Press release
Jan 31, 2019

Sosei Heptares to Launch ORAVI® Mucoadhesive Tablets 50mg for Oropharyngeal Candidiasis in Japan

Tokyo, Japan and London, UK, 31 January 2019 – Sosei Group Corporation (“the Company”; TSE: 4565), announces its wholly-owned Japanese subsidiary Sosei Co., Ltd. (“the Business”), will launch ORAVI® Mucoadhesive Tablets 50mg in Japan on 4 February 2019.

ORAVI® is a novel once-daily mucoadhesive tablet formulation of the antifungal agent miconazole for the treatment of oropharyngeal candidiasis (“OPC”), a condition that occurs frequently in immunocompromised patients. ORAVI® has been designed to deliver a sustained therapeutic concentration of miconazole directly in the mouth.

The Business received marketing approval in Japan for ORAVI® Mucoadhesive Tablets 50mg on 21 September 2018, after having gained the exclusive marketing rights for ORAVI® in Japan from the French pharmaceutical company BioAlliance Pharma SA in May 2011. ORAVI® was first approved in October 2006 in France. It is currently marketed in two European countries and the United States under the trade names Loramyc®/Oravig®.

Sosei Co., Ltd. has granted an exclusive license to FUJIFILM Toyama Chemical Co., Ltd. for the commercialization of ORAVI® in Japan. The Business is entitled to receive royalties on sales in Japan from FUJIFILM Toyama Chemical, plus additional payments based on the achievement of further sales-based milestones.

Tadayoshi Yasui, Representative Director & President of Sosei Co., Ltd., said: “We are pleased to announce the launch of ORAVI® in Japan. We are confident that ORAVI® has the potential to become a successful new treatment for patients suffering with OPC by making use of its locally administered and sustained-release characteristics to maximize the efficacy of miconazole. ORAVI® will be sold by FUJIFILM Toyama Chemical, and we look forward to working with them to support the commercialization of ORAVI® and to contribute to improving the health and quality of life for patients.”

The effect of the launch on our outlook for the accounting period ending December 2019 is expected to be minor.