Definitive Agreement provides details of the previously announced intent to co-develop COVAXIN™️ for
the US market
Ocugen and Bharat Biotech to share US commercialization profits
Ocugen to receive initial supply of COVAXIN™️ doses from Bharat Biotech upon authorization from US
regulatory authorities while it ramps up manufacturing in the US
COVAXIN™️ received EUA (Emergency Use Authorization) in India earlier this month and is currently in
a fully enrolled Phase 3 clinical trial involving 25,800 patients
COVAXIN™️ effectively neutralizes UK variant of SARS-Cov-2 reducing the possibility of mutant virus
escape
Malvern, PA & Hyderabad, India—February 02, 2021 Ocugen, Inc., (NASDAQ: OCGN), a
biopharmaceutical company focused on discovering, developing, and commercializing gene therapies
to cure blindness diseases and developing a vaccine to fight COVID-19, and Bharat Biotech, a global
leader in vaccine innovation, today announced they have entered into a definitive agreement to codevelop, supply, and commercialize Bharat Biotech’s COVAXIN™️, an advanced stage whole-virion
inactivated COVID-19 vaccine candidate, for the United States market.
Under the terms of the agreement, Ocugen will have US rights to the vaccine candidate and will be
responsible for clinical development, regulatory approval (including EUA) and commercialization for
the US market. Bharat Biotech will supply initial doses to be used in the US upon Ocugen’s receipt of an
EUA. In addition, Bharat Biotech will support the technology transfer for manufacturing in the US. In
consideration for the exclusive license to the US market, Ocugen will share the profits from the sale of
COVAXIN™️ in the US market with Bharat Biotech, with Ocugen retaining 45% of the profits.
The collaboration will leverage the vaccine expertise of Ocugen’s leadership team. In preparation for
the development of COVAXIN™️ in the US, Ocugen’s Vaccine Scientific Advisory Board and Ocugen
management have initiated discussions with the U.S. Food & Drug Administration (FDA) and the
Biomedical Advanced Research and Development Authority (BARDA) to develop a regulatory path to
EUA and, eventually, biologics license application (BLA) approval in the US market for COVAXIN™️.
Ocugen is also in active discussions with manufacturers in the US to produce a significant number of
doses of COVAXIN™️ to support its US immunization program.
“The evaluation of COVAXIN™️ has resulted in several unique product characteristics including longterm persistence of immune responses to multiple viral proteins, as opposed to only the spike protein,
and has demonstrated broad spectrum neutralizing capability with heterologous SARS-CoV-2 strains,
thus potentially reducing or eliminating escape mutants. Requiring only a standard vaccine storage
temperature of 2-8oC and with the potential to treat all age-groups, COVAXIN™️ may offer an important
option to protect lives across America,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of
Ocugen.
The Central Licensing Authority in India has granted permission for the sale or distribution of
COVAXIN™️ for restricted use in emergency situations in the public interest, in clinical trial mode. With
the kickoff of what is likely to become the biggest national vaccination campaign in India’s history,
COVAXIN™️ is being administered as one of the two COVID-19 shots available under emergency
authorization with the first batch of 30 million doses being administered to health professionals and
front-line workers.
“The COVID-19 pandemic has affected humanity at large. As a company determined to protect global
public health, it has always been important for us to develop vaccines for a global cause. Our goal for
all vaccines developed at Bharat Biotech is to provide global access. COVAXIN™️ has generated
excellent safety data with robust immune responses to multiple viral proteins that persist. With the
recent progression of COVAXIN use under EUA in India, I am confident that we will be able to work
with Ocugen to develop a plan to bring COVAXIN 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). 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™️ is 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 several
other vaccines, COVAXIN™️ is packaged in multi-dose vials that can be stored at 2-8oC.
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 fight 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 US 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 140 global
patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more
than 116 countries, and 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 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 GlaxoSmithKline (GSK) has positioned Bharat Biotech as the
largest rabies vaccine manufacturer in the world. To learn more about Bharat Biotech visit
www.bharatbiotech.com
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