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Cipla Ltd. Regulatory Filings 2020

Jun 21, 2020

59275_rns_2020-06-21_95a6ac50-a6af-43a8-bfe9-e94b0f4908a0.pdf

Regulatory Filings

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21[st] June 2020

(1) BSE Ltd (2) National Stock Exchange of India Ltd Listing Department Listing Department Phiroze Jeejeebhoy Towers, Exchange Plaza, 5[th] floor, Dalal Street, Plot no. C/1, G Block, Mumbai - 400 001 Bandra Kurla Complex, Bandra (East), Mumbai - 400 051

Scrip Code: 500087 Scrip Code: CIPLA EQ

  • (3) SOCIETE DE LA BOURSE DE LUXEMBOURG Societe Anonyme 35A Boulevard Joseph II, L-1840 Luxembourg

Sub: Press Release – Cipla launches Cipremi (remdesivir lyophilised powder for injection 100 mg), the only U.S. FDA approved Emergency Use Authorisation (EUA) treatment for patients with severe COVID-19 disease

Dear Sir / Madam,

Please find enclosed press release dated 21[st] June 2020 for the captioned subject.

Kindly acknowledge the receipt

This is for your information and records.

Thanking you,

Yours faithfully,

For Cipla Limited

RAJENDRA CHOPRA Digitally signed by RAJENDRA CHOPRA DN: c=IN, o=Personal, 2.5.4.20=4987ad48c3965cfde78c8ea69e6f40ac91535876f12ba1fa5ba45cc5cc8db6cb, postalCode=122001, st=HARYANA, serialNumber=0be85c0408d0e3afd663669f5314248a72fdcdf34d01d48d472d7cf9262696f6, cn=RAJENDRA CHOPRA Date: 2020.06.21 18:54:06 +05'30'

Rajendra Chopra Company Secretary

Encl.as above

Prepared by: Siddharth

Cipla Ltd.

Regd. Office - Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai 400013, India. Phone : +91 2224826000 Fax : +9122 24826120 Website: www.cipla.com Email : [email protected] Corporate Identity Number: L24239MH1935PLC002380

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Press Release

Cipla launches Cipremi (remdesivir lyophilised powder for injection 100 mg), the only U.S. FDA approved Emergency Use Authorisation (EUA) treatment for patients with severe COVID-19 disease

Mumbai, India. June 21, 2020: Cipla Limited (BSE: 500087; NSE: CIPLA EQ, hereinafter referred to as “Cipla”), today announced the launch of remdesivir under its brand name CIPREMI. The U.S. FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of hospitalized 2019 coronavirus disease (COVID-19) patients. It is the only U.S. FDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalized with suspected or laboratory confirmed COVID-19 infection. In May, Gilead Sciences Inc. extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s generic version of remedisvir called CIPREMI[.]

Cipla has been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need. As part of a risk management plan, Cipla will provide training on use of the drug, informed patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients.

According to a preliminary report from the ACTT-1 (Adaptive COVID-19 Treatment Trial 1) study[1] , a randomized clinical trial conducted with remdesivir in 1063 patients over 60 centres across U.S., Europe and Asia demonstrated a faster time to clinical recovery in hospitalised patients as compared to placebo. Most of these patients were on oxygen therapy of which some were receiving high flow oxygen or non-invasive

ventilation, and some were on a mechanical ventilator. The mortality rates in the study were 7.1% in those given remdesivir and 11.9% in those who were given placebo.

As part of its efforts to enable speedy and equitable access to this treatment and in anticipation of demand, Cipla will be commercialising remdesivir through its own facilities and partnered sites. The drug will be supplied through Government and open market channels, to ensure equitable distribution.

Commenting on the launch, Mr. Umang Vohra (MD and Global CEO, Cipla Limited) said, “Cipla appreciates the strong partnership with Gilead to bring remdesivir to patients in India. We have been deeply invested in exploring all possible avenues to save millions of lives impacted by COVID-19 pandemic, and this launch is a significant milestone in that direction. We will continue to collaborate with all stakeholders in the healthcare ecosystem towards providing access to such promising treatments in furtherance with our belief that no patient should be denied access to life-saving treatments.”

1Source: New Eng J MED 2020, Published on May 22, 2020

About Cipla

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3[rd] largest in pharma in India (IQVIA MAT May’20), 3[rd] largest in the pharma private market in South Africa (IQVIA MAT May’20), and is among the most dispensed generic players in the U.S. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigmchanging offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.

For queries, please contact :

Corporate Communications Investor Relations

Heena Kanal Naveen Bansal

E-Mail: [email protected] E-Mail: [email protected]