BAVA Bavarian Nordic A/S

Bavarian Nordic to Manufacture Additional Ebola Vaccines for Janssen

Bavarian Nordic to Manufacture Additional Ebola Vaccines for Janssen

COPENHAGEN, Denmark, June 12, 2020 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that the Company has entered into a new supply contract with Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson valued at USD 13.9 million.

Under the contract, Bavarian Nordic will manufacture and deliver bulk drug substance of its MVA-BN® Filo vaccine, which Janssen has licensed as part of its Ebola vaccine regimen.

While manufacturing of the vaccines will be initiated in 2020, supply and invoicing will not occur until 2021. Hence the contract does not impact the Company’s financial guidance for the full year 2020.

 “We are pleased to continue our strong collaboration with Janssen,” said Paul Chaplin, President & CEO of Bavarian Nordic. “Ebola remains a significant threat to global health security, and the supply of vaccines for local citizens, healthcare workers and others who are being deployed in risk areas is crucial to prevent future outbreaks.”

The contract builds on Bavarian Nordic’s existing collaboration with Janssen, under which Bavarian Nordic has previously manufactured more than 2 million doses of MVA-BN Filo.

In May 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion, recommending approval of the Ebola vaccine regimen which consists of two components, Ad26.ZEBOV, which is given first, and MVA-BN Filo which is administered approximately eight weeks later as a second vaccination. The final approval is pending decision by the European Commission.

About Bavarian Nordic

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacture and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Strategic National Stockpile of a non-replicating smallpox vaccine, which has been approved by the FDA under the trade name JYNNEOS®, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe under the trade name IMVANEX® and in Canada under the trade name IMVAMUNE®. Our commercial product portfolio furthermore contains market-leading vaccines Rabipur®/RabAvert® against rabies and Encepur® against tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an investigational Ebola vaccine, licensed to Janssen. For more information visit .

Forward-looking statements

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.

Contacts

Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel:

US: Graham Morrell, Paddock Circle Advisors, , Tel:

Company Announcement no. 37 / 2020

 

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12/06/2020

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