EMERYVILLE, Calif. and
HYDERABAD, India, July 6, 2021 /PRNewswire/ -- Dynavax
Technologies Corporation (Dynavax, Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines and Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical
company, today announced the execution of a commercial supply
agreement of Dynavax's CpG 1018TM advanced adjuvant, for
use in BE's subunit COVID-19 vaccine candidate, CORBEVAX™. The
commercial supply agreement extends through 2022. The agreement
includes doses for delivery in 2021, which were manufactured under
the previously announced funding agreement between the Coalition
for Epidemic Preparedness Innovations (CEPI) and Dynavax. Pending
conditional regulatory approvals in India, BE expects to commence product launch
of CORBEVAX™ later this year.
In June 2021, India's Union Ministry of Health announced
that it had finalized arrangements with BE to reserve 300
million doses of CORBEVAX™. The arrangement with BE is part of
the wider endeavor from the Government of India to encourage indigenous vaccine
manufacturers by providing financial support.
Ryan Spencer, Chief Executive
Officer of Dynavax commented, "Dynavax is proud to extend our
collaboration with Biological E with a commercial supply agreement
and deliver significant amounts of CpG 1018 in hopes that
CORBEVAX™ will be an important COVID-19 vaccine protecting
people globally regardless of income level."
"We are pleased to collaborate with Dynavax, and our
collaboration will produce yet another vital vaccine against the
spread of COVID-19. We believe CORBEVAX™ will play a critical
role in eradicating the global pandemic," said Ms. Mahima Datla, Managing Director, Biological E.
Limited.
About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B
Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine
approved by the U.S. Food and Drug Administration (FDA) and the
European Commission. Dynavax developed CpG 1018 adjuvant to provide
an increased vaccine immune response, which has been demonstrated
in HEPLISAV-B. CpG 1018 adjuvant provides a well-developed
technology and a significant safety database, potentially
accelerating the development and large-scale manufacturing of a
COVID-19 vaccine.
About Dynavax
Dynavax is a commercial stage biopharmaceutical company
developing and commercializing novel vaccines. The Company's first
commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], is approved in the U.S. and the European Union for
prevention of infection caused by all known subtypes of hepatitis B
virus in adults age 18 years and older. Dynavax is also advancing
CpG 1018 adjuvant as a premier vaccine adjuvant through research
collaborations and partnerships. Current collaborations are focused
on adjuvanted vaccines for COVID-19, pertussis and universal
influenza. For more information, visit www.dynavax.com and follow
the company on LinkedIn.
About Biological E. Limited
Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals &
Biologics Company founded in 1953, is the first private sector
biological products company in India and the first pharmaceutical company in
Southern India. BE develops,
manufactures and supplies vaccines and therapeutics. BE supplies
its vaccines to over 100 countries and its therapeutic products are
sold in India and the USA. BE currently has 8 WHO-prequalified
vaccines in its portfolio.
In recent years, BE has embarked on new initiatives for
organizational expansion such as developing generic injectable
products for the regulated markets, exploring synthetic biology and
metabolic engineering as a means to manufacture APIs sustainably
and developing novel vaccines for the global market.
For further details, please visit www.biologicale.com and follow
us on Facebook, LinkedIn and Twitter.
Forward-Looking Statements
This press release contains "forward-looking" statements,
including statements regarding the potential to develop a COVID-19
vaccine containing CpG 1018 adjuvant, the timing and amount of
potential sales to Biological E and timing of regulatory approvals
and the potential to help eradicate the COVID-19 pandemic. Actual
results may differ materially from those set forth in this press
release due to the risks and uncertainties inherent in vaccine
research and development, including the timing of completing
development, whether CpG 1018 combined with the antigen in BE's
subunit vaccine candidate will prove to be beneficial in clinical
trials, whether use of CpG 1018 will reduce the amount of antigen
required per dose, whether and when the vaccine will be approved
for use, protection rates realized and whether sufficient
quantities of CpG 1018 and of vaccine will be able to be
manufactured, as well as other risks detailed in the "Risk Factors"
section of our Annual Report on Form 10-K for the fiscal year ended
December 31, 2020, as well as
discussions of potential risks, uncertainties and other important
factors in our other filings with the U.S. Securities and Exchange
Commission. We undertake no obligation to revise or update
information herein to reflect events or circumstances in the
future, even if new information becomes available. Information on
Dynavax's website at www.dynavax.com is not incorporated by
reference in our current periodic reports with the SEC.
Contacts:
Dynavax
|
Biological E.
Limited
|
Nicole Arndt, Senior
Manager, Investor Relations
|
Vijay Amruth Raj K.,
Lead, Corporate Communications
|
narndt@dynavax.com
|
vijay.kammari@biologicale.com
|
510-665-7264
|
+91 83740
77433
|
|
www.biologicale.com/news
|
Derek Cole,
President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
|
|
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SOURCE Dynavax Technologies