Full Press Release Details
Ocugen, Inc. Provides an Update on its Investigational
Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating
COVID-19 Vaccine Candidate COVAXIN
MALVERN, Pa., November 26, 2021 - 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.
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.
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.
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
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.
Head, Investor Relations & Communications
Please submit investor-related
inquiries to: IR@ocugen.com