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EISAI ENTERS INTO LICENSE AGREEMENT FOR FOSRAVUCONAZOLE IN ASIA/OCEANIA WITH SATO PHARMA

°®¶¹´«Ã½. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the company has entered into a license agreement regarding the development and commercialization rights for the antifungal agent fosravuconazole in the Asia/Oceania region* with Sato Pharmaceutical Co., Ltd. (Headquarters: Tokyo, “Sato Pharma”). Under this agreement, Eisai exclusively licenses the intellectual property rights of fosravuconazole in the given countries/regions to Sato Pharma.

 

Ravuconazole, the active ingredient of fosravuconazole, is an antifungal agent discovered and developed by Eisai. Fosravuconazole is a prodrug of ravuconazole, which improves its solubility and bioavailability. In Japan, Seren Pharma (Headquarters: Tokyo) and Sato Pharma have developed fosravuconazole based on the exclusive rights to develop, commercialize, and sublicense granted by Eisai. The treatment has been marketed by Sato Pharma as the oral antifungal agent Nailin® for the indication of “onychomycosis” since July 2018, which Eisai is co-promoting.

 

Under the terms of the agreement, Eisai will receive a contractual upfront payment, and the rights to receive regulatory milestone payments and royalties based on sales over a certain period. Eisai will retain development and commercialization rights related to mycetoma, a neglected tropical disease, and its associated conditions, as these are excluded from the licensing.

 

Upon the conclusion of this agreement, Eisai hopes to maximize the value of fosravuconazole in the Asia/Oceania region, ensuring the earliest possible contribution to patients in need of the medicine.

 

*10 ASEAN nations, Australia, New Zealand, South Korea, and Taiwan

 

 

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[Notes to editors]

  1. 1. °®¶¹´«Ã½ Fosravuconazole

Fosravuconazole is a novel oral antifungal component discovered and developed by Eisai. Fosravuconazole is a prodrug that improves the solubility and bioavailability of ravuconazole, the main active ingredient. When administered to humans, it is rapidly converted to ravuconazole. Ravuconazole demonstrates antifungal activity by inhibiting ergosterol biosynthesis, a membrane component of fungal cells.

In 2010, Eisai concluded a license agreement with Seren Pharma, granting them exclusive rights to develop, commercialize, and sublicense the agent in Japan. In 2014, Seren Pharma concluded an agreement with Sato Pharma, granting them the development and commercialization rights, and both companies continued to develop the agent as a treatment for onychomycosis. In January 2018, Sato Pharma received marketing authorization for the treatment, which led to its market launched as NAILIN 100mg Capsule in July 2018. Eisai is co-promoting the product.

Eisai is also jointly developing fosravuconazole as a novel treatment for mycetoma, one of the neglected tropical diseases, with the not-for-profit research and development organization Drugs for Neglected Diseases initiative (DNDi). Preparations for regulatory filing in Sudan, one of the countries with the highest prevalence of the disease, are currently underway following the completion of clinical studies in the state.