IMVAMUNE(TM) Vaccine - Protection Against Smallpox in 3 Days Bavarian Nordic CEO Peter Wulff Presents Latest Developments

of IMVAMUNE(TM) Smallpox Vaccine at BIO Conference



    WASHINGTON and COPENHAGEN, Denmark, Feb. 24 /PRNewswire/ -- IMVAMUNE(TM),
 a third-generation Modified Virus Ankara (MVA) vaccine under development by
 Bavarian Nordic of Denmark, is expected to be effective against smallpox three
 days after one vaccination compared to traditional replicating vaccines (i.e.,
 DryVax(R)) that only show protection after 10-14 days.
     Presenting today on the status of the company's IMVAMUNE safe smallpox
 vaccine program at the BIO CEO & Investor Conference in New York City, Peter
 Wulff, President and CEO of Bavarian Nordic said: "Based on data from a number
 of our animal models and clinical trials, Bavarian Nordic expects IMVAMUNE(TM)
 to be effective and to protect against smallpox infection 3 days after just
 one vaccination while traditional replicating vaccines only show protection
 after 10 to 14 days."
     The biological mechanism behind traditional replicating smallpox vaccines
 that are available today or under development, takes time to build up in the
 body to a level where an immune response can be detected. Traditional
 replicating smallpox vaccines induce protection over a period of 10 to 14 days
 after vaccination. In contrast, Bavarian Nordic presented data today showing
 that a non-replicating MVA vaccine given at a higher injectable dose induces
 an immune response very quickly, with the added benefit that it is safer than
 the traditional smallpox vaccines.
     In an emergency situation, where protection against smallpox is a top
 priority, IMVAMUNE(TM) has shown in trials to-date to be both a safer vaccine
 with a faster-acting onset of action significantly earlier than traditional
 vaccines.
 
     Background
 
     Need for a safe smallpox vaccine
     All traditional replicating smallpox vaccines have been associated with
 the severe side effects such as encephalitis, generalized vaccinia infection,
 Eczema vaccinatum, local progressive vaccinia infection, and Myo-pericarditis.
     Because of these severe side-effects -- 25% of the population should NOT
 be given current smallpox vaccines. This "at risk" population includes, the
 very young, elderly, pregnant, people who are immune-compromised (HIV-infected
 and AIDS patients, persons with atopic disorders such as eczema as well as
 others). In addition, persons in close contact with this "at risk" group
 should also avoid vaccination with current vaccines due to the risk of
 accidentally exposing the replicating vaccine to these people.
 
     IMVAMUNE(TM) Global Clinical Development and Production
     Bavarian Nordic's global IMVAMUNE(TM) smallpox vaccine development program
 began in 1999 -- long before the events of 9/11 -- resulting today in a strong
 clinical data package making it by far the leading program for registration as
 a safe smallpox vaccine. The company has completed 2 clinical studies in
 Europe, a Phase I study in 86 healthy volunteers and a Phase II dose-finding
 study in 165 healthy volunteers. In addition the company has 3 ongoing
 studies, a Phase I trial comparing IMVAMUNE(TM) to DryVax(R), a Phase I study
 in patients with atopic disorders and a Phase II study in HIV-infected
 patients. In the first two studies, enrolment and vaccination of patients has
 almost been completed. Later this year, Bavarian Nordic will initiate 3 more
 Phase II studies in 2000 subjects, including healthy volunteers and patients
 suffering from atopic disorders. One of the studies will be yet another trial
 comparing IMVAMUNE(TM) to DryVax(R).
     Bavarian Nordic expects to begin production of IMVAMUNE(TM) smallpox
 vaccine at its Danish manufacturing plant this summer.  GlaxoSmithKline is
 Bavarian Nordic's global partner in the manufacture of IMVAMUNE(TM), an
 arrangement that offers extra security to international governmental
 customers.
 
     US Government's MVA program
     Bavarian Nordic is participating in an ongoing US government program to
 develop a safe smallpox vaccine based on the Modified Vaccinia Ankara virus.
 The company has been awarded 2 contracts from the US government under this
 program with a potential value of more than USD 171 million. The third phase
 in this program will be the award of a contract to supply the US government
 with up to 60 million doses of an MVA vaccine to be stockpiled. While the
 government's requirements were expected to be issued in 2004, they are
 anticipated shortly.
     For more information about Bavarian Nordic and IMVAMUNE(TM) please visit
 http://www.bavarian-nordic.com.
 
 

SOURCE Bavarian Nordic

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