IMVAMUNE Vaccine -- Protection Against Smallpox in Three Days

WASHINGTON and COPENHAGEN -- 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 that only show protection after 10-14 days.

"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," says Peter Wulff, president and CEO of Bavarian Nordic, presenting today on the status of the company's IMVAMUNE safe smallpox vaccine program at the BIO CEO & Investor Conference in New York City.

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 has been shown in trials to be both a safer vaccine with a faster-acting onset of action significantly earlier than traditional vaccines.

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 myopericarditis.

Because of these severe side effects, 25 percent 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 Global Clinical Development and Production

Bavarian Nordic's global IMVAMUNE 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 three ongoing studies: a phase I trial comparing IMVAMUNE 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, enrollment and vaccination of patients has almost been completed. Later this year, Bavarian Nordic will initiate three 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 to DryVax.

Bavarian Nordic expects to begin production of IMVAMUNE smallpox vaccine at its Danish manufacturing plant this summer. GlaxoSmithKline is Bavarian Nordic's global partner in the manufacture of IMVAMUNE, an arrangement that offers extra security to international governmental customers.

U.S. Government's MVA Program

Bavarian Nordic is participating in an ongoing U.S. government program to develop a safe smallpox vaccine based on the Modified Vaccinia Ankara (MVA) virus. The company has been awarded two contracts from the U.S. government under this program with a potential value of more than $171 million. The third phase in this program will be the award of a contract to supply the U.S. 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.

Source: Bavarian Nordic

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