Business Wire

VBI Vaccines Announces UK MHRA Marketing Authorisation for PreHevbri™, a 3-Antigen Adult Hepatitis B Vaccine

Share

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for PreHevbri™ [Hepatitis B vaccine (recombinant, adsorbed)] for active immunisation against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

UK marketing authorisation follows the European Commission’s (EC) centralized marketing authorisation received in April 2022, and was conducted as part of the EC Decision Reliance Procedure (ECDRP). VBI expects to make PreHevbri available in the UK in early 2023.

“We are pleased to announce this latest regulatory approval of PreHevbri, our third in the span of six months, and another significant milestone in our efforts to broaden access to our differentiated 3-antigen vaccine,” said Jeff Baxter, VBI’s President and CEO. “Based upon the safety and immunogenicity profiles observed in the PROTECT and CONSTANT pivotal Phase 3 studies, data from which built the foundation of our FDA, EMA, and now UK MHRA approvals, we continue to believe PreHevbri will be a meaningful new intervention in the fight against 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 PreHevbri™

VBI’s hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the European Union/European Economic Area, the United Kingdom, the United States, and Israel. The brand names for this vaccine are: PreHevbri™ (EU/EEA/UK), PreHevbrio™ (US), and Sci-B-Vac® (Israel).

Full European Summary of Product Characteristics for PreHevbri are available from the EMA website at www.ema.europa.eu and from the UK MHRA’s website at products.mhra.gov.uk.

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

About VBI Vaccines Inc.

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. For more information, visit www.vbivaccines.com.

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/PreHevbri; 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/PreHevbri; 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 7, 2022, and filed with the Canadian security authorities at sedar.com on March 7, 2022, 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Positive Results of EfficAPSI Real-World Study Confirm Significant Benefit of Sublingual Liquid AIT Treatment on the Onset and Worsening of Asthma in Patients With Allergic Rhinitis2.7.2022 16:08:00 EEST | Press release

Stallergenes Greer, a global healthcare company specialising in allergen immunotherapy (AIT), today announced positive data from its EfficAPSI real-world study. Presented at the 2022 European Academy of Allergy and Clinical Immunology (EAACI) congress in Prague (Czech Republic), the real-world study confirmed significant benefit of sublingual liquid allergen immunotherapy treatment (AIT) on the onset and worsening of asthma in patients with allergic rhinitis. The retrospective longitudinal pharmaco-epidemiological real-world study included over 430,000 patients: more than 100,000 patients with allergic rhinitis with or without asthma treated with sublingual liquid immunotherapy and symptomatic drugs; compared to more than 330,000 patients with allergic rhinitis with or without asthma treated with symptomatic drugs only. The primary objective of the study was the evaluation of the impact of sublingual liquid AIT on the onset and worsening of asthma in patients with allergic rhinitis. St

Boyd Acquires Sensata’s Thermal Test and Controls Business1.7.2022 18:29:00 EEST | Press release

Boyd, a world-leading innovator of technologies in engineered materials and thermal management, announced it acquired Sensata’s Thermal Test and Controls Business (NYSE:ST). This business specializes in the design and manufacturing of advanced thermal control systems, adapters, and sockets critical to the thermal test process for high-end logic and memory semiconductors. With a long history of serving leading global semiconductor companies, the addition complements Boyd’s existing thermal business, which includes air and liquid cooled thermal management technologies. Boyd designs and manufactures complex thermal solutions for high-performance semiconductors used in applications such as 5G, hyperscale data center, eMobility, and artificial intelligence. With this acquisition, Boyd expands its offering to current semiconductor customers by adding advanced controls and thermal test systems essential to the production of high-end memory and logic devices. “This acquisition is a natural fit

IFF Completed Divestiture of Microbial Control Business1.7.2022 16:45:00 EEST | Press release

IFF (NYSE:IFF) today announced that it has successfully completed the previously announced divestiture of its Microbial Control business unit to LANXESS. Welcome to IFF At IFF (NYSE: IFF), an industry leader in food, beverage, health, biosciences and scent, science and creativity meet to create essential solutions for a better world – from global icons to unexpected innovations and experiences. With the beauty of art and the precision of science, we are an international collective of thinkers who partners with customers to bring scents, tastes, experiences, ingredients and solutions for products the world craves. Together, we will do more good for people and planet. Learn more at iff.com, Twitter, Facebook, Instagram, and LinkedIn. © 2022 by International Flavors & Fragrances Inc. IFF is a Registered Trademark. All Rights Reserved. View source version on businesswire.com: https://www.businesswire.com/news/home/20220630005790/en/ Contact information Michael DeVeau Chief Investor Relatio

Digi International Unveils Digi XBee LR Module for LoRaWAN Connectivity for IoT Deployments1.7.2022 16:00:00 EEST | Press release

Digi International ®, (NASDAQ: DGII), a leading global provider of Internet of Things (IoT) connectivity products, solutions, and services, today unveiled the Digi XBee® LR, the first XBee-class pre-integrated and pre-certified wireless communication module for sensors and end-nodes using LoRaWAN. Coupled with the rich connectivity, device and gateway management capabilities of Digi X-ON™—its Low-Power Wide Area (LPWA) IoT data cloud platform—Digi provides a complete IoT solution with automated provisioning and deployment to help enterprises achieve significant ROI and faster market access. The Digi XBee LR module brings a new connectivity option to one of the most widely adopted wireless IoT module footprints, with more than 20 million devices deployed. This fully developed, tested, and certified module gives OEMs the freedom to create innovative public- or private-cloud solutions for organizations in agriculture, energy, logistics, manufacturing, utilities, and other sectors. These a

Juniper Networks Announces Cloud Metro Innovation to Drive Sustainable Business Growth for Service Providers1.7.2022 15:35:00 EEST | Press release

Juniper Networks (NYSE: JNPR), a leader in secure, AI-driven networks, today announced the innovation that will power its vision and strategy for Cloud Metro – a new category of solutions for service providers, optimized for metro transformation and sustainable business growth. Traditional “retro” metro networks are device-centric and are buckling under the extreme scale, agility and experience demands that widespread digital transformation and the advent of 5G services are bringing. Today’s announcement focuses on enabling sustainable business growth, with a series of high-performance networking systems, powered by AI-enabled, cloud-delivered automation, specifically designed to build next generation Cloud Metro infrastructure. These systems will deliver significantly-reduced natural resource consumption capabilities to help sustain the planet, improved tools and simplified working methods to help sustain over-pressured operations teams, along with embedded service assurance and secur

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom