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Bavarian Nordic Receives Additional Order for IMVAMUNE® Smallpox Vaccines from the Canadian Government


November 28, 2012 - London

  • Canadian Government exercises option to replace current IMVAMUNE® stockpile
  • Licensure in Canada pending with anticipated decision in first half 2013
  • Raises full year group financial expectations and year-end cash preparedness

KVISTGAARD, Denmark, November 28, 2012 - Bavarian Nordic A/S (OMX: BAVA) today announced that the Canadian Government, through exercise of an option under an ongoing contract, has ordered 20,000 doses of IMVAMUNE® smallpox vaccine to replace the current stockpile, that was delivered in 2009.

Since 2008, Bavarian Nordic has collaborated with the Canadian Government to address their biological preparedness requirements. The company was initially awarded a contract to supply 20,000 doses of IMVAMUNE® to the Canadian armed forces. Also, the contract provided milestone-based funding for the filing of a New Drug Substance application for IMVAMUNE® for use in the general population. The NDS was filed in 2011 and is currently under review by Health Canada with anticipated decision in the first half of 2013.

Anders Hedegaard, President & CEO commented: "With this order, the Canadian authorities have demonstrated their long-term commitment to secure IMVAMUNE® as part of their biological preparedness in case of an emergency. The anticipated marketing approval of IMVAMUNE® in Canada next year will expand the business opportunity and could represent this first product license for Bavarian Nordic in any country."

Raised financial expectations
Due to the new order and reimbursement of costs related to the licensing of IMVAMUNE® in Canada, the company raises its financial expectations for the year. Revenues are raised from approximately DKK 975 million to approximately DKK 1 billion and the result before tax is improved by DKK 20 million from a loss of approximately DKK 70 million to a loss of approximately DKK 50 million. The cash preparedness at year-end is now expected to be approximately DKK 540 million against previously approximately DKK 525 million, including a credit facility of DKK 120 million.

 

Asger Aamund
Chairman of the Board

 

Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64

About Bavarian Nordic
Bavarian Nordic is a vaccine-focused biotechnology company developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need. The company's pipeline targets cancer and infectious diseases, and includes ten development programs. In oncology, the company's lead program is PROSTVAC®, a therapeutic vaccine candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 trial and is being developed under a collaboration agreement with the National Cancer Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC® has been tested in nearly 600 patients. In infectious diseases, the company's lead program is IMVAMUNE®, a non-replicating smallpox vaccine candidate that is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. 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. 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.

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This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.

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(i) the releases contained herein are protected by copyright and other applicable laws; and
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information contained therein.

Source: Bavarian Nordic A/S via Thomson Reuters ONE

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