Bavarian Nordic Provides 2016 Update

Biodefense and Vaccine Industry NewsBavarian Nordic, a biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases, this week announced interim financial results for the first three quarters of 2016.

The company has developed a portfolio of vaccines for infectious diseases, including the non-replicating smallpox vaccine, IMVAMUNE®, which is stockpiled for emergency use by the U.S. and approved in the European Union (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its partner Janssen are developing an Ebola vaccine regimen, which has been fast-tracked, with the backing of worldwide health authorities, and a vaccine for the prevention and treatment of HPV.

Key highlights from 2016 include:

  • In September, Janssen completed a submission for Emergency Use Assessment and Listing for the Ad26.ZEBOV/MVA-BN Filo prime-boost Ebola vaccine regimen to the World Health Organization
  • In October, the first Phase 2 clinical trial of Respiratory Syncytial Virus (RSV) Vaccine Candidate MVA-BN RSV was initiated. The study will help to identify the optimal dose and schedule for a subsequent Phase 2b field efficacy study planned for initiation in 2017
  • In September, Phase 1 results for the MVA-BN RSV vaccine were presented at the 10th International Respiratory Syncytial Virus Symposium
  • In September, Christopher Heery, M.D. was appointed Chief Medical Officer of Bavarian Nordic with immediate effect
  • In August, Bavarian Nordic entered a drug supply agreement with Bristol-Myers Squibb, providing OPDIVO for the upcoming clinical trial of cancer immunotherapy candidate CV301 in non-small cell lung cancer.

Revenue for the nine-month period ending September 30, 2016 was DKK 591 million, of which DKK 452 million was recognized in the third quarter. This is in line with the Company’s expectations, as the majority of revenue relates to production of IMVAMUNE bulk drug substance produced for the U.S. Government, which primarily occurs in the second half of 2016. Thus approximately 40% of the year’s revenue is expected to be recognized in the last quarter of 2016.

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