Tokyo, Japan – 13 August 2007: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), the biopharmaceutical company, today announced the completion of a Japanese 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 HRA Pharma.
The clinical study was a randomised, 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 subjects in three cohorts were enrolled at a single study centre. The trial achieved all of its primary and secondary endpoints. 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 approved in 65 countries and is both well-tolerated and effective as an oral emergency contraceptive for post-coital use.
“We are delighted to complete our Phase I study of SOH-075, which is the only ECP under development in Japan. We will do our best to provide this product, which is widely used elsewhere in the world, to women in Japan” said Mr Shinichi Tamura, Chief Executive Officer of Sosei.
André Ulmann, CEO of HRA Pharma added: "This Phase I result provides further validation of NorLevo® as an ECP. We are delighted to see our product progress further towards commercialisation in Japan."