Delårstal 20043 mdr.halvår9 mdr.Nettoomsætning109.20000Resultat af primær drift48.70000Resultat før skat52.90000Resultat efter skat og min.37.70000
und dann noch ein bissl was zum Unternehmen:
COPENHAGEN, Denmark, May 11 /PRNewswire/ --
- To The Copenhagen Stock Exchange
Bavarian Nordic announced today positive results in its global development programme of IMVAMUNE(TM) as a safe third-generation MVA smallpox vaccine. Results from the recently-completed Phase ll dose finding trial with IMVAMUNE(TM) in 165 healthy volunteers reconfirmed the strong safety and immunogenicity profile of the vaccine as reported from an earlier Phase I trial.
In this Phase ll trial, IMVAMUNE(TM) was found to have an excellent safety profile at all three dose levels tested. No serious adverse reactions were reported. Of the adverse reactions reported, the majority were mild-to-moderate injection site reactions.
More importantly these adverse events did not result in impairment of daily activities, indicating the superior tolerability of IMVAMUNE(TM) over traditional smallpox vaccines. In similar studies with traditional smallpox vaccines such as DryVax (R) , more than one-third of the subjects were sufficiently ill to miss work, school or recreational activities.
All volunteers who received the highest dose level of IMVAMUNE(TM) exhibited an excellent and rapid immune response, demonstrated by 94.2% sero-conversion after one vaccination and 100% after two vaccinations. Even more noteworthy was the immune response seen in the two low-dose groups. All subjects in these groups sero-converted after having received the full vaccination course. Further follow-up studies to evaluate the persistence of the immune response are planned.
Commenting on this latest development, Peter Wulff, President and CEO of Bavarian Nordic said, "The results of this Phase II study are very exciting and further justify the acceleration of our global clinical development of IMVAMUNE(TM). These results, along with our announcement last week to begin for the first time ever a Phase l trial with IMVAMUNE in atopic dermatitis, represent significant progress in our path to globally register IMVAMUNE(TM) as a safe third-generation smallpox vaccine for the general population, including the immune compromised."
Asger Aamund, Chairman of the Board
About Bavarian Nordic:
Founded in 1994, Bavarian Nordic A/S is a leading biopharmaceutical company in the field of innovative vaccines to prevent and treat infectious diseases. With operations in Denmark and Germany, Bavarian Nordic employs over 100 people and is listed on the Copenhagen Stock Exchange under the trading symbol BAVA.
Bavarian Nordic''s proprietary core technology MVA-BN (R) , is one of the world''s safest, multivalent vaccine vectors and ideally suited for use against various infectious diseases such as smallpox, HIV, Japanese Encephalitis and Dengue Fever. Several MVA-BN (R) -based HIV and smallpox vaccines are in clinical Phase I and Phase II trials.
With respect to smallpox vaccines, Bavarian Nordic has supply and development contracts with the governments of Germany, the U.S.A., and other countries. One of the company''s development agreements includes a three-year contract (awarded in February 2003) with the U.S. Department of Health and Human Services to develop MVA-BN (R) as a safe third-generation smallpox vaccine.
Bavarian Nordic is one of the few companies in the world able to supply the growing demand for smallpox vaccines, particularly safe smallpox vaccines. With the acquisition of a manufacturing facility in Denmark able to produce up to 120 million doses per year and a separate pilot facility in Berlin, Germany, Bavarian Nordic has established its own production capabilities and ensured the supply of its current and future vaccines.
Bavarian Nordic''s partners include Epimmune of the U.S.A., Gerolymatos of Greece, Impfstoffwerk Dessau-Tornau (IDT) of Germany, and Vaccine Solutions of Australia.
For more information please visit www.bavarian-nordic.com
Bavarian Nordic A/S
© PR Newswire
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COPENHAGEN, Denmark, May 5 /PRNewswire/ --
Bavarian Nordic A/S announced today that the U.S. Food and Drug Administration (FDA) has approved the company''s Investigational New Drug Application (IND) for its third-generation smallpox vaccine candidate to enter further clinical trials. Bavarian Nordic will immediately start a Phase l study with IMVAMUNE(TM), its safe third-generation smallpox vaccine, in 60 subjects including persons suffering from atopic dermatitis. This study will be conducted in Europe with the final report expected in 2005.
Persons with atopic dermatitis, more commonly known as eczema, are at risk in suffering potentially severe side effects from first and second generation smallpox vaccines. These persons as well as others in the known high-risk groups (immune compromised, pregnant, young, elderly, etc.) hould not be given these vaccines.
Peter Wulff, President and CEO said, "With this latest IND, we will initiate, for the first time ever, a trial in a significant population of people that cannot safely receive the current smallpox vaccine. While the next phase in the US government''s MVA smallpox vaccine development programme (RFP-2 to be awarded in summer 2004) will require clinical trials in high-risk populations, we already
have data on some risk groups from our recombinant vaccine development programme. Our decision to start this trial in atopic dermatitis now - rather than wait until RFP-2 is awarded - is based on our goal of registering IMVAMUNE(TM) as a safe smallpox vaccine for the general population as soon as possible."
In addition and as reported last week, another Phase l trial with IMVAMUNE(TM) in 90 subjects is underway in the USA. This study will compare IMVAMUNE(TM) to the licensed smallpox vaccine DryVax (R) and will investigate whether the immune response against IMVAMUNE(TM) protects against a subsequent challenge with DryVax (R) . This trial is sponsored by the U.S. National Institute of Health and is expected to be completed in 2005.
The company will also start a Phase l trial in the third quarter of 2004, which will investigate IMVAMUNE (TM) in people with HIV. While Bavarian Nordic has already conducted trials in this risk group in Europe, it will be conducted again in the USA as a requirement of RFP-1. First results of this trial are expected in 2005. Asger Aamund, Chairman of the Board
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