Dr. Reddy’s Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India
16 January 2021 - 4:33AM
Business Wire
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210115005495/en/
INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com (PH:
+91-40-49002135)
MEDIA RELATIONS APARNA TEKURI aparnatekuri@drreddys.com
(PH: +91-40- 49002446)
Dr Reddys Laboratories (NYSE:RDY)
Historical Stock Chart
From Mar 2024 to Apr 2024
Dr Reddys Laboratories (NYSE:RDY)
Historical Stock Chart
From Apr 2023 to Apr 2024