Zydus receives approval from COFEPRIS, Mexico to study Desidustat in the management of COVID-19

Zydus receives approval from COFEPRIS, Mexico to study Desidustat in the management of COVID-19 • Novel mechanism of targeting ‘hypoxia’ through HIF-PH inhibitor will be studied for the first time in Covid-19 • Will conduct a Phase 2b, Multicenter, Open-label, Randomized, Comparator - Controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of COVID-19 patients. • Desidustat, currently undergoing Phase III clinical development*# is a novel oral HIF-PH inhibitor for treating Anemia Ahmedabad, India, July 06, 2020 Zydus, a leading discovery based global pharmaceutical company today announced that it has received approval from the regulatory authority of Mexico, COFEPRIS, for its one of its lead research candidate Desid ustat to be tested in the management of COVID -19. Clinical and regulatory development of Desidustat in COVID -19 is being executed in Mexico by Avant Santé Research Center S.A. de C.V., a leading Contract Research Organization (CRO) headquartered in Monterrey, Mexico. The company will be conducting a Phase 2b, Multicenter, Open -label, Randomized, Comparator- Controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of COVID -19 patients. As a part of the study 100 mg tablet s of Desidustat will be administered for a period of 14 days along with recommended standard care during the trial. Patients infected with COVID-19 have been reported to display signs of ‘Hypoxia’ leading to organ failure and death despite the use of anti virals, anti-inflammatory drugs or ventilators. The attack with the novel coronavirus pneumonia (COVID -19) will cause less and less haemoglobin that can carry oxygen and carbon dioxide. The lung cells have been reported to develop extremely intense poisoni ng and inflammation due to the inability to exchange carbon dioxide and oxygen frequently, which eventually results in ground -glass-like lung images. Desidustat (a hypoxia inducible factor prolyl hydroxylase inhibitor, currently undergoing Phase 3 trials) mimics the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia- inducible factor, and this can lead to increased red blood cell production and improved oxygen delivery to tissues. Speaking on the development, Pankaj R. Patel, Chairman, Zydus Cadila said, “At Zydus, we have been stepping up our efforts to fight the Covid -19 pandemic through therapeutic drugs, diagnostics and vaccines. With Desidustat we will study a novel approach for management of Covid-19.” Zydus had initiated two Phase III trials of Desidustat. The DREAM -ND Phase III trial is being conducted in 588 CKD patients not -on-dialysis*. The DREAM -D Phase III trial is being conducted in 392 CKD patients on Dialysis#. Desidustat had previously met its primary endpoints in the Phase II clinical studies and showed good safety profile. The Phase I trials were earlier completed in Australia. About Zydus Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines. The group employs nearly 25,000 people worldwide, including 1,400 scientist s engaged in R & D, and is dedicated to creating healthier communities globally. www.zyduscadila.com About Avant Santé Avant Santé Research Center S.A. de C.V. through its integrated clinical and regulatory development infrastructure enables drug discovery and drug development companies for the early access to patient and the market. Avant Santé employs nearly 300 people who is dedicated to their vision of fostering health and safety. www.avantsante.com

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