Dr. Reddy’s Laboratories, Global Response Aid, and Appili Therapeutics Announce the Filing of an Application for REEQONUS™ (favipiravir) Tablets for the Treatment of COVID-19 under Health Canada’s Interim Order

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HYDERABAD, India & MISSISSAUGA, Ontario & HALIFAX, Nova Scotia– Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”), Appili Therapeutics (TSX: APLI, OTCQX: APLIF) and Global Response Aid FZCO (GRA) today announced that Dr. Reddy’s Canada has filed an application on behalf of the consortium for REEQONUS™ (favipiravir) Tablets for the acute treatment of mild to moderate COVID-19 adult patients under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. REEQONUS™ is also known as Avigan® (favipiravir) Tablets, developed by FUJIFILM Toyama Chemical Co., Ltd.

“We are pleased to work with our partners at GRA and Appili to be the first in Canada to file an application for oral solid tablets for COVID-19 treatment under Health Canada’s Interim Order,” says Vinod Ramachandran, Ph.D., Vice President and General Manager, Dr. Reddy’s Laboratories Canada Inc. “Dr. Reddy’s is working closely with Health Canada for an expedited review of the drug application, as speed to market is essential in these unprecedented times. If approved, we look forward to launching this important product soon to benefit the lives and health of COVID-19 patients in Canada.”

“Reaching patients early in the infection to prevent possible progression into more serious forms of this disease remains a critical unmet need in the COVID-19 treatment landscape,” says Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Our role remains to design rigorous trials to obtain the data that identify COVID-19 patients that may benefit from REEQONUS™. We look forward to working with our partners in providing information to Health Canada with the goal of advancing this important innovation for patients.”

“Our outreach to Canada is a part of our global efforts to play an active role in addressing the COVID-19 situation. The filing is a testimony to our commitment of bringing a potential solution to COVID-19 for the Canadian population,” says Mitch Wilson, Chief Executive Officer of GRA.

In September, the Interim Order Respecting the Importation, Sale and Advertising of Drugs for use in Relation to COVID-19 was signed by the Minister of Health in Canada to create a new authorization pathway that will help expedite the authorization of drugs and vaccines for COVID-19. According to Health Canada, REEQONUS™ (favipiravir) Tablets are the first oral solid dosage form submitted under the Interim Order.