Appili Therapeutics Joins Dr. Reddy’s, Global Response Aid, and FUJIFILM in Advancing Avigan Tablets for the Potential Treatment of COVID-19

Consortium brings together world-class and globally coordinated clinical development, commercialization, cGMP manufacturing, and l logistics expertise to accelerate the deployment and availability of Avigan® tablets for the potential treatment and prevention of COVID-19

Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that it has signed a collaboration, development and supply agreement with Dr. Reddy’s Laboratories Ltd. (BSE:500124, NSE:DRREDDY, NYSE:RDY, “Dr. Reddy’s”) and Global Response Aid (“GRA”). This agreement follows on and is harmonized with the previously announced global licensing transaction (excluding Japan, Russia, and China) between DRL, GRA and FUJIFILM Toyama Chemical Co., Ltd. (“FFTC”), the originator of Avigan® tablets. The agreements work together to coordinate and accelerate the worldwide development, commercialization, and distribution of Avigan® tablets (favipiravir) for the potential treatment and prevention of COVID-19.

In joining the global consortium to advance Avigan®, Appili will assume key responsibilities for the design and implementation of the consortium’s global clinical programs and related work, including, but not limited to, the design and implementation of multiple pivotal Phase 3 trials to enable regulatory submission, review, and, if supported by data, approvals for the use of Avigan® tablets in the treatment or prevention of COVID-19 in the US, Canada and internationally. The clinical development strategy will focus on evaluating Avigan® tablets for early treatment and post-exposure prophylaxis in the community setting.

Dr. Reddy’s and GRA  will continue to be responsible for the research and development, manufacturing, commercialization, and distribution of Avigan®. FFTC is the innovator that originally developed Avigan® for use in pandemic influenza and is supplying its knowledge base, including clinical data and intellectual property, in support of the consortium’s operations. In collaboration with its partners, Appili will design and oversee Phase 3 clinical trials to support regulatory submissions worldwide. Appili will be responsible for the US and Canadian clinical trials conducted on behalf of the consortium and will receive a profit share on all US and Canadian sales for a specified term. Appili is also eligible to receive royalties on sales in Europe and Latin America for a specified term.

“To address the ongoing threat of COVID-19 we must not only identify effective agents through rigorous clinical evaluation, we must also ensure they are widely available, which is a particular challenge in COVID-19, where billions of people from every corner of the globe are at risk from this threat,” said Dr. Armand Balboni, Chief Executive Officer at Appili Therapeutics. “This consortium is designed to do just that, with world-class expertise not only in drug development but also in manufacturing and commercialization to support access. We are thrilled to join this group of industry leaders in their global effort, contributing our drug development expertise and extensive experience with Avigan® to accelerate its development on a globally coordinated basis. We look forward to the timely outcomes of our ongoing and soon-to-be initiated late-stage clinical trials to evaluate Avigan® as the first orally available anti-viral treatment option for COVID-19.”

Appili has previously announced a Phase 2 trial evaluating the use of favipiravir to control outbreaks of COVID-19 in long-term care facilities and a Phase 3 trial in the United States evaluating the use of Avigan® for the early treatment of patients with mild-to-moderate COVID-19 symptoms. Working with the consortium, Appili expects to expand its favipiravir clinical programs internationally.

About Avigan® (favipiravir)

Avigan® (favipiravir) is a broad-spectrum antiviral in oral tablet form developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza under the name Avigan®. Following promising clinical studies, Russia and India recently approved favipiravir-based antiviral medications for the emergency treatment of COVID-19.[i] [ii] FFTC recently announced positive Phase 3 data in the use of AVIGAN in hospitalized COVID-19 patients. In a previously announced agreement, Dr. Reddy’s and GRA received a license from FFTC for the manufacturing, development, and commercial rights to favipiravir outside of Japan, China, and Russia.

Additional clinical trials for favipiravir in COVID-19 are ongoing in the United States, China, India, and the United Kingdom. Unlike most other interventions that researchers are evaluating in the COVID-19 indication, favipiravir has already been thoroughly studied in human trials outside of North America and has a known safety profile, with over 3,000 subjects receiving at least one dose of the drug. Favipiravir’s oral tablet form may also provide advantages in the community setting over other COVID-19 interventions, which often require injection or intravenous administration.
Source: Appili Therapeutics Inc.