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The contract provides funds to validate the new freeze-driedmanufacturing process and the associated pre-clinical and clinical studies tosupport the advanced development of a freeze-dried version of IMVAMUNE(R).The base year funding represents 33% of the total contract value, followed byfour additional years of optional funding, which are triggered by thecompletion of pre-determined technical milestones. These freeze-drieddevelopment activities will be performed in parallel to the licensureactivities of the current liquid-frozen IMVAMUNE(R) formulation under theRFP-3 contract.
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The contract does not affect the company's expectations for the 2009 fullyear results.
With this contract, the US Government has to-date awarded contracts toBavarian Nordic for the development and procurement of IMVAMUNE(R) worth morethan USD 680 million. Under the ongoing RFP 3 contract, Bavarian Nordic willdeliver 20 million doses of IMVAMUNE(R) in the current liquid-frozenformulation. Once the contract option for an additional 60 million doses isexpectedly exercised, these vaccines will be delivered in the liquid-frozenformulation as well. Thus, the new contract will have no influence on theongoing contracts, but represents an additional business opportunity and willexpectedly constitute the gateway towards securing additional contracts forthis new freeze-dried version with the US Government and outside the US aswell.
A freeze-dried formulation of IMVAMUNE(R) offers various new advantagesin terms of a potential increased shelf-life compared to the currentliquid-frozen formulation. Additionally, this would help overcome thechallenges with the cold-chain logistics and storage.
Anders Hedegaard, President & CEO of Bavarian Nordic said: "We areexcited about receiving yet another contract from the US Government insupport for the development of an advanced freeze-dried version of ourIMVAMUNE(R) smallpox vaccine. It clearly demonstrates the continuedcommitment from the US Government to support the development of advancedmedical countermeasures and it strengthens our confidence, that the option toprocure up to an additional 60 million doses of IMVAMUNE(R) under the ongoingRFP-3 contract will be exercised."
Forward-looking statements
This announcement includes "forward-looking statements" that involverisks, uncertainties and other factors, many of which are outside of ourcontrol that could cause actual results to differ materially from the resultsdiscussed in the forward-looking statements. Forward-looking statementsinclude statements concerning our plans, objectives, goals, future events,performance and/or other information that is not historical information. Weundertake no obligation to publicly update or revise forward-lookingstatements to reflect subsequent events or circumstances after the date made,except as required by law.
About Bavarian Nordic
Bavarian Nordic A/S is a leading industrial biotechnology companydeveloping and producing novel vaccines for the treatment and prevention oflife-threatening diseases with a large unmet medical need. The company'spipeline is focused in the three areas; biodefence, cancer and infectiousdiseases, and includes seven development programmes. Two programmes are readyfor Phase III: IMVAMUNE(R), a third-generation smallpox vaccine is beingdeveloped under a contract with the US government, and PROSTVAC(TM), atherapeutic vaccine for advanced prostate cancer is being developed under acollaboration agreement with the National Cancer Institute.
Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.
For more information please visit http://www.bavarian-nordic.com
SOURCE Bavarian Nordic A/S
