Ocugen, Inc. to Commercialize COVAXIN™ in Mexico, Rights Now Encompassing All of North America
April 18 2022 - 7:11AM
Ocugen, Inc. (“Ocugen”) (NASDAQ: OCGN), a biotechnology company
focused on discovering, developing, and commercializing novel gene
therapies, biologicals and vaccines, and Bharat Biotech (BBIL), a
global leader in vaccine innovation, today announced that they have
entered into an amendment to their Co-development, Supply and
Commercialization Agreement to expand Ocugen’s exclusive territory
to include commercialization of COVAXIN™ in Mexico. This gives
Ocugen COVAXIN™ commercialization rights for all of North America.
“We’re excited to commercialize COVAXIN™ in Mexico, as
authorities there have made conquering this pandemic a major
priority. After meeting with Mexico’s Secretary of Foreign Affairs,
Marcelo Ebrard, in Delhi, we are encouraged by the role
COVAXIN™ can play in Mexico’s continuing efforts to defeat the
COVID-19 pandemic. COVAXIN™ is currently under review by COFEPRIS
(Comisión Federal para la Protección contra Riesgos Sanitarios) for
emergency use among children between 2 and 18 years of age, and
Ocugen is prepared to collaborate with the public health community
to help their efforts. We also thank Bharat Biotech for helping
make this opportunity a reality,” said Dr. Shankar Musunuri,
Chairman of the Board, Chief Executive Officer and Co-founder of
Ocugen, Inc.
COVAXIN™ can be an ideal vaccination option for Mexico at this
stage of the pandemic. As a whole virion, inactivated vaccine, it
elicits robust cellular immune memory to SARS-CoV-2 and Variants of
Concern. It offers logistical advantages that could support vaccine
access in hard-to-reach communities.
“We are delighted to announce our partnership with Ocugen for
Mexico, along with the United States and Canada. COVAXIN™ is a safe
and efficacious inactivated vaccine for all age groups as evident
from its data from global introduction. We are fully supportive of
team Ocugen in our endeavor to expedite technology transfer
activities towards commercial scale manufacturing of COVAXIN™ in
North America,” said Dr. Krishna Ella, Chairman and Managing
Director, Bharat Biotech.
The license extension between Ocugen and Bharat Biotech with
respect to commercialization in Mexico includes the same profit
share structure as in the United States.
About COVAXIN™ (BBV152)COVAXIN™ is a whole
virion, inactivated vaccine that combines an inactivated SARS-CoV-2
antigen with an adjuvant (6μg + Algel–IMDG[TLR7/8]). 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
supplies of more than 350 million doses globally for adults and
children, COVAXIN™ is currently authorized under emergency use in
more than 25 countries, including Mexico, and applications for
emergency use authorization are pending in more than 60 other
countries. The World Health Organization (WHO) 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™.
About Ocugen, Inc.Ocugen, Inc. is a
biotechnology company focused on discovering, developing, and
commercializing novel gene therapies, biologicals and vaccines that
improve health and offer hope for people and global communities. We
are making an impact through courageous innovation, taking science
in new directions in service of patients. Our breakthrough modifier
gene therapy platform has the potential to treat multiple diseases
with one drug and we are advancing research in other therapeutic
areas to offer new options for people with unmet medical needs.
Discover more at www.ocugen.com and follow us
on Twitter and LinkedIn.
About Bharat BiotechBharat 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)
Prequalifications. 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 5 billion doses of
vaccines worldwide, Bharat Biotech continues to lead innovation and
has developed vaccines for influenza H1N1, Rotavirus, Japanese
Encephalitis (JENVAC®), Rabies, Chikungunya, Zika, Cholera, 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®, ROTAVAC 5D®, and
Typbar TCV® combatting polio, rotavirus, typhoid infections,
respectively. As a leader of pandemic vaccines, Bharat Biotech has
successfully delivered COVAXIN®, India’s 1st indigenous vaccine
against COVID-19. In November 2021, COVAXIN® received WHO EUL.
The acquisition of Chiron Behring Vaccines has positioned Bharat
Biotech as the world's largest rabies vaccine manufacturer with
Chirorab® and Indirab®. 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.
Such forward-looking statements within this press release include,
without limitation, Ocugen’s plans with respect to development and
commercialization of COVAXIN™ in Mexico. Ocugen 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, such as market and other conditions. These
and other risks and uncertainties are more fully described in
Ocugen’s 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
Ocugen makes in this press release speak only as of the date of
this press release. Except as required by law, Ocugen assumes 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 &
Communicationsken.inchausti@ocugen.com
Please submit investor-related inquiries
to: IR@ocugen.com
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