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VBI Vaccines Announces Filing of New Drug Submission for 3-Antigen Hepatitis B Vaccine to Health Canada
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Rhea-AI Summary
VBI Vaccines Inc. (NASDAQ: VBIV) filed a New Drug Submission to Health Canada for its 3-antigen hepatitis B vaccine, aiming for approval in Canada. This vaccine targets all hepatitis B virus subtypes and is already approved in the U.S. as PreHevbrio™. The CEO, Jeff Baxter, emphasized the commitment to collaboration with Health Canada for review. Hepatitis B poses a significant global health risk, affecting over 290 million people. The vaccine's unique formulation is expected to enhance treatment options for adults at risk of hepatitis B infection.
Positive
Filing of New Drug Submission for 3-antigen hepatitis B vaccine candidate in Canada could expand market access.
The vaccine is already approved in the U.S., indicating a level of regulatory credibility.
Negative
VBI's vaccine is not yet approved in Canada or Europe, delaying potential revenue.
Risks associated with regulatory approval process may impact future financial performance.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the filing of a New Drug Submission (NDS) to Health Canada for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate, seeking approval in Canada for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults.
“This regulatory filing for approval in Canada is another milestone in our effort to expand access to our 3-antigen HBV vaccine candidate in more countries,” said Jeff Baxter, VBI’s President & CEO. “We are committed to working collaboratively with Health Canada throughout their review of this submission, as we believe our vaccine candidate has the potential to be a meaningful new tool for healthcare providers in the fight against adult hepatitis B.”
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.
About VBI’s 3-Antigen Hepatitis B Vaccine
VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use in the United States under the name PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], and in Israel under the name Sci-B-Vac®. This vaccine candidate is not yet approved in Canada or Europe, where the regulatory submissions are still under review. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprised the basis for the regulatory submissions in the U.S., Europe, and Canada.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
