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

HYDERABAD, India & MISSISSAUGA, Ontario & HALIFAX, Nova Scotia--(BUSINESS WIRE)--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.


Avigan® is a trademark of FUJIFILM Toyama Chemical Co., Ltd.


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. For more information, log on to:www.drreddys.com.


Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2019. The company assumes no obligation to update any information contained herein.”


About FUJIFILM Corporation: FUJIFILM Corporation, Tokyo, Japan, is one of the major operating companies of FUJIFILM Holdings Corporation. The company brings cutting-edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to various fields, including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: holdings.fujifilm.com.


About Global Response Aid (GRA): Agility (KSE/DFM: AGLTY), one of the world’s leading logistics companies, and AiPharma, an innovative pharma research, development and commercialization company based in Dubai, established Global Response Aid (GRA) to address the market challenges created by the COVID-19 pandemic and other threats to public health. GRA delivers innovative, effective healthcare solutions through a range of pharmaceutical products and technology platforms. It works closely with governments, regulatory authorities, hospitals, clinics, healthcare providers, life sciences companies, NGOs and public institutions to develop strategies that allow them to tackle public health challenges. For more information: www.globalresponseaid.com, www.agility.com.


About AiPharma: AiPharma is an early-stage biotechnology company with regional offices in Dubai and Tokyo. We take a highly interdisciplinary approach to science, with our services building upon work from leading academic labs in biophysics and algorithmic design that enables the acceleration of life science research and development in the pursuit of improved human health. For more information: www.aipharmalab.com.


About Appili Therapeutics: Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan® (favipiravir) for the worldwide treatment and prevention of COVID-19. The Company is also advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.


Appili Forward-Looking Statements

This news release contains “forward-looking statements,” which reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities, including statements with respect to: the design, scope and parameters of the proposed REEQONUS™ (favipiravir) clinical trials and the likelihood that such clinical trials will be initiated or consummated on the terms and timeline provided herein or at all; the anticipated timing for the release of study data; the potential use of REEQONUS™ (favipiravir) for the treatment of COVID-19 (including as an early treatment of COVID-19 to control disease progression and limit virus spread); and the development, manufacturing and commercialization plans of the parties with respect to REEQONUS™ (favipiravir). Wherever possible, words such as “may,” “would,” “could, “ “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to: securing all requisite required approvals and funding for the applicable clinical trials; finalizing mutually acceptable clinical trial agreement and related agreements with the applicable clinical research organizations relating to the applicable clinical trials; site and patient enrolment; other expectations and assumptions concerning the proposed clinical trials (including with respect to timely completion of such trials and their potential outcomes and benefits); and the ability of the parties to successfully develop, manufacture and commercialize favipiravir for the treatment of COVID-19 following successful completion of the requisite clinical trials and receipt of all requisite regulatory and other approvals. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct.


Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, economic, competitive, political and social uncertainties; known and unknown risks and liabilities relating to the ongoing COVID-19 pandemic; risks relating to the inability of Appili to initiate or complete all requisite clinical trials (including risks relating to the outcome thereof) and to secure all required funding and approvals relating thereto; risks relating to the development, manufacturing and commercialization of REEQONUS™ (favipiravir) in Canada, the U.S and other jurisdictions; unforeseen events, developments, or factors causing any of the aforesaid expectations and assumptions not to be correct; and the other risk factors listed in the ann