TOKYO, September 30 /PRNewswire-FirstCall/ -- Sosei Group Corporation , the biopharmaceutical company, today announced the submission of the New Drug Application (NDA) for the emergency contraceptive pill SOH-075 (NorLevo(R)) to Ministry of Health, Labour and Welfare (MHLW) by Sosei Co. Ltd., its wholly owned Japanese subsidiary.
NorLevo(R) is an oral emergency contraceptive "morning after pill" which is used to prevent unwanted pregnancy after unprotected intercourse. NorLevo(R) 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.
Editor's Notes:
About Sosei
Sosei Group is a leading international biopharmaceutical company with significant expertise in product discovery and development. It has established a reduced risk business model primarily upon identifying new uses for established drugs and exploiting its unique position within Japanese, European and North American pharmaceutical markets by acquiring compounds from, and bringing compounds into, Japan.
For further information about Sosei, please visit http://www.sosei.com
SOURCE Sosei Group Corporation
CONTACT: Enquiries: Sosei Group Corporation, Tsuruya Hachiman Bldg. 5F,
Kojimachi 2-4, Chiyoda-ku, Tokyo 102-0083 Japan, Hidetoshi Torami,
Executive Officer, E-mail: htorami@sosei.com, Tel: +81-3-5210-3399, Fax:
+81-3-5210-3291
