Appili joins consortium for Avigan tablet development
2020-10-30 09:50 ET - News Release
Dr. Armand Balboni reports
APPILI THERAPEUTICS JOINS DR. REDDY'S, GLOBAL RESPONSE AID, AND FUJIFILM IN ADVANCING AVIGAN TABLETS FOR THE POTENTIAL TREATMENT OF COVID-19
Appili Therapeutics Inc. has signed a collaboration, development and supply agreement with Dr. Reddy's Laboratories Ltd. 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 co-ordinate 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 United States, Canada and internationally. The clinical development strategy will focus on evaluating Avigan tablets for early treatment and postexposure 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 U.S. and Canadian clinical trials conducted on behalf of the consortium and will receive a profit share on all U.S. 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 co-ordinated 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 anti-viral in oral tablet form developed by 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 anti-viral medications for the emergency treatment of COVID-19. 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 licence 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 continuing 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.
About Appili Therapeutics Inc.
Appili Therapeutics was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad-spectrum, clinical-stage anti-fungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapon threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against gram-negative superbugs; and ATI-1501, which employs Appili's proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the company is also testing FFTC's drug Avigan for the potential treatment and prevention of COVID-19. Headquartered in Halifax, N.S., with offices in Toronto, Ont., Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies.
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