Solasia Pharma Secures Brazil Sales Approval for Episil

TOKYO, Jul 14 (Pulse News Wire) – Solasia Pharma K.K. (4597.T) announced that Daiichi Sankyo Brasil Farmacêutica Ltda., a subsidiary of Daiichi Sankyo Co., Ltd., completed the regulatory filing for Episil in Brazil.

The Brazilian National Health Surveillance Agency (ANVISA) approved the application on July 13, allowing sales to commence in the fourth quarter of 2023. Episil, designed to manage and alleviate oral pain caused by chemotherapy or radiation therapy, will be sold under the brand name epifilm in Brazil. Episil is a non-absorbable liquid medical device aimed at protecting and healing mucosal lesions in the mouth. It provides quick relief upon application, contributing to cancer patients' treatment continuity and quality of life improvement.

Solasia Pharma holds exclusive global manufacturing and distribution rights for Episil, excluding Japan, China, and South Korea, which have licensed agreements in place. The company expects revenue from product supply to Daiichi Sankyo Brasil to contribute to future earnings. Projected sales revenues for the fiscal year ending December 2026 have been incorporated into previous forecasts released in February. Additionally, Solasia Pharma anticipates milestone payments from Daiichi Sankyo Brasil, though the exact amount remains confidential due to a non-disclosure agreement.