Sosei Co., Ltd., the Japanese subsidiary of Sosei Group Corporation, has signed a distribution agreement for commercialization of SO-1105 in Japan with Fujifilm Pharma Co., Ltd. Fujifilm Pharma aims to help enhance people’s quality of life by development and sales of ethical pharmaceutical products of Fujifilm group.

SO-1105 is an anti-fungal agent, administered as a muco-adhesive buccal tablet for the treatment of oropharyngeal candidiasis in immunocompromised patients. It 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. Sosei K.K. acquired exclusive development and commercialization rights in Japan from BioAlliance in May 2011.

Under the terms of the agreement with Fujifilm Pharma, Sosei K.K. will be responsible for registration, manufacturing and supply, and Fujifilm Pharma for marketing and distribution of SO-1105. Based on this agreement, Sosei K.K. Is entitled to receive a total of 900 million yen for key initial payment and achieved development and regulatory milestones, as well as margin on the sales of SO-1105 to Fujifilm Pharma. Additional payments may also be received upon achievement of sales-based milestones.

We believe that the distribution agreement with Fujifilm Pharma, which has expertise in infectious diseases, will help us expand the reach of SO-1105 to more oropharyngeal candidiasis patients.

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.

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.