Dynavax and Biological E Announce Commercial Supply Agreement of Dynavax's CpG 1018 Adjuvant for Biological E's COVID-19 Vaccine Candidate
Dynavax Technologies (DVAX) announced a commercial supply agreement with Biological E. Limited for its CpG 1018 adjuvant, aimed at enhancing BE's COVID-19 vaccine candidate, CORBEVAX™. The agreement extends through 2022, covering doses manufactured under prior funding from the Coalition for Epidemic Preparedness Innovations (CEPI). In June 2021, India's Ministry of Health secured 300 million doses of CORBEVAX™. Ryan Spencer, CEO of Dynavax, expressed pride in the collaboration, while BE's Managing Director emphasized the vaccine's potential in combating the pandemic.
- Commercial supply agreement with Biological E. Limited for CpG 1018 adjuvant, enhancing vaccine development.
- Access to 300 million doses of CORBEVAX™ secured by the Indian government, indicating strong market potential.
- Collaboration may lead to vital contributions in the fight against COVID-19.
- Dependence on pending regulatory approvals in India for product launch of CORBEVAX™.
- Risks and uncertainties inherent in vaccine development as highlighted in the forward-looking statements.
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 |
vijay.kammari@biologicale.com | |
510-665-7264 | +91 83740 77433 |
Derek Cole, President |
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SOURCE Dynavax Technologies
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