TOKYO, Nov. 16 /PRNewswire-FirstCall/ -- Sosei Group Corporation , the biopharmaceutical company, today announced the initiation of a Phase I clinical trial for the emergency contraceptive pill (ECP) SOH-075 (NorLevo(R)). 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(R) is an oral emergency contraceptive “morning after pill” which is used to prevent pregnancy after unprotected intercourse. NorLevo(R) 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(R) 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(R) 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.
Enquiries Sosei Group Corporation Ichiban-cho FS Bldg., 8 Ichiban-cho, Chiyoda-ku, Tokyo 102-0082 Japan Hiroki MAEKAWA, Representative Executive Officer, E-mail: hmaekawa@sosei.com Tel: +81-3-5210-3399 Fax: +81-3-5210-3291 Sosei Inc. 630 Fifth Avenue, Suite 2005, New York, NY 10111 John DAFFURN, President, Sosei Inc. E-mail: daffurnj@sosei.com Tel: +1 212 332 5003 Fax: +1 212 332 3401 Financial Dynamics Tel: + 44 (0)207 831 3113 Julia Phillips The Trout Group Tel: +1 212 477 9007 Brandon Lewis (extension 15) Thomas Fechtner (extension 31) Editor’s notes: levonorgestrel
ECP is necessary for women who have the suspicion of an unwanted pregnancy caused by unprotected intercourse. As a result of a large multinational study in 1998, the World Health Organization (WHO) demonstrated that levonorgestrel mono therapy, such as NorLevo(R), was well-tolerated and more effective than the Yuzpe method (ethinyl estradiol and levonorgestrel), a traditional emergency contraception method used since 1977. Levonorgestrel mono therapy for emergency contraception is listed as an essential drug by the WHO.
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
About HRA Pharma
HRA Pharma is a private pharmaceutical company that creates and markets innovative medicines and products for women’s and reproductive health, hormonal cancer treatments and cell-based therapies.
Its first product, NorLevo(R) emergency contraception, was launched in France in 1999 and is marketed in over 50 countries. The company has four other marketed products and a strong R&D pipeline. Its products are marketed through global marketing partners and through its own sales organisation in France and parts of Europe.
For further information please visit the website at http://www.hra-pharma.com
Sosei Co., Ltd.
CONTACT: Hiroki Maekawa, Representative Executive Officer,+81-3-5210-3399, Fax - +81-3-5210-3291, hmaekawa@sosei.com; or JohnDaffurn, President, Sosei Inc., +1-212-332-5003, Fax - +1-212-332-3401,daffurnj@sosei.com; or Julia Phillips, Financial Dynamics,+44-(0)207-831-3113; or The Trout Group, +1-212-477-9007, Brandon Lewis,ext. 15, or Thomas Fechtner, ext. 31
