Bavarian Nordic Enters Agreement with Switzerland on the Supply of Smallpox and Monkeypox Vaccine

Bavarian Nordic A/S
Bavarian Nordic A/S
  • Switzerland has ordered 100,000 doses of smallpox and monkeypox vaccine with deliveries starting imminently

  • Bavarian Nordic will seek regulatory approval of the vaccine with Swissmedic, the Swiss Agency for Therapeutic Products

COPENHAGEN, Denmark, October 14, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Swiss Federal Office of Public Health and the Swiss Armed Forces have jointly ordered 100,000 doses of MVA-BN smallpox and monkeypox vaccine. First deliveries will start imminently, and final deliveries will occur in early 2023.

As part of the agreement, Bavarian Nordic will submit an application to Swissmedic within three months to support a potential marketing authorization of the vaccine against smallpox and monkeypox in 2023.

Given the magnitude of the order and the delivery schedule this will not impact the financial guidance for 2022.

Paul Chaplin, President and CEO of Bavarian Nordic said: “As the epicenter of the outbreak, Europe has seen a wide spread of monkeypox as well as a high number of cases in many countries. Thankfully, the case numbers are now going down, but efforts are still required to end the outbreak and hopefully preventing the disease becoming endemic in the region. We are therefore pleased to enter this agreement with the Swiss authorities, complementing the efforts by the EU Commission to provide access to the vaccine for at-risk populations across the entire region.”

About the smallpox and monkeypox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic (marketed as IMVANEX® in Europe, JYNNEOS® in the U.S. and IMVAMUNE® in Canada) is a non-replicating smallpox vaccine developed in collaboration with the U.S. government to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines. In addition to smallpox, the U.S. Food and Drug Administration, Health Canada and the European Commission have also approved the vaccine for use against monkeypox as the only vaccine having obtained this to-date.

Bavarian Nordic has ongoing supply contracts with USA and Canada and has delivered the vaccine to a number of undisclosed countries globally as part of their national biological preparedness. During the ongoing 2022 outbreak of monkeypox, Bavarian Nordic has worked with multiple governments and supranational organizations to ensure rapid access to the vaccine in more than 70 countries to-date and is working to expand its manufacturing capacity to fulfil the global demand in the medium- to long term.

About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing 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. Government of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against monkeypox. The vaccine is also approved in Europe and Canada. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and 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 Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine. For more information visit www.bavarian-nordic.com.

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: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600

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