Bavarian Nordic Announces European Marketing Authorization for Ebola Vaccine
COPENHAGEN, Denmark, July 1, 2020 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that the European Commission has granted marketing authorization for MVABEA® (MVA-BN Filo) together with ZABDENO® (Ad26.ZEBOV), which collectively constitute Janssen’s Ebola vaccine regimen. The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in May 2020. The vaccine regimen is indicated for active immunization for prevention of disease caused by Ebola virus in individuals aged one year and above.
The marketing authorization has been granted to Janssen Vaccines & Prevention B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson who obtained a worldwide license to develop, manufacture and commercialize MVA-BN Filo from Bavarian Nordic in 2014.
The Ebola vaccine regimen is specifically designed to induce long-term immunity against the Ebola virus, in adults and children aged one year and above. As such, it will be used to support preventive vaccination in countries most at risk of outbreaks, as well as for other at-risk groups such as healthcare workers, biosafety level 4 (BSL4) laboratory workers, military personnel deployed in the affected regions, airport staff and visitors to high-risk countries.
In connection with the approval of MVABEA by the European Commission, Bavarian Nordic will receive a milestone payment of USD 10 million under the license agreement with Janssen. This will not impact the Company’s financial guidance for the full year 2020.
“We are proud to have supported the development of a new Ebola vaccine, which represents the second European approval of a product based on our MVA-BN platform technology,” said Paul Chaplin, President & CEO of Bavarian Nordic. “The urgency remains to ensure we can face future outbreaks with an even stronger preparedness and response. This new vaccine can help combat a serious threat to global health and we are pleased to continue to support Janssen in the manufacturing of Ebola vaccines and in the further work towards regulatory approval beyond the EU.”
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 Ebola vaccine, licensed to Janssen. For more information visit www.bavarian-nordic.com.
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.
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, firstname.lastname@example.org, Tel: +1 781 686 9600
Company Announcement no. 39 / 2020