Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), the biopharmaceutical company, today announced that Sosei Co., Ltd., its wholly owned Japanese subsidiary, was granted approval for its emergency contraceptive pill, NorLevo(R) TABLETS 0.75mg, by the Japan Ministry of Health, Labour and Welfare (MHLW). NorLevo(R) has thus become the fist emergency contraceptive pill available in Japan.
NorLevo(R) is an oral emergency contraceptive, which is taken within 72 hours after unprotected sexual intercourse or contraceptive failure to prevent unwanted pregnancy. Its active ingredient, levonorgestrel, is listed as an essential drug by WHO.
Sosei acquired the exclusive distribution rights to the product in Japan and Australia from Laboratoire HRA Pharma in April 2001. NorLevo(R) was first launched in Europe in 1999 and is currently approved in some 50 countries.
According to the distribution agreement, which Sosei signed with ASKA Pharmaceutical Co., Ltd. in November 2009, ASKA will be responsible for commercialization of NorLevo(R) in Japan and is expected to launch the product in the middle of May 2011.