Sosei Announces Initiation of Phase III Study for SO-1105 for the Treatment of Oropharyngeal Candidiasis

TOKYO, March 12, 2013 /PRNewswire/ --

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."

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 is the most frequently occurring infection in head and neck cancer patients undergoing radiation therapy. The clinical presentation of oropharyngeal candidiasis is variable with symptoms including soreness, burning, and/or altered taste. The signs of clinical candidiasis usually include white pseudomembraneous plaques and patches (thrush), erythematous lesions or occasionally angular cheilitis. Left untreated, the condition may progress to involve the esophagus or to more serious systemic complications.

About Sosei

Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets.

For further information about Sosei, please visit http://www.sosei.com.

About BioAlliance Pharma

Dedicated to cancer and supportive care - cancer related pathologies, chemotherapy and radiotherapy-induced complications and opportunistic infections in immunocompromised patients - BioAlliance conceives and develops innovative products, especially in the hospital setting and for orphan or rare diseases.

For more information, visit the BioAlliance Pharma web site at http://www.bioalliancepharma.com.


SOURCE Sosei Group Corporation




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