Ocugen, Inc. Provides an Update on its Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN™ (BBV152)
November 26 2021 - 7:01AM
Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on
discovering, developing, and commercializing novel therapeutics and
vaccines, announced that the U.S. Food and Drug Administration
(FDA) has issued a clinical hold on the Company’s Investigational
New Drug application (IND) to evaluate the COVID-19 vaccine
candidate, BBV152, known as COVAXIN™ outside the United States.
The FDA plans to identify the specific deficiencies that are the
basis for clinical hold and information on how to address those
deficiencies. The Company expects to receive formal written
communication with the additional information from
the FDA and plans to work with the FDA in an
effort to resolve its questions as promptly as possible.
About COVAXIN™ (BBV152)COVAXIN™ (BBV152) is an
investigational vaccine candidate product in the U.S. It was
developed by Bharat Biotech 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 more than 100 million doses having been administered to
adults outside the U.S., COVAXIN™ is currently authorized under
emergency use in 17 countries, and applications for emergency use
authorization are pending in more than 60 other countries. The
World Health Organization (WHO) recently added COVAXIN™ to its list
of vaccines authorized for emergency use. And, as many as 110
countries have agreed to mutual recognition of COVID-19 vaccination
certificates with India that includes vaccination using COVAXIN™.
The trade name COVAXIN™ has not been evaluated by the FDA.
As recently published in, The Lancet, COVAXIN™ (BBV152)
demonstrated 77.8% overall efficacy, 63.6% efficacy against
asymptomatic disease and 65.2% efficacy against the Delta variant
in the Phase 3 clinical trial of nearly 25,800 participants.
Adverse events reported in the trial were low, with 12.4% of
subjects experiencing commonly known side effects and less than
0.5% of subjects experiencing serious adverse events, which is
consistent with data from other vaccines that apply whole-virion
technology. Both adverse events and serious adverse events reported
in the vaccine group were reported at similar rates to the placebo
group. The trial was conducted in India and sponsored by Bharat
Biotech.
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. and Canadian
markets. 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
statements about our expectations regarding the status of our Phase
3 clinical trial included in our Investigational New Drug
application (IND) to the U.S. Food and Drug Administration (FDA)
for COVAXIN™, the timing of discussions with the FDA regarding the
current clinical hold and whether or not and under what
requirements, if any, our further clinical development of COVAXIN™
will be permitted by the FDA. 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 risk that we
may not resolve the current clinical hold on COVAXIN™ in the near
term or at all, or that the FDA could make other decisions that
inversely impact our ability to advance the development of COVAXIN™
in the United States, the implications that this clinical hold may
have for our request for emergency use authorization for COVAXIN
for pediatric use; 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 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 we will
be able to provide the FDA with sufficient additional information
regarding the design of and results from preclinical and clinical
studies of COVAXIN™, which have been conducted by Bharat Biotech in
India in order for those trials to support a biologics license
application (BLA) or emergency use authorization (EUA); the size,
scope, timing and outcome of any additional trials or studies that
we may be required to conduct to support a BLA, including our
planned Phase 3 clinical trial which is currently subject to
clinical hold; any additional chemistry, manufacturing and controls
information that we may be required to submit to the FDA; whether
developments with respect to the COVID-19 pandemic will affect the
regulatory pathway available for vaccines in the United States,
Canada or other jurisdictions; decisions by the FDA or Health
Canada impacting labeling, manufacturing processes, safety and/or
other matters that could affect the availability or commercial
potential of COVAXIN™ in the United States or Canada, 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: Ken InchaustiHead,
Investor Relations & Communications+1 484 237
3398ken.inchausti@ocugen.comPlease submit investor-related
inquiries to: IR@ocugen.com
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