Generics
Appili Therapeutics Joins Dr. Reddy's, Global Response Aid, and Fujifilm in Advancing Avigan Tablets for the Potential Treatment of COVID-19
30 October 2020 - - Canada-based biopharmaceutical company Appili Therapeutics Inc. (TSX: APLI) (OTCQX: APLIF) has signed a collaboration, development and supply agreement with India-based Dr. Reddy's Laboratories Ltd. (BSE: 500124) (NSE: DRREDDY) (NYSE: RDY) and Global Response Aid, the company said.

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, 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.

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.

Avigan (favipiravir) is a broad-spectrum antiviral in oral tablet form developed by FUJIFILM Toyama Chemical Co., Ltd. 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.

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.

Appili Therapeutics Inc. 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 antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons 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 Fujifilm Toyama Chemical Inc.'s drug Avigan for the potential treatment and prevention of COVID-19.

Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies.

Dr. Reddy's Laboratories is an integrated pharmaceutical company.

Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

Global Response Aid, based in Dubai, was established by global logistics leader Agility to procure and develop certified diagnostic, testing and protective products and services used in the detection, treatment and prevention of COVID-19 and other public health threats.

GRA works with trusted manufacturers to source safe, effective products for governments, health authorities and public institutions; frontline medical facilities; NGOs; and companies looking to safeguard workers and workplaces.

FFTC, Tokyo, Japan is one of the major operating companies of Fujifilm Holdings Corp.
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