Zydus Cadila€¦ · endpoints in the Phase II clinical studies and showed good safety profile. The...
Transcript of Zydus Cadila€¦ · endpoints in the Phase II clinical studies and showed good safety profile. The...
Zydus Cadila caveats ie Healthcare Ltd.
July 6, 2020
Listing Department Code: 532321
BSE Limited
P J Towers, Dalal Street, Fort,
Mumbai — 400001
Listing Department Code: CADILAHC
NATIONAL STOCK EXCHANGE OF INDIA LIMITED
Exchange Plaza, Bandra Kurla Complex,
Bandra (E),
Mumbai — 400051
Re.: Press Release
Dear Sir / Madam,
Please find enclosed a Press Release dated July 6, 2020 titled “Zydus receives approval from
COFERIS, Mexico to study Desidustat in the management of COVID-19”.
The contents of the Press Release give full details.
Please bring the aforesaid news to the notice of the members of the exchange and investors’ at
large.
Thanking you,
Yours faithfully,
_
DHAVAL N. SONI
COMPANY SECRETARY
Encl.: As above
Regd. Office: “Zydus Corporate Park” Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Anmedabad — 382481.
Phone: +91-07971800000, +91-79-48040000 www.zyduscadila.com CIN: L24230GJ1995PLCO25878
Zydus dedicated et ia
Praes Release
Piess Release Press nelease
Zydus receives approval from COFERIS, 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 II 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 Desidustat 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 tablets 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 antivirals, 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 poisoning 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.”
Cadila Healthcare Limited
For further information please contact : ‘Zydus Tower’, Satellite Cross Roads, Anmedabad 380 015. India. The Corporate Communications Department Phone : +91-79-2686 8100 (20 Lines) Fax : +91-79-2686 2365 www.zyduscadila.com
CIN : L24230GJ1995PLC025878
Zydus dedicated i /7 Ha
‘Pea watbedien,
Press Release Press Release
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 scientists 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
Cadila Healthcare Limited
For further information please contact : ‘Zydus Tower’, Satellite Cross Roads, Anmedabad 380 015. India. The Corporate Communications Department Phone : +91-79-2686 8100 (20 Lines) Fax : +91-79-2686 2365 www.zyduscadila.com
CIN :L24230GJ1995PLC025878