KVISTGARD, Denmark, November 6 Bavarian Nordichas completed a clinical safety report from a large Phase II study withIMVAMUNE(R) in HIV infected subjects that confirms the excellent safetyprofile of IMVAMUNE(R). Within the next few days the safety report of thisstudy will be submitted to the FDA and this will trigger a USD 25 millionmilestone payment under the RFP-3 contract. The clinical safety reportconstitutes a major part of the data package that will be used to potentiallysupport the use of IMVAMUNE(R) in a declared emergency.
In support of using IMVAMUNE(R) as a smallpox vaccine in individualsotherwise contraindicated to receive conventional vaccinia vaccines, BavarianNordic has performed a large Phase II study in HIV infected subjects with CD4counts between 200 and 750 cells/microl to compare the safety to healthysubjects.
The safety report from this study, which represents an essential part ofthe EUA data package, includes safety data from over 300 HIV infected and 86healthy subjects, all of whom had no history of prior smallpox vaccination.The low number of adverse events confirmed the favourable safety profile ofIMVAMUNE(R) in vaccinia-naive HIV infected subjects with varying degrees ofimmune suppression. Indeed, there was no difference in adverse events betweenthe healthy and HIV infected subjects, even in the most immune compromisedpatients (CD4 counts greater than or equal to 200-350 cells/microl).IMVAMUNE(R) has now been tested in more than 2,200 people in 11 completed oron-going clinical studies, which includes a large proportion (more than 750)of immune-compromised people i.e. HIV infected or diagnosed with AtopicDermatitis (AD) who are excluded from vaccination with traditional smallpoxvaccines.
The complete data set from this trial is expected to be reported in thesecond half of 2009. The final report will include data on immunogenicity aswell as long-term (6-month) safety information and will contain data fromsubjects enrolled in an additional study arm funded by the NIH under RFP-2(HIV infected subjects with a history of previous exposure to a conventionalsmallpox vaccine).
This announcement does not change Bavarian Nordic's previously announcedfinancial guidance for 2008.
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
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