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find enclosed a Press Release on "Dr. Reddy's receives approval to conduct Phase 3 clinical trial for Sputnik V
This is for your information.
| /s/ Sandeep Poddar | |
| Sandeep Poddar | |
| Company Secretary |
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
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receives approval to conduct Phase 3 clinical trial for Sputnik V vaccine in India
Hyderabad, India, January 15, 2021: Dr. Reddy's Laboratories
Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) announced today that it has received approval from the Drugs Control
General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India.
The phase 3 study of Sputnik V will be conducted on 1500 subjects
as part of the randomized, double-blind, parallel-group, placebo-controlled study in India.
Earlier, the Data and Safety Monitoring Board (DSMB) reviewed
the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment. In its report, the DSMB
concluded that no safety concerns were identified and the study met the primary endpoints of safety.
G V Prasad, Co-chairman and Managing Director, Dr. Reddy's
Laboratories said, "This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect
to commence the phase 3 study within this month and will continue to fast-track our efforts to bringing in a safe and efficacious
vaccine for the Indian population".
In September 2020, Dr. Reddy's partnered with Russian
Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.
Sputnik V developed by the Gamaleya National Research Institute
of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered
vaccine against COVID-19 based on the established human adenoviral vector platform. The vaccine's efficacy is confirmed at
91.4% based on data analysis of the final control point of clinical trials in Russia. Currently, the vaccine's clinical trials
are underway in the UAE, Egypt, Venezuela and Belarus while it has been registered in Algeria, Argentina, Belarus, Bolivia and
Serbia for inoculation.
About Dr. Reddy's: Dr. Reddy's Laboratories
Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) 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, 2020. The company assumes no obligation to update any information contained herein."