Our Medicines - JAPAN

NorLevo® 0.75mg
(Japan – launched 2011)

Indication:  Emergency contraception
Partner:  ASKA Pharmaceutical Co

An oral emergency contraceptive, which is taken within 72 hours after unprotected sexual intercourse or contraceptive failure to prevent unwanted pregnancy.

Its active ingredient, levonorgestrel (synthetic progestogen), is listed as an essential drug by WHO.

In 2001, we obtained exclusive distribution rights for Japan and Australia from HRA Pharma (France), implemented Phase 1 and Phase 2 clinical trials in Japan and validated the safety and efficacy of NorLevo®. In February 2011, we obtained the manufacturing and marketing approval by the MHLW and launched NorLevo® in May 2011. 

The Japan approved marketing authorization (MA) for NorLevo® was subsequently transferred from us to ASKA Pharmaceutical Co. Ltd in January 2014. Under the terms of the agreement, we will continue to receive a part of NorLevo® revenue until 2020.

For further details, please refer to HRA Pharma (France)

+ Press Releases 
-
28 Jan 2014: Sosei announces the transfer of Japan marketing authorization for NorLevo TABLETS 0.75mg to ASKA Pharmaceuticals
- 23 May 2011: Sosei to Launch NorLevo TABLETS 0.75mg (Emergency Contraceptive Pill) in Japan
- 22 Oct 2008: Sosei Agrees Terms with ASKA for Commercialisation of SOH-075(NorLevo)
- 10 Jul 2008: Sosei Announces Completion of Phase III Trial for NorLevo
- 20 Feb 2008: Sosei Announces Initiation of Phase III Trial for NorLevo
- 13 Aug 2007: Sosei Announces Completion of Phase I Trial for NorLevo
- 17 Nov 2006: Sosei Announces Initiation of Phase I Trial for NorLevo
- 19 Dec 2005: Sosei Sub-licenses NorLevo to Hexal for Australia


ORAVI®
(Japan - launching February 2019)

Indication:  Oropharyngeal candidiasis
Partner:  FUJIFILM Toyama Chemical Co., Ltd.

ORAVI® is a novel formulation of the Japanese pharmacopeia miconazole (antifungal agent), the once-daily treatment (50mg mucoadhesive tablet) to treat oropharyngeal candidiasis (“OPC”) in patients. ORAVI® is designed to deliver a sustained high therapeutic dose of miconazole directly to the infected site in the mouth.

ORAVI® was developed by the French pharmaceutical company BioAlliance Pharma SA. and was first approved in October 2006 in France. It has since been marketed in two European countries and the U.S., under the tradenames Loramyc®/Oravig®.

Sosei Co. Ltd. obtained the exclusive marketing rights for ORAVI® in Japan from BioAlliance Pharma SA. in May 2011. The New Drug Application for ORAVI® in Japan included data from the original clinical trials and from an additional randomized Phase 3 clinical trial, conducted by Sosei Co. Ltd in Japan that confirmed the safety and efficacy of ORAVI® to be equivalent to an approved formulation of miconazole in OPC patients.

+ Press Releases

- 31 Jan 2019: Sosei Heptares to Launch ORAVI® Mucoadhesive Tablets 50mg for Oropharyngeal Candidiasis in Japan
- 25 Sep 2018: Sosei Announces Approval of ORAVI Mucoadhesive Tablets 50mg for Oropharyngeal Candidiasis in Japan 
- 28 Feb 2017: Sosei announces submission of marketing authorization application of SO-1105 for oropharyngeal candidiasis
- 29 Aug 2016: Sosei announces completion of Japanese Phase III clinical study of SO-1105 for oropharyngeal candidiasis and achievement of principal endpoints
- 4 Feb 2014: Sosei signs distribution agreement with FUJIFILM Pharma for commercialization of SO-1105
- 12 Mar 2013: Sosei announces initiation of Phase III study for SO-1105 for the treatment of oropharyngeal candidiasis
- 2 Jul 2012: Sosei announces successful completion of Phase I study for SO-1105 for the treatment of oropharyngeal candidiasis
- 8 Mar 2012: Sosei Announces Initiation of Phase I study for SO-1105
- 11 May 2011: Sosei Acquires Development and Commercialization Rights to Loramyc from BioAlliance Pharma