- VBI and Syneos Health partner to prepare for commercial launch of VBI’s 3-antigen hepatitis B vaccine in the U.S., Europe, and Canada, pending regulatory approvals
- Syneos Health selected for their robust and innovative commercialization experience and deep vaccine expertise, including successful partnerships with leading vaccine manufacturers
- The BLA was submitted to FDA (U.S.) on November 30, 2020 and the MAA was submitted to EMA (Europe) on November 20, 2020
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, and Syneos Health (Nasdaq: SYNH), the leading Contract Commercialization Organization (CCO) and the longest-tenured U.S. provider of outsourced sales teams, today announced a partnership for the commercialization of VBI’s 3-antigen prophylactic hepatitis B (HBV) vaccine in the United States, Europe, and Canada, pending regulatory approvals. VBI and Syneos Health have been working together on the pre-launch strategy and activity since the fourth quarter of 2019. The companies have expanded their relationship to build the leadership team and field teams dedicated to VBI and incorporate full service commercialization solutions.
Jeff Baxter, VBI’s President and CEO commented, “We are excited to announce this partnership with Syneos Health, which represents an innovative, flexible, and integrated approach to vaccine commercialization. VBI is committed to addressing significant unmet medical needs and we believe this vaccine could be an important additional public health intervention for healthcare providers as they work to address the increasing disease burden of hepatitis B in the U.S., Europe, and Canada. Over the last year, we have made significant progress on our roadmap to commercialization with Syneos Health and we move into 2021, and beyond, with a clear, joint mission and action plan to do so.”
Michelle Keefe, President, Syneos Health Commercial Solutions, further commented, “This collaboration brings together robust expertise, experience, and networks from two impressive organizations. We believe this full service commercial engagement provides the insights and best-in-class capabilities needed to support a public health-centered launch of VBI’s vaccine. Our focus is on reaching all adults who need safe and effective protection against HBV infection.”
VBI will access Syneos Health’s fully-integrated, outsourced commercial capabilities and proven delivery model to accelerate launch performance. The cross-functional Syneos Health team will create and execute a comprehensive commercialization strategy including market research, communications, field teams, and operations across Medical Affairs, Market Access, and Sales and Marketing. The commercial program will be powered by Syneos Health’s KineticTM omnichannel capability, aimed at ensuring the right messages reach the right stakeholders at the right time, to drive product adoption and uptake. Syneos Health also brings a demonstrated track record of successfully commercializing vaccines in the North American and European markets with more launches, sales team creations, and recruiting experience than any other biopharmaceutical solutions company.
John Dillman will serve as the Syneos Health Commercial Lead for VBI, orchestrating Syneos Health’s vast commercial capabilities to drive brand performance. Mr. Dillman previously spent 17 years at Sanofi Pasteur, the human vaccines business of the Sanofi Group, in a variety of commercial sales and marketing leadership roles. His most recent role was Vice President of Sales, responsible for direction and oversight of the sales force, marketing and sales training, and telesales organization, with full P&L responsibility delivering over $3 billion of sales annually. During his tenure, Mr. Dillman was also responsible for all segment, consumer, and digital marketing activities, and spent three years as the General Manager of VaxServe, a Sanofi Pasteur company and a leading specialty distributor of vaccines.
About VBI’s 3-Antigen Hepatitis B Vaccine
This vaccine is a 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 and commercially-available in Israel, under the name Sci-B-Vac®. In December 2017, VBI initiated 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, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada.
To learn more about VBI’s 3-antigen Hepatitis B vaccine, visit: https://www.vbivaccines.com/sci-b-vac/
VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with: (1) the only 3-antigen hepatitis B vaccine, which is approved for use and commercially available in Israel, under the name Sci-B-Vac®, and recently completed its Phase 3 program in the U.S., Europe, and Canada; and (2) an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI’s enveloped virus-like particle (eVLP) platform technology enables development of eVLPs that closely mimic the target virus to elicit a potent immune response. VBI’s lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and two prophylactic coronavirus vaccine candidates. VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.
Syneos Health (Nasdaq: SYNH) is the only fully integrated biopharmaceutical solutions organization. Our Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. We bring together approximately 24,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life®, visit syneoshealth.com.
Director, Corporate Communications & IR
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