Dr. Reddy's and RDIF commence clinical trials for Sputnik V vaccine in India
December 01 2020 - 8:15AM
Business Wire
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY), and Russian Direct Investment Fund (RDIF) announced today
that they have commenced adaptive phase 2/3 clinical trials for
Sputnik V vaccine in India after receiving the necessary clearance
from the Central Drugs Laboratory, Kasauli, India. This will be a
multicenter and randomized controlled study, which will include
safety and immunogenicity study.
The clinical trials are being conducted by JSS Medical Research
as the clinical research partner. Further, Dr. Reddy’s has
partnered with the Biotechnology Industry Research Assistance
Council (BIRAC), Department of Biotechnology (DBT) for advisory
support and to use BIRAC’s clinical trial centres for the
vaccine.
Recently, RDIF announced the second interim analysis of clinical
trial data, which showed 91.4% efficacy for the vaccine on day 28
after the first dose; vaccine efficacy over 95% 42 days after the
first dose. Currently, 40,000 volunteers are taking part in Phase
III of Sputnik V clinical trials, out of which over 22,000 have
been vaccinated with the first dose of the vaccine and more than
19,000 – with both the first and second doses of the vaccine.
G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s
Laboratories said, “This is another significant step as we continue
to collaborate with multiple entities along with the government
bodies to fast-track the process for launching the vaccine in
India. We are working towards making the vaccine available with a
combination of import and indigenous production model.”
In September 2020, Dr. Reddy’s and RDIF entered into a
partnership to conduct clinical trials of the Sputnik V vaccine and
the rights for distribution of the first 100 million doses in
India.
On August 11, 2020, the Sputnik V vaccine 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 human adenoviral vector platform.
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE:
500124, NSE: DRREDDY, NYSE: RDY) 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/20201201005706/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