Sosei Announces Completion of Phase III Trial for NorLevo(R)
The clinical study was designed to evaluate the safety and preventedpregnancy rate of SOH-075 in Japanese adult female subjects who requireemergency contraception. No serious adverse events were reported during thestudy.
Further announcement will be made when all study results are fullyanalysed.
NorLevo(R) is an oral emergency contraceptive "morning after pill" whichis used to prevent pregnancy after unprotected intercourse. NorLevo(R)contains only levonorgestrel as an active ingredient. The dosing is startedwithin 72 hours after unprotected sexual intercourse. NorLevo(R) was firstlaunched in Europe in 1999 and is currently approved in some 60 countries,the product being both well-tolerated and effective as an oral emergencycontraceptive for post-coital use.
"We are delighted to announce the completion of Phase III trial ofSOH-075, which will be the first ECP to be introduced into Japan. We believethat this product will meet one of the needs of Japanese women and that thetrial will confirm that NorLevo(R) is as safe and effective in thispopulation as has already been demonstrated in other countries," said MrShinichi Tamura, Chief Executive Officer of Sosei.
Andre Ulmann, CEO of HRA Pharma added: "We're very proud of reaching thisimportant milestone in Japan. We hope that, access to emergency contraceptionwill benefit Japanese women and families by improving reproductive health."
ECP is necessary for women who may be concerned about the possibility ofan unwanted pregnancy following unprotected intercourse. Two largemultinational studies, aiming to test a 12-24h regimen (Lancet, 1999) and asingle administration (Lancet, 2002), both performed by the World HealthOrganisation (WHO) demonstrated that levonorgestrel mono therapy, such asNorLevo(R), was well-tolerated and more effective than the Yuzpe method(ethinyl estradiol and levonorgestrel), a traditional emergency contraceptionmethod used since 1977. Levonorgestrel mono therapy for emergencycontraception is listed as an essential drug by the WHO.
Sosei Group is a leading international biopharmaceutical company withsignificant expertise in product discovery and development. It hasestablished a reduced risk business model primarily upon identifying new usesfor established drugs and exploiting its unique position within Japanese,European and North American pharmaceutical markets by acquiring compoundsfrom, and bringing compounds into, Japan.
For further information about Sosei, please visit http://www.sosei.com
About HRA Pharma
HRA Pharma creates innovative medicines and products for women's andreproductive health, endocrine diseases, and cell-based therapies. TheCompany discovers, develops and markets its own products and licenses-inthird party products as well. The company markets its products in more than50 countries either through its own sales force or through a network ofdistributors and licensees.
For further information please visit the website athttp://www.hra-pharma.com
SOURCE Sosei Group Corporation
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