India Approves Avigan® (Favipiravir) for COVID-19 Treatment

Global Response Aid and Dr. Reddy’s to sell premium original version of anti-viral drug

HYDERABAD, India – August 20, 2020Global Response Aid and Dr. Reddy’s Laboratories will begin selling the anti-viral drug Avigan® in India following a recent decision by government health authorities to approve the drug’s active ingredient, Favipiravir, for treatment of patients infected with COVID-19. This important ruling is the result of proven efficacy from the widespread use of the drug.

Avigan® was developed as an influenza anti-viral by FujiFilm, which has licensed GRA and Dr. Reddy’s to manufacture, distribute and sell the drug globally. Clinical trials of the drug have been conducted and are underway in the United States, Japan, China, the Middle East and other countries, where it is being used to reduce fevers and shorten recovery time in patients who receive Avigan® in the early stages of infection with COVID-19.

In India, GRA and Dr. Reddy’s will look to distribute Avigan® through private healthcare providers opting for a premium quality drug. The initial supply will contain the original Avigan®, made in Japan.

“Generic versions of Favipiravir are available on the market in India,” said Eric ten Kate, Head of Life Science GRA. “Our focus is getting branded Avigan®, the premium version of the drug, to providers and patients who prefer the original formulation, which has a higher potency, fewer impurities and five times the shelf life. Our goal is to provide the safest, most effective version of Favipiravir available anywhere.”

Mitch Wilson, CEO of GRA, said: “This is an important milestone in the regulatory approval process for Avigan®. We are expecting further approvals in the near future and will be announcing multiple manufacturing locations globally to meet the growing demand.”

“The diligent and efficient work GRA and Dr. Reddy’s are conducting is the reason we chose them as our partners,” said Junji Okada, President, FUJIFILM Toyama Co., Ltd.

In July, the Central Drugs Standard Control Organisation of India’s Directorate General of Health Services approved Favipiravir for distribution, sale and use in treatment of COVID-19 patients.

Avigan® was approved for manufacture and sale in Japan in 2014 as an influenza anti-viral drug. It has generally been used only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza anti-viral drugs are either not effective or insufficiently effective.

Working with government agencies, non-governmental organizations and local regulatory authorities, GRA is providing Avigan® to qualified patients with COVID-19 on a compassionate-use basis for emergency treatment outside of ongoing clinical studies.

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About Global Response Aid (GRA)

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Global Response Aid, based in Dubai, provides solutions to public health challenges. GRA was established by global logistics leader Agility and AiPHARMA a biotechnology company 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. GRA-sourced products include ventilators, thermal detection equipment, thermometers, masks, goggles, protective suits, nitrile gloves, cleaning and sanitation supplies, and point-of-care test kits. GRA’s mobile phone app helps stop the spread of viruses through the use of community-driven contact tracing and alerts. GRA also deploys Mobile Diagnostic Testing Vehicles and trained teams that perform COVID-19 testing at schools and workplaces.

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About FUJIFILM

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FUJIFILM Toyama Chemical Co., Ltd. conducts the research, development, manufacture, and sales of radiopharmaceuticals and small molecule pharmaceutical products. Under close cooperation with FUJIFILM Corporation, it aims to develop innovative diagnostic and therapeutic radiopharmaceuticals, as well as therapeutic drugs having unique mechanisms of action in the fields of “oncology,” “central nervous system diseases,” and “infectious diseases” where significant unmet medical needs still exist. It also works to develop new medicines utilizing drug delivery system (DDS) technologies, designed to deliver the required amount of a drug in a timely manner to the specific body area. By exploring synergy with in vitro diagnostic devices and reagents owned by Fujifilm group companies, the company will expand its offering of comprehensive solutions from diagnosis to treatment. FUJIFILM Toyama Chemical have expanded its business areas to medical IoT solutions including a system to support pharmacists’ drug dispensing auditing work, and a transportation device that enables strict temperature control suited for blood products, cells and tissue used for regenerative medicine. Through the development and supply of high-quality, high added-value new drugs and products that support the clinical settings, FUJIFILM Toyama Chemical strives to solve various social challenges, and contribute to improving medicine and enhancing the quality of life.

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About Dr. Reddy’s

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About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe.

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