Press release
Mar 12, 2013

Sosei announces initiation of Phase III study for SO-1105 for the treatment of oropharyngeal candidiasis

Tokyo, Japan – 12 March 2013: Sosei Group Corporation (TSE Mothers Index: 4565), the biopharmaceutical company, today announces that its Japanese subsidiary, Sosei Co., Ltd., has initiated a Phase III trial for SO-1105 for the treatment of oropharyngeal candidiasis.

The study is an open-label, randomised, multiple centres, parallel-group design (with open active comparator miconazole gel), and will assess efficacy and safety of SO-1105.

SO-1105 is an antifungal agent, administered as a muco-adhesive buccal tablet for the treatment of oropharyngeal candidiasis in immunocompromised patients. SO- 1105 has the potential to become the first long-acting, sustained-release treatment in tablet form for oropharyngeal candidiasis in Japan that could enhance patients’ compliance and quality of life.

SO-1105 was originally developed by a French pharmaceutical company, BioAlliance Pharma, which received its first marketing authorization for SO-1105 in France in October 2006. SO-1105 has since been registered in 24 European countries, in South Korea, and in the United States, under the trade names Loramyc®/Oravig®.

Shinichi Tamura, CEO of Sosei Group Corporation, commented: "This is an important step forward in development of SO-1105. With its once-daily mucoadhesive administration, SO-1105 is expected to improve compliance and patients' quality of life.”