Tokyo, Japan and London, UK, 25 September 2018 – Sosei Group Corporation (“Sosei” or the “Company”; TSE Mothers Index: 4565) announces that its wholly-owned Japanese subsidiary Sosei Co., Ltd., has received the approval in Japan for ORAVI® Mucoadhesive Tablets 50mg.
ORAVI® (Investigational Code SO-1105) is a novel formulation of the Japanese pharmacopeia miconazole (antifungal agent), the once-daily treatment mucoadhesive tablet to treat oropharyngeal candidiasis (“OPC”) in patients. Lauriad™, the proprietary technology is applied for ORAVI® to extendedly deliver high concentration of miconazole level directly in infected site of mouth.
Sosei Co. Ltd has granted an exclusive license to Fujifilm Group for the commercialization of ORAVI® in Japan. Sosei will receive a milestone payment of JPY 200 million (approximately USD 1.78 million equivalent) from the company for approval and is entitled to receive royalties on sales in Japan, plus additional payments based on the achievement of further sales-based milestones.
ORAVI® was developed by the French pharmaceutical company BioAlliance Pharma SA. and was first approved in October 2006 in France. It has since been marketed in 2 European countries and the United States, under the tradenames Loramyc®/Oravig®.
Sosei Co. Ltd. obtained the exclusive marketing rights for ORAVI® in Japan from BioAlliance Pharma SA. in May 2011. The New Drug Application for ORAVI® in Japan included data from the original clinical trials and from an additional randomized Phase 3 clinical trial, conducted by Sosei Co. Ltd in Japan that confirmed the safety and efficacy of ORAVI® to be equivalent to an approved formulation of miconazole in OPC patients.
Tadayoshi Yasui, representative Director & President of Sosei Co., Ltd., said: “We are pleased to receive this approval for ORAVI® in Japan, which now paves the way forward for its launch in the coming months. We are grateful to the clinical investigators, hospital staff and patients who made this approval possible through their participation in our clinical development program. We are confident that ORAVI®, which is planned to be sold through our partner FUJIFILM has the potential to become a successful new treatment for patients.”
The effect of the approval on our outlook for the accounting period ending December 2018 is expected to be minor.