Tokyo, Japan – 17 November 2006: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), the biopharmaceutical company, today announced the initiation of a Phase I clinical trial for the emergency contraceptive pill (ECP) SOH-075 (NorLevo®). Sosei acquired the exclusive distribution rights to the product in Japan from Laboratoire HRA Pharma which is currently approved and marketed in over 50 countries.
The clinical study is a randomized, double blind, placebo-controlled trial designed to evaluate the safety and pharmacokinetics of SOH-075 in healthy Japanese adult female volunteers. A total of 33 volunteers in three cohorts will be enrolled at a single study center.
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. Since it inhibits pregnancy before the implantation of the egg, it is not a controversial pregnancy termination pill, but a helpful opportunity for post-coital contraception. NorLevo® has been successfully marketed in many countries and is both well-tolerated and effective as an oral emergency contraceptive for post-coital use.
“We are delighted to be able to commence our first trial of this product, 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 has the same excellent pharmacokinetic profile in this population as has already been demonstrated in other countries” said Mr Shinichi Tamura, Chief Executive Officer of Sosei.