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Bavarian Nordic Positive to Broader Usage of Safe Smallpox Vaccine


WASHINGTON, Aug. 24 -- Bavarian Nordic, the Danish biopharmaceutical company developing a new, safer smallpox vaccine (Imvamune(tm)), commended the U.S. government for broadening the usage of MVA-based smallpox vaccines beyond those who are immune-compromised.

Peter Wulff, president and CEO, Bavarian Nordic, said, “We are pleased that the U.S. government has issued RFP-lll and that the process for the procurement of an initial 20 million doses of MVA-based smallpox vaccine has begun. We have reviewed the tender requirements and with pleasure noted, that the government has decided, that in addition to immune-compromised individuals, to procure MVA-based smallpox vaccine for the portion of the population who are not considered to be at high-risk to experience the side-effects associated with traditional smallpox vaccines. This change of attitude on the usage of MVA smallpox vaccine indicates that a decision about replacing the entire existing smallpox vaccine stockpile with MVA-based smallpox vaccines could be on the way.”

Bavarian Nordic also announced the following highlights for the half of 2005:

Key highlights (1 Jan. to 30 June, 2005)

-- Revenue was DKK 142 million (as of 30 June 2004: DKK 118 million)

-- Result before tax was a deficit of DKK 23 million (as of 30 June 2004: profit of DKK 13 million)

-- Approximately DKK 417 million was generated in new capital from a fully-subscribed rights issue.

-- Expectations for the financial result for the full year 2005 are maintained at revenues of DKK 450-500 million, which include sales of Elstree-BN smallpox vaccines, and a net result of DKK 0.

-- According to plan, the Kvistgard facility moved into operation and the transfer of the MVA-BN(r) production process from IDT was completed. The company’s quality system and quality control laboratory at the facility have been approved by the Danish Medicines Agency.

-- At the end of June, Bavarian Nordic had vaccinated more than 470 subjects (healthy volunteers and those with contra- indications to conventional smallpox vaccines) with MVA-BN(r)- based vaccines without any serious or unexpected adverse reactions.

-- Imvamune(tm) is expected to be effective in protecting against orthopox infection 3-4 days after vaccination with a single dose of IMVAMUNE(tm) in contrast to traditional smallpox vaccines that first protect 10-14 days after vaccination.

-- Results from the MVA nef vaccine development program as reported in the scientific publication Antiviral Therapy demonstrated that MVA nef is safe and immunogenic in HIV-infected persons and has potential as a vaccine for the treatment of HIV infection and AIDS. A Phase II trial in 75 HIV-infected subjects with more advanced stages of HIV infection is underway. Half of the subjects have received the vaccination in this trial.

-- Results from a pre-clinical trial published in the Journal of Virology demonstrated that Imvamune(tm) protects monkeys from a lethal challenge with monkeypox, a closely-related virus to smallpox. Animal data is the only approved method to demonstrate efficacy of a smallpox vaccine against smallpox infection in humans. The monkey model developed by Bavarian Nordic is a major step forward in the company’s goal to register Imvamune(tm). With these new results, Imvamune(tm) is the only vaccine candidate in the RFP program with this critical efficacy data.

Events after close of reporting period (1 July - 21 Aug., 2005)

-- On 19 Aug., Bavarian Nordic took steps to enforce its intellectual property rights by filing two legal actions against Acambis. Bavarian Nordic A/S filed a patent infringement action against Acambis plc’s MVA smallpox vaccine at the U.S. International Trade Commission and a misappropriation of trade secrets case against Acambis plc and Acambis Inc. at the US federal district court based in the state of Delaware.

-- The U.S. government issued on 15 Aug. their tender terms, or RFP-lll, for the initial purchase of up to 20 million doses of MVA-based smallpox vaccine. The terms include delivery of MVA smallpox vaccines at a fixed-dose price as well as deliveries based on a cost-plus principle. Contract(s) will be awarded to one or more companies. According to the U.S. authorities, proposals must be submitted to HHS by September 29, 2005 and contract(s) will be decided in February 2006.

-- All 60 subjects in a trial that evaluated the safety and immunogenicity of Imvamune(tm) in patients with atopic dermatitis or history of atopic dermatitis have received two vaccinations without any serious or unexpected adverse reactions. This is the first study with an MVA- based smallpox vaccine in this population, which is known to be at greater risk for serious side-effects from conventional smallpox vaccine.

-- As scheduled, test-manufacturing of the industrial scale MVA-BN(r) manufacturing process at the Kvistgard site began. Commercial manufacturing of Imvamune(tm) is expected to start as planned, in September.

-- A patent issued to Bavarian Nordic on an MVA-based vaccinia virus from the United States Patent and Trademark Office (USPTO) further strengthened the company’s intellectual property position on MVA.

The entire statement regarding Bavarian Nordic’s highlights and results for the first six months of 2005 can be obtained at:


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