- Collaboration valued up to $36M
- Multivalent vaccine designed to protect humans against Eastern, Venezuelan, and Western equine encephalitis virus
COPENHAGEN, Denmark, March 16, 2018 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today the signing of a new alliance with the United States Department of Defense (DoD) for the development of a prophylactic vaccine against the equine encephalitis virus-a rare, but potentially deadly mosquito-borne illness. With funding from the DoD, Bavarian Nordic will utilize its proprietary MVA-BN® platform to develop a vaccine against various strains of the virus, for which there is currently no preventative vaccine treatment available.
An MVA-BN® based candidate vaccine targeting three separate equine encephalitis viruses including Eastern (EEEV), Venezuelan (VEEV), and Western (WEEV) has already demonstrated efficacy against all three viruses in preclinical models. The multi-year collaboration will include further preclinical studies to support clinical development, GMP production and establishment of safety and immunogenicity in humans. Clinical proof of concept data will warrant further development of the MVA-BN® based candidate vaccine with potential follow-on funding towards FDA licensure and production. The vaccine would then be available to the DoD as needed to vaccinate individuals who may be deployed in a region considered at high risk for a particular illness.
The agreement includes total potential considerations of approximately US$36 million. The award of this multi-year contract does not change the Company's financial guidance for 2018.
"We are very proud of this alliance which represents yet another public/private engagement between Bavarian Nordic and the U.S. government, and provides the Department of Defense with the first in what could become a 'library' of safe, clinically validated vaccines that are readily accessible and can be deployed as needed," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. "This type of collaboration further validates our model for preparedness, which could prove useful in the years to come for this, and potentially other rare and tropical diseases."
About Equine Encephalitis Viruses
Eastern, Venezuelan and Western equine encephalitis virus belong to the family alphavirus, and are transmitted through mosquitos, as well as birds and some mammals. While the viruses vary in infection rates and severity of disease, all three pathogens are associated with risks of flu-like symptoms, potential central nervous disorders, and death. All three viruses are also considered as potential biological threats, having been investigated as potential biological weapons at various times in the past century.
Federal funding acknowledgment
This project will be funded in whole or in part with federal funds under an Other Transaction Authority agreement with U.S. Army Contracting Command-New Jersey through the Medical CBRN Defense Consortium, contract MCDC-17-04-001/2018-315
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative and safe therapies against cancer and infectious diseases. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates intended to improve the health and quality of life for children and adults. We supply our IMVAMUNE® non-replicating smallpox vaccine to the U.S. Strategic National Stockpile and other government stockpiles. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Registration studies are currently underway in the U.S. In addition to our long-standing collaboration with the U.S. government on the development of IMVAMUNE® and other medical countermeasures, our infectious disease pipeline comprises a proprietary RSV program as well as vaccine candidates for Ebola, HPV, HBV and HIV, which are developed through a strategic partnership with Janssen. Additionally, in collaboration with the National Cancer Institute, we have developed a portfolio of active cancer immunotherapies, designed to alter the disease course by eliciting a robust and broad anti-cancer immune response while maintaining a favorable risk-benefit profile. Through multiple industry collaborations, we seek to explore the potential synergies of combining our immunotherapies with other immune-modulating agents, e.g. checkpoint inhibitors.
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Vice President Investor Relations (US)
Tel: +1 978 341 5271
Company Announcement no. 09 / 2018