updated 11/9/2010 8:46:31 AM ET 2010-11-09T13:46:31

KVISTGAARD, Denmark, Nov. 9, 2010 (GLOBE NEWSWIRE) -- Bavarian Nordic (Copenhagen:BAVA) published today its 2010 third quarterly results. The full report is available on the company's website: www.bavarian-nordic.com.

In the first nine months of 2010 Bavarian Nordic generated revenue of DKK 219 million and recorded a loss before tax of DKK 386 million. Revenue is primarily derived from the deliveries of IMVAMUNE(R) smallpox vaccine to the U.S. Strategic National Stockpile. As of 30 September 2010 the Group's cash preparedness was DKK 400 million. The company maintains its full-year expectations with revenues in the level of DKK 325 million, and a pre-tax loss in the level of DKK 450 million. The cash preparedness at year-end is expected to be in the level of DKK 250 million.

Commenting on the interim report Anders Hedegaard, President & CEO of Bavarian Nordic said: "Bavarian Nordic's development in third quarter progressed as planned. The deliveries of IMVAMUNE(R) to the U.S. Strategic National Stockpile continued and preliminary test results from the production indicate that our efforts to solve the technical issues were successful. We also completed a number of milestones in the development of a freeze-dried version of IMVAMUNE(R) which triggered the next option in the contract and furthermore we received funding from the US to advance our research in Ebola and Marburg viruses, which in time may complement our biodefence portfolio. In the cancer vaccine business, we made important progress in the PROSTVAC(TM) programme with thesubmission to the SPA process with the FDA, with expected feedback in fourth quarter 2010."

Highlights from the period

  • In September, Bavarian Nordic announced the reorganization of the company's primary business areas into two divisions; Cancer Vaccines and Infectious Diseases.
  • As planned, Bavarian Nordic submitted in August the PROSTVAC(TM) Phase III clinical trial protocol to the Special Protocol Assessment (SPA) process with the FDA.
  • The last milestone payment under the BARDA RFP-3 contract was received earlier than previously expected after completion of certain important milestones related to the development and deliveries of IMVAMUNE(R).

Important events after the period

  • Bavarian Nordic is currently in advanced discussions and due diligence with a number of pharmaceutical companies, including some 
  •  of the world's largest, on the Phase III development and commercialisation of PROSTVAC(TM).
  • After the successful implementation of a number of corrective actions, the production of IMVAMUNE(R) smallpox vaccine has now resumed with 2 batches per week. Although all these batches are still undergoing the standard release tests to ensure the quality of the product, all batches have currently passed the specifications. The plans to further increase the output to 3 batches per week in the beginning of 2011 and eventually 4 batches per week remain ontrack.
  • To date, more than 1.7 million doses of IMVAMUNE(R) have been delivered to the U.S. Strategic National Stockpile under the contract with BARDA to deliver 20 million doses. Two million doses are expected to be delivered in 2010 with the remaining 18 million doses expected to be delivered in the period 2011-2013. The exact delivery schedule is expected to be determined during 2011.
  • Upon the successful completion of a number of development milestones, the next option under the contract with BARDA to deliver a freeze-dried version of IMVAMUNE(R) was triggered in October. The option provides next year's funding under the contract, totalling approx. USD 14 million.
  • The company has submitted the final study report for a large Phase II study of IMVAMUNE(R) in patients diagnosed with atopic dermatitis 
  • (AD) to the FDA. Patients with AD are currently  contraindicated to the existing licensed smallpox vaccine and these data could potentially expand the use of IMVAMUNE(R) in the US. The US government have earlier published the need for a safer smallpox vaccine to protect 66 million people in the US, including 30 million people diagnosed with AD.
  • In October, the company received funding from the U.S. National Institutes of Health (NIH) to advance its early research in the use of the MVA-BN(R) technology in the prevention of filoviruses (Ebola and Marburg virus).

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.

About Bavarian Nordic

Bavarian Nordic is a leading industrial 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 clinical pipeline targets cancer and infectious diseases, and includes seven development programmes. Two programmes under preparation for Phase III: PROSTVAC(TM), a therapeutic vaccine for advanced prostate cancer is being developed under a collaboration agreement with the National Cancer Institute, and IMVAMUNE(R), a third-generation smallpox vaccine is being developed under a contract with the US government.

Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.

For more information please visit www.bavarian-nordic.com

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