Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on
discovering, developing, and commercializing gene therapies to cure
blindness diseases and developing a vaccine to save lives from
COVID-19, today announced that in a new study, scientists at Indian
Council of Medical Research (ICMR)-National Institute of Virology
have found that COVAXIN demonstrated potential effectiveness
against the Brazil variant of SARS-CoV-2, B.1.128.2. As previously
disclosed, a study conducted by ICMR also suggested that COVAXIN
was effective against the UK variant, B.1.1.7, as well as the
Indian double mutant variant, B.1.617. It is notable that the
Brazilian variant, B1.128.2, contains the E484K mutation that was
found in New York.
In the ICMR studies, COVAXIN-vaccinated sera effectively
neutralized several SARS-CoV-2 variants (B.1.617 (India, double
mutant), B.1.1.7 (United Kingdom), B.1.1.28 (Brazil P2), and
heterologous strain) in an in-vitro plaque reduction neutralization
assay. These studies suggest that COVAXIN vaccination may be
effective against multiple SARS-CoV-2 variants.
A Media Snippet accompanying this announcement is available by
clicking on the image or link below:
“We are pleased to see the results of this study as
it demonstrates the potential effectiveness of COVAXIN against
multiple variants, further strengthening our belief that this
vaccine can potentially eliminate the possibility of mutant virus
escape,” said Dr. Satish Chandran, chair of the vaccine scientific
advisory board of Ocugen.
“COVAXIN continues to show strong results in all the studies
conducted to date. We continue to believe this vaccine is a
critical tool to include in our national arsenal to fight this
pandemic. The Ocugen team submitted a comprehensive drug master
file with the FDA and is currently diligently preparing the EUA
application,” said Dr. Shankar Musunuri, Chairman of the Board,
Chief Executive Officer, and Co-founder of Ocugen.
Ocugen is developing COVAXIN, Bharat Biotech’s COVID-19 vaccine
candidate, for the U.S. market. In the recently shared second
interim results of the Phase 3 clinical trial, COVAXIN demonstrated
78% overall efficacy and 100% in severe COVID-19 disease (including
hospitalization).
About COVAXIN
COVAXIN, India's COVID-19 vaccine by Bharat Biotech, is
developed in collaboration with the Indian Council of Medical
Research (ICMR) - National Institute of Virology (NIV). COVAXIN is
a highly purified and inactivated vaccine that is manufactured
using a vero cell manufacturing platform with an excellent safety
track record of more than 300 million doses supplied.
In addition to generating strong immune response against
multiple antigens, COVAXIN has been shown to generate memory T cell
responses, for its multiple epitopes, indicating longevity and a
rapid antibody response to future infections. With published data
demonstrating a safety profile superior to available data for
several other vaccines, COVAXIN is packaged in multi-dose vials
that can be stored at 2-8⁰C.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on
discovering, developing, and commercializing gene therapies to cure
blindness diseases and developing a vaccine to save lives from
COVID-19. Our breakthrough modifier gene therapy platform has the
potential to treat multiple retinal diseases with one drug – “one
to many” and our novel biologic product candidate aims to offer
better therapy to patients with underserved diseases such as wet
age-related macular degeneration, diabetic macular edema, and
diabetic retinopathy. We are co-developing Bharat Biotech’s
COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For
more information, please visit www.ocugen.com.
About Bharat Biotech
Bharat Biotech has established an excellent track record of
innovation with more than 145 global patents, a wide product
portfolio of more than 16 vaccines, 4 bio-therapeutics,
registrations in more than 123 countries, and the World Health
Organization (WHO) Pre-qualifications. Located in Genome Valley in
Hyderabad, India, a hub for the global biotech industry, Bharat
Biotech has built a world-class vaccine & bio-therapeutics,
research & product development, Bio-Safety Level 3
manufacturing, and vaccine supply and distribution.
Having delivered more than 4 billion doses of vaccines
worldwide, Bharat Biotech continues to lead innovation and has
developed vaccines for influenza H1N1, Rotavirus, Japanese
Encephalitis, Rabies, Chikungunya, Zika, and the world’s first
tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment
to global social innovation programs and public-private
partnerships resulted in introducing path-breaking WHO
pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV®
combatting polio, rotavirus, typhoid infections, respectively. The
acquisition of the rabies vaccine facility, Chiron Behring, from
GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world's
largest rabies vaccine manufacturer. To learn more about Bharat
Biotech, visit www.bharatbiotech.com.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995, which are subject to risks and uncertainties. We may, in some
cases, use terms such as “predicts,” “believes,” “potential,”
“proposed,” “continue,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “will,” “should” or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. Such forward-looking
statements include information about qualitative assessments of
available data, potential benefits, expectations for clinical
trials, and anticipated timing of clinical trial readouts and
regulatory submissions. This information involves risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical endpoints, commencement and/or completion
dates for clinical trials, regulatory submission dates, regulatory
approval dates and/or launch dates, as well as risks associated
with preliminary and interim data (including the Phase 3 interim
data), including the possibility of unfavorable new clinical trial
data and further analyses of existing clinical trial data; the risk
that clinical trial data are subject to differing interpretations
and assessments, including during the peer review/publication
process, in the scientific community generally, and by regulatory
authorities; whether and when data from Bharat Biotech’s clinical
trials will be published in scientific journal publications and, if
so, when and with what modifications; whether the U.S. Food and
Drug Administration (FDA) will be satisfied with the design of and
results from preclinical and clinical studies of COVAXIN, which
have been conducted by Bharat Biotech in India; whether and when
any biologics license and/or emergency use authorization
applications may be filed in the United States for COVAXIN; whether
and when any such applications may be approved by the FDA;
decisions by the FDA impacting labeling, manufacturing processes,
safety and/or other matters that could affect the availability or
commercial potential of COVAXIN in the United States, including
development of products or therapies by other companies. These and
other risks and uncertainties are more fully described in our
periodic filings with the Securities and Exchange Commission (SEC),
including the risk factors described in the section entitled “Risk
Factors” in the quarterly and annual reports that we file with the
SEC. Any forward-looking statements that we make in this press
release speak only as of the date of this press release. Except as
required by law, we assume no obligation to update forward-looking
statements contained in this press release whether as a result of
new information, future events or otherwise, after the date of this
press release.
Ocugen Contact:Ocugen, Inc.Sanjay
SubramanianCFO and Head of Corp. Dev.IR@Ocugen.com
Media Contact: LaVoieHealthScience Lisa
DeScenzaldescenza@lavoiehealthscience.com+1 9783955970
Ocugen (NASDAQ:OCGN)
Historical Stock Chart
From Sep 2024 to Oct 2024
Ocugen (NASDAQ:OCGN)
Historical Stock Chart
From Oct 2023 to Oct 2024