Tokyo, Japan – 30 September 2009: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), the biopharmaceutical company, today announces the submission of the New Drug Application (NDA) for the emergency contraceptive pill SOH-075 (NorLevo®) to Ministry of Health, Labour and Welfare (MHLW) by Sosei Co. Ltd., its wholly owned Japanese subsidiary.
NorLevo® 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 has acquired the exclusive distribution rights to the product in Japan from HRA Pharma. The NDA is supported by the data from Phase III study that was successfully completed in October 2008.