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Sosei Announces Initiation of Phase I Study for SO-1105
Date:3/7/2012

TOKYO, March 8, 2012 /PRNewswire/ --

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), the biopharmaceutical company, today announces that its wholly owned Japanese subsidiary, Sosei Co., Ltd., has initiated a Japanese Phase I trial for SO-1105 for the treatment of oropharyngeal candidiasis. 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 26 European countries, in South Korea, and in the United States, under the trade names Loramyc®/Oravig®.

The clinical study will be conducted in a single study centre in Japan, and is designed to evaluate the pharmacokinetics and safety of SO-1105 in healthy Japanese adults.

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.

Shinichi Tamura, CEO of Sosei Group Corporation, commented: "This is an important step forward in development of SO-1105. We will continue with our efforts to bring SO-1105 to the Japanese market, as it has the potential to provide meaningful benefits to OPC patients compared to existing treatments."

Notes for Editors:

About Oropharyngeal Candidiasis

Fungal infections of the oral mucosa are most frequently caused by Candida species, with C. albicans being the most common species associated with such infections. Oropharyngeal candidiasis is commonly found in immuno-compromised patients, including HIV and cancer patients, and in other chronic disease states such as diabetes. For instance, oropharyngeal candidiasis
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