Solasia Pharma K.K. announcedthat Solasia and Meiji Seika Pharma Co. Ltd., have entered into a license and distribution agreement for the commercialization of episil® (SP-03) in Japan.
Under the terms of this agreement, Solasia will target to obtain approval for episil® for local treatment of pain associated with oral mucositis (OM) in Japan and thereafter Meiji will commercialize, distribute and promote episil®. In consideration of the license granted to Meiji, Solasia will receive upfront and milestone payments, as well as tiered royalties.
Solasia has obtained an exclusive license to develop and commercialize episil® in Japan and China from Camurus AB.
In 2016, Solasia filed for New Medical Device Application for episil® (SP-03) in Japan and China.
episil® oral liquid represents a unique and innovative concept for local treatment of pain associated with oral mucositis (OM).
Having been developed using the award-winning* Camurus proprietary technology FluidCrystal®, episil® is administered as lipid-based liquid that spreads on the intraoral mucosal surfaces and transforms to strongly bioadhesive film, which physically protects the sensitized and sore mucosa of the oral cavity.
episil® has clinically demonstrated to rapidly (within minutes) and effectively reduce oral pain for up to 8 hours. episil® oral liquid is the only product for OM that is supplied as a ready-to-use, pocket-sized device helping patients maintain their quality of life while undergoing cancer therapy.
episil® was first launched in Europe in 2009 and is today commercially available in a number of countries, including the U.S. where it was launched by key global pharmaceutical players. episil® oral liquid is a medical device class 1 in Europe and a 510(k) registered medical device in the U.S.
*FluidCrystal® was awarded the “Best innovation in formulation” prize at the CPhI Worldwide in 2013
Source: Business Wire