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Bavarian Nordic Announces Exercise of Clinical Option by the US Government under Contract for Freeze-dried IMVAMUNE Smallpox Vaccine | ||
By: Nasdaq / GlobeNewswire - 21 Nov 2017 | Back to overview list |
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COPENHAGEN, Denmark, November 21, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that the Biomedical Advanced Research and Development Authority (BARDA) have exercised an option under the recently announced contract for freeze-dried IMVAMUNE ® . The option, which represents approximately USD 37 million of the total contract of up to USD 539 million, will cover development costs associated with the Phase 3 study required for the eventual approval of the freeze-dried product. "We are very excited about receiving this notification and the speed by which this option was awarded, which is yet another example of the excellent partnership we have with BARDA and the US Government, and a highly encouraging signal for the future of freeze-dried IMVAMUNE," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. As previously confirmed with regulators, this study will be a lot consistency study in healthy volunteers across several consecutive production lots of freeze-dried IMVAMUNE, similar to the prior completed Phase 3 study of liquid-frozen IMVAMUNE. The requirement of only one Phase 3 study was confirmed at an End of Phase 2 meeting with the regulatory authorities, following a prior Phase 2 study showing bioequivalence between the freeze-dried and liquid-frozen formulations of IMVAMUNE. The contents of this announcement do not affect the Company's expectations for the financial results for 2017. The contract option is expected to be revenue recognized between 2018 and 2022.
Federal funding acknowledgements
About Bavarian Nordic
Forward-looking statements
Contacts
Seth Lewis
Company Announcement no. 31 / 2017
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Bavarian Nordic A/S via GlobeNewswire
HUG#2150474
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