Zydus Cadila€¦ · endpoints in the Phase II clinical studies and showed good safety profile. The...

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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

Transcript of Zydus Cadila€¦ · endpoints in the Phase II clinical studies and showed good safety profile. The...

Page 1: Zydus Cadila€¦ · 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

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

Page 2: Zydus Cadila€¦ · 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

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

Page 3: Zydus Cadila€¦ · 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

Zydus dedicated i /7 Ha

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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