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Bavarian Nordic Receives USD 25 Million Milestone Payment After Submission of Important IMVAMUNE(R) Data to The U.S. Health Authorities
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KVISTGARD, Denmark, November 19 /PRNewswire-FirstCall/ -- Bavarian Nordichas invoiced the U.S. authorities for another milestone payment of USD 25million as allowed under the RFP-3 contract to manufacture and deliver 20million doses of the company's IMVAMUNE(R) smallpox vaccine. This milestonepayment was triggered by the recent submission of a clinical safety reportfrom a large Phase II study with IMVAMUNE(R) in HIV infected subjects, whichis part of the regulatory package that will be used to potentially supportthe use of IMVAMUNE(R) in a declared emergency. With this, Bavarian Nordic isan important step closer to fulfilling the conditions for initiating deliveryof IMVAMUNE(R) in 2009.
The income will be recognised as revenue in the financial statements for2008.
With this payment, Bavarian Nordic has so far invoiced a total of USD 125million in advance- and milestone payments under the RFP-3 contract, of whichUSD 50 million has not yet been recognised in the income statement.
This announcement does not change Bavarian Nordic's previously announcedfinancial guidance for 2008.
Anders Hedegaard, President & CEO of Bavarian Nordic, said: "Since theaward of the RFP-3 we have successfully met all agreed objectives in thecontract with the U.S. Department of Health and Human Services and we findthis very satisfactory. The submission of these clinical data concludes thedata package that may support the use of IMVAMUNE(R) in a declared emergencyand marks an important event for the company this year. This submission ispart of the company's plan to support the delivery of IMVAMUNE(R) which isplanned to start during 2009".
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'sbusiness strategy is focused in three areas: biodefence, cancer andinfectious diseases. Bavarian Nordic's proprietary and patented technologyMVA-BN(R) is one of the world's safest, multivalent vaccine vectors. BavarianNordic has ongoing contracts with the U.S. government for the late-stagedevelopment and procurement of the company's third-generation smallpoxvaccine, IMVAMUNE(R).
Bavarian Nordic is listed on the NASDAQ OMX Copenhagen under the symbolBAVA.
For more information please visit http://www.bavarian-nordic.com
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.
SOURCE Bavarian Nordic A/S
With this payment, Bavarian Nordic has so far invoiced a total of USD 125million in advance- and milestone payments under the RFP-3 contract, of whichUSD 50 million has not yet been recognised in the income statement.
This announcement does not change Bavarian Nordic's previously announcedfinancial guidance for 2008.
Anders Hedegaard, President & CEO of Bavarian Nordic, said: "Since theaward of the RFP-3 we have successfully met all agreed objectives in thecontract with the U.S. Department of Health and Human Services and we findthis very satisfactory. The submission of these clinical data concludes thedata package that may support the use of IMVAMUNE(R) in a declared emergencyand marks an important event for the company this year. This submission ispart of the company's plan to support the delivery of IMVAMUNE(R) which isplanned to start during 2009".
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'sbusiness strategy is focused in three areas: biodefence, cancer andinfectious diseases. Bavarian Nordic's proprietary and patented technologyMVA-BN(R) is one of the world's safest, multivalent vaccine vectors. BavarianNordic has ongoing contracts with the U.S. government for the late-stagedevelopment and procurement of the company's third-generation smallpoxvaccine, IMVAMUNE(R).
Bavarian Nordic is listed on the NASDAQ OMX Copenhagen under the symbolBAVA.
For more information please visit http://www.bavarian-nordic.com
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.
SOURCE Bavarian Nordic A/S
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