COVID-19 Vaccine Developed by Biological E Using Dynavax's CpG 1018 Adjuvant Receives India DCGI Approval for Emergency Use
Dynavax Technologies Corporation (DVAX) announced that Biological E's COVID-19 vaccine, CORBEVAX™, received emergency use approval from India's Drugs Controller General. This vaccine uses Dynavax's CpG 1018® adjuvant. The companies have a commercial supply agreement for 300 million doses, bolstering Dynavax's supply capabilities for 2022 and beyond. The CpG 1018 adjuvant is proven to enhance vaccine immune response and is included in multiple vaccines, contributing over $197 million in revenue in 2021.
- CORBEVAX™ vaccine approval enhances Dynavax's market position.
- Secured contract for supplying 300 million doses of CpG 1018 adjuvant.
- Generated over $197 million in revenue in 2021 from adjuvant sales.
- Dependence on Biological E for future revenue generation.
- Risks associated with market acceptance and manufacturing capacity of the vaccine.
EMERYVILLE, Calif., Dec. 28, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) a biopharmaceutical company focused on developing and commercializing vaccines, today announced that Biological E reported that CORBEVAX™, their COVID-19 vaccine which contains Dynavax's CpG 1018® adjuvant, received approval for emergency use from the Drugs Controller General of India (DCGI). Dynavax and Biological E previously announced the execution of a commercial supply agreement (CSA) for Dynavax to supply its CpG 1018 adjuvant for use in Biological E's CORBEVAX.
"We congratulate Biological E for achieving this initial approval of their COVID-19 vaccine," commented Ryan Spencer, Chief Executive Officer of Dynavax. "We have secured the capacity to deliver on our commitment to supply CpG 1018 adjuvant to Biological E to meet their needs for their existing contract with the Indian Government for 300 million doses, as well as any additional adjuvant required to fulfill future demand in 2022 and beyond. We are proud of the impact we are having on the pandemic by supporting equitable access to quality vaccines across the globe."
Dynavax developed its CpG 1018 adjuvant to provide an increased vaccine immune response with an improved tolerability profile. The adjuvant has a well-established safety and efficacy profile as demonstrated in global clinical trials and commercial use. CpG 1018 adjuvant is contained in Dynavax's U.S. FDA- and European Commission-approved adult hepatitis B vaccine, as well as in two COVID-19 vaccines that have received regulatory approval or authorization.
CpG 1018 adjuvant provides opportunities for Dynavax as a vaccine developer and as a commercial supplier of adjuvant. CpG 1018 adjuvant is currently being used in the development of vaccines using different technologies across multiple indications including COVID-19, Tdap, plague, and influenza. For COVID-19 specifically, Dynavax is supporting vaccine development by providing CpG 1018 adjuvant through CSAs supporting four geographically and technologically diversified vaccines, which generated over
About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed CpG 1018 adjuvant to provide an enhanced vaccine immune response, which has been demonstrated in HEPLISAV-B and in multiple COVID-19 vaccine candidates. CpG 1018 adjuvant provides a well-developed technology and a significant safety database, supporting development and large-scale manufacturing of a COVID-19 vaccine.
About Dynavax
Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. 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, plague, Tdap, seasonal influenza and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.
Forward-Looking Statements
This press release contains "forward-looking statements," including statements regarding expected results for an ongoing contractual relationship and expected business results. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "will," "would" and similar expressions, or they may use future dates. Forward-looking statements in this document include, without limitation, statements regarding our expectations as to outcomes relating to ongoing collaborations and contractual relationships, the timing of product launches, capacity scale up and product demand, our ability to support Biological E's vaccine development program and our related financial performance. These forward-looking statements are subject to assumptions, risks and uncertainties that may change at any time, and readers are therefore cautioned that actual results could differ materially from those expressed in any forward-looking statements. Factors that could cause actual results to differ include, among other things: risks and uncertainties associated with market acceptance of the vaccine provided by Biological E; whether sufficient quantities of CpG 1018 will be able to be manufactured; whether or how much COVAX or other commercial customers purchase from Biological E; and other risks and uncertainties discussed in the Company's filings with the SEC, including the "Risk Factors" sections of the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. The Company undertakes no obligation to update any forward-looking statements as a result of new information, future developments or otherwise, except as expressly required by law. All forward-looking statements in this document are qualified in their entirety by this cautionary statement.
Contacts:
Nicole Arndt, Investor Relations
narndt@dynavax.com
510-665-7264
Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
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SOURCE Dynavax Technologies
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