Tokyo, Japan – 20 February 2008: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), the biopharmaceutical company, today announced the initiation of a Japanese Phase III clinical trial for the emergency contraceptive pill (ECP) SOH-075 (NorLevo®). Sosei acquired the exclusive distribution rights to the product in Japan from HRA Pharma.
The clinical study is designed to evaluate the safety and prevented pregnancy rate of SOH-075 in Japanese adult female subjects who require emergency contraception. 1.5mg of the drug will be administered once within 72 hours after sexual intercourse. NorLevo® is an oral emergency contraceptive “morning after pill” which is used to prevent pregnancy after unprotected intercourse. NorLevo® contains only levonorgestrel as an active ingredient. The dosing is started within 72 hours after unprotected sexual intercourse. NorLevo® was first launched in Europe in 1999 and is currently approved in some 65 countries, the product being both well-tolerated and effective as an oral emergency contraceptive for post-coital use.
“We are delighted to be able to commence Phase III trial of SOH-075, which will be the first ECP to be introduced into Japan. We believe that this product will meet one of the needs of Japanese women and that the trial will confirm that NorLevo® is as safe and effective in this population as has already been demonstrated in other countries” said Mr Shinichi Tamura, Chief Executive Officer of Sosei.
André Ulmann, CEO of HRA Pharma added: "The initiation of phase III clinical trial of Norlevo® in Japan constitutes a major step in the development of the product for the benefit of Japanese women. We are very pleased that NorLevo® is well on its way to becoming available in Japan."