Bavarian Nordic Announces Execution of Option on Freeze-Dried IMVAMUNE
- Option results in $21.9M payment from U.S. Government
KVISTGAARD, Denmark, April 22, 2014 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that the Biomedical Advanced Research and Development Authority (BARDA) has exercised an option at a value of USD 21.9 million under the existing development contract for freeze-dried IMVAMUNE smallpox vaccine. This will fund the transfer of the already validated manufacturing process to a commercial manufacturing line with a larger capacity.
Under the freeze-dried contract, which was awarded in 2009, the Company has validated the freeze-dried manufacturing process and shown the freeze-dried formulation to induce an equivalent immune response and efficacy as the current liquid frozen formulation in numerous animal models.
The execution of this option follows the completion of enrollment of 680 healthy subjects in a Phase 2 study designed to meet the clinical requirements for emergency use in the U.S. of the freeze-dried formulation of the vaccine, which would enable the product to be stockpiled. A freeze-dried formulation is expected to reduce life cycle management costs based on a longer shelf life. Data from the study are expected to be submitted to the FDA in 2015, potentially supporting the production and supply of freeze-dried IMVAMUNE in 2016. Procurement would need to be conducted through a new contract, which the Company expects to initiate dialogue with the U.S. Government in 2014.
The exercise of the option does not change the Company’s financial guidance for 2014.
Chairman of the Board
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
About Bavarian Nordic
Bavarian Nordic is an international biotechnology company developing and manufacturing novel cancer immunotherapies and vaccines for infectious diseases. Lead product candidates are PROSTVAC®, an immunotherapy product candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 clinical trial and IMVAMUNE, a non-replicating smallpox vaccine candidate in Phase 3 development, which is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. The vaccine is approved in Canada under the trade name IMVAMUNE and in the European Union under the trade name IMVANEX®.
Bavarian Nordic's shares are listed on NASDAQ OMX Copenhagen under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The company has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol BVNRY.
For more information, visit www.bavarian-nordic.com.
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.
Company Announcement no. 5 / 2014