Press release
Feb 28, 2017

Sosei announces submission of marketing authorization application of SO-1105 for oropharyngeal candidiasis

Tokyo, Japan – 28 February 2017: Sosei Group Corporation (TSE Mothers Index: 4565) hereby announces that its Japanese subsidiary Sosei Co. Ltd. has submittted a New Drug Application for the marketing in Japan of SO-1105 (miconazole 50 mg, muco-adhesive tablet) for the treatment of oropharyngeal candidiasis yesterday.

SO-1105 is a novel formulation of the antifungal agent miconazole, administered for the first time in Japan as a once-daily muco-adhesive tablet for the treatment of oropharyngeal candidiasis in the patients such as immunocompromised. It has the potential to offer a new treatment option, as release of the active component is local and sustained thereby increasing the convenience for patients. Loramyc® (SO-1105 in Japan) was developed by Onxeo SA (referred to hereafter as “Onxeo”), formerly known as BioAlliance Pharma SA.

The product is commercialized in the US under the name of Oravig® and in Europe under the name of Loramyc®. The proprietary technology used for SO1105 development, called Lauriad™, has been developed to provide high concentrations of the active ingredient directly at the site of infection. Sosei Co. Ltd. obtained the exclusive marketing rights for SO-1105 in Japan from Onxeo in May 2011 and has already entered into an exclusive contract for marketing and commercialization with Fujifilm Pharma Co., Ltd.