Appili to conduct clinical trials of Avigan in North America

By The Science Advisory Board staff writers

October 30, 2020 -- Appili Therapeutics has signed an agreement with Dr. Reddy's Laboratories and Global Response Aid to coordinate and accelerate worldwide development, commercialization, and distribution of favipiravir (Avigan) for the treatment of COVID-19.

Avigan is a broad-spectrum antiviral in oral tablet form. It is approved in Japan as a treatment and stockpile countermeasure for pandemic influenza.

Appili will assume responsibilities for the design and implementation of global clinical programs and related work for multiple phase III trials to support regulatory submissions of the drug for treatment or prevention of COVID-19 in the U.S., Canada, and internationally. The studies will focus on early treatment and postexposure prophylaxis.

The announcement follows a previous global licensing transaction between Dr. Reddy's, Global Response Aid, and Fujifilm Toyama Chemical, the originator of Avigan. Dr. Reddy's and Global Response Aid will continue to be responsible for the research and development, manufacturing, commercialization, and distribution of Avigan. Fujifilm will provide its knowledge base, including clinical data and intellectual property.

Appili will receive a profit share on all U.S. and Canadian sales for a specified term, and the company will be eligible to receive royalties on sales in Europe and Latin America for a specified term.

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