As part of the deal structure, Sosei will receive upfront and milestone payments as well as a significant portion of net sales. Aska will also acquire shares of Sosei.
NorLevo (SOH-075) is an oral emergency contraceptive ‘morning after pill’ which is used to prevent unwanted pregnancy after unprotected intercourse. NorLevo contains only levonorgestrel as an active ingredient. The dosing is started within 72 hours after unprotected sexual intercourse.
Sosei acquired the exclusive distribution rights to the product in Japan from HRA Pharma. The Phase III study was completed in October 2008, and filing of the new drug application in Japan is planned for the first half of 2009.