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     138  0 Kommentare Bavarian Nordic Announces that Janssen has Received Positive CHMP Opinion for its Investigational Preventative Ebola Vaccine Regimen

    COPENHAGEN, Denmark, May 29, 2020 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that its strategic partner Janssen Pharmaceutical Companies of Johnson & Johnson has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its investigational Ebola vaccine regimen for the prevention of the Ebola Virus Disease caused by the Zaire ebolavirus species.

    Two Marketing Authorisation Applications (MAAs) were submitted to the EMA in support of the vaccines in the two-dose regimen, which includes Ad26.ZEBOV as the first dose, based on Janssen’s proprietary AdVac viral vector technology, and MVA-BN Filo as the second dose, based on Bavarian Nordic’s MVA-BN technology, administered approximately eight weeks later. The goal of this two-dose approach is to induce long-term immunity against Ebola Virus Disease.

    The regimen is specifically designed to support preventative vaccination in countries that are at risk of Ebola outbreaks, as well as for other at-risk groups such as healthcare workers, BSL4 lab workers, military deployed from other countries, airport staff and visitors to high-risk countries. Janssen is collaborating with the World Health Organization on vaccine pre-qualification to broaden access of its investigational Ebola vaccine regimen to those most in need and enable registration in African countries; European Commission (EC) approval of this regimen may help accelerate this process.

    “The positive opinion issued by CHMP for the Ebola vaccine regimen brings us closer to the second European approval of a product based on our MVA-BN platform, validating a broader usage of the technology in the development of novel vaccines to address unmet medical needs,” said Paul Chaplin, President and CEO of Bavarian Nordic. “We congratulate Janssen on this milestone and applaud their accelerated efforts to bring forward this Ebola vaccine to help protect people at risk of Ebola and prevent future outbreaks.”

    Pending the final approval by the European Commission of the MVA-BN Filo vaccine, Bavarian Nordic would be eligible to receive a milestone payment of USD 10 million under the license agreement with Janssen.

    Background
    Bavarian Nordic and Janssen entered an agreement in 2014, under which MVA-BN Filo was licensed to Janssen as part of their commitment to developing an Ebola vaccine regimen. Under the agreement, Bavarian Nordic also manufactured a significant amount of vaccines.

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    Bavarian Nordic Announces that Janssen has Received Positive CHMP Opinion for its Investigational Preventative Ebola Vaccine Regimen COPENHAGEN, Denmark, May 29, 2020 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that its strategic partner Janssen Pharmaceutical Companies of Johnson & Johnson has received a positive opinion from the Committee for Medicinal …

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