Ocugen, Inc., (NASDAQ: OCGN), a leading biopharmaceutical company,
and Bharat Biotech, a global leader in vaccine innovation, today
announced that the companies have signed a binding letter of intent
(LOI) to co-develop Bharat Biotech’s COVID-19 vaccine candidate,
COVAXIN™, an advanced stage whole-viron inactivated vaccine
candidate, for the United States market.
COVAXIN™ has been evaluated in approximately 1,000 subjects in
Phase 1 and Phase 2 clinical trials in India, with promising safety
and immunogenicity data. The vaccine candidate is currently part of
a Phase 3 clinical trial in India involving 26,000 volunteers.
Per the LOI, Ocugen will have US rights to the vaccine candidate
and, in collaboration with Bharat Biotech, will be responsible for
clinical development, registration, and commercialization for the
US market. The companies have begun collaborating and will finalize
details of the definitive agreement in the next few weeks. This
collaboration leverages Ocugen’s vaccine expertise, and its R&D
and regulatory capabilities in the US.
In preparation for the development of COVAXIN™ in the US, Ocugen
has assembled a Vaccine Scientific Advisory Board featuring leading
academic and industry experts to evaluate the clinical and
regulatory path to approval in the US market.
“COVAXIN™ utilizes a historically proven approach to vaccine
design. The adjuvanted inactivated virus vaccine candidate elicited
strong IgG responses against spike (S1) protein, receptor-binding
domain (RBD) and the nucleocapsid (N) protein of SARS-CoV-2 along
with strong cellular responses in Phase 1 and 2 clinical trials.
COVAXIN™ offers a vaccine candidate that is different from
other options currently available in the US market with potentially
broader coverage against multiple protein antigens of the virus,”
said Harvey Rubin, M.D. Ph.D. of the University of Pennsylvania, a
member of Ocugen’s Vaccine Scientific Advisory Board.
David Fajgenbaum, M.D. of University of Pennsylvania’s Division
of Translational Medicine & Human Genetics, Director of the
Center for Cytokine Storm Treatment & Laboratory, and member of
Ocugen’s Vaccine Scientific Advisory Board said, “The COVID-19
pandemic has caused unmatched devastation to individual patients
and to the world. It is going to take the kind of unmatched
collaboration and innovation that is occurring right now to
effectively fight back. Vaccines such as COVAXIN™ that can
potentially elicit a broad immune response and may limit future
COVID-19 severity could be important to have in our arsenal.”
“We are delighted to collaborate with Bharat Biotech to
potentially bring COVAXIN™ to the US market. In the face of the
coronavirus pandemic, it is incumbent upon all of us to find
solutions that have the potential to save lives and restore
normalcy to our day-to-day activities. We have been very pleased
with the safety and immunogenicity demonstrated by the Phase 1 and
Phase 2 trials of COVAXIN™ and are encouraged with the progress of
the Phase 3 trials in India. We believe this unique yet traditional
approach to vaccination holds great potential to appeal to a broad
range of the population,” said Dr. Shankar Musunuri, Chairman, CEO,
and Co-Founder of Ocugen.
“The development and clinical evaluation of COVAXIN™ marks a
significant milestone for vaccinology in India. COVAXIN™ has
garnered interest from several countries worldwide for supplies and
introduction and we are excited to collaborate with Ocugen to bring
it to the US market,” said Dr. Krishna Ella, Chairman &
Managing Director of Bharat Biotech.
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). This inactivated vaccine is developed and
manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio
containment facility. COVAXIN™ is a highly purified and inactivated
vaccine, manufactured in a vero cell manufacturing platform with an
excellent safety track record of more than 300 million doses
supplied.About Ocugen, Inc.Ocugen, Inc. is a
biopharmaceutical company focused on discovering, developing, and
commercializing transformative therapies to cure blindness
diseases. 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. For more information, please visit
www.ocugen.com.
About Bharat Biotech:Bharat Biotech has
established an excellent track record of innovation with more than
140 global patents, a wide product portfolio of more than 16
vaccines, 4 bio-therapeutics, registrations in more than 116
countries and WHO Pre-qualifications. Located in Genome Valley in
Hyderabad, India, a hub for the global biotech industry, the
company 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 6 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 the introduction of path breaking WHO
pre-qualified vaccines BIOPOLIO ® ROTAVAC® and Typbar TCV®’
combatting polio, rotavirus, typhoid infections respectively. The
recent acquisition of the Rabies vaccine facility, Chiron Behring
from GSK has positioned Bharat as the largest Rabies vaccine
manufacturer in the world. To learn more about Bharat Biotech,
visit www.bharatbiotech.com.
Cautionary Note on Forward-Looking
StatementsThis 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
statements are subject to numerous important factors, risks and
uncertainties that may cause actual events or results to differ
materially from our current expectations. These and other risks and
uncertainties are more fully described in our periodic filings with
the Securities and Exchange Commission (the “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
SubramanianChief Financial Officerir@ocugen.com
Media Contact:For
Ocugen:LaVoieHealthScienceLisa
DeScenzaldescenza@lavoiehealthscience.com+1 978-395-5970
For Bharat Biotech: Sheela Panicker enright@enrightpr.com+91
984-980-9594
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