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Bavarian Nordic outlines production programs for smallpox vaccines
Copenhagen, October 18, 2001



During the last week, Bavarian Nordic`s smallpox program has been the subject of extensive press coverage in both Denmark and internationally. CNN, the Wall Street Journal, New York Times and other media have described the company`s development and manufacturing capabilities in smallpox vaccines, following the events of 11 September and the resulting fear of bioterrorism.

In the following, Bavarian Nordic outlines the current state of its smallpox development and production programs and the expected future planning and communications regarding the project.

Bavarian Nordic A/S is a biopharmaceutical company developing products for the treatment of infectious diseases and cancer. Bavarian Nordic has developed its own vaccine based on the extremely safe MVA-BN strain, which is derived from the seed virus that was used as a pre-vaccine to immunize more than 120,000 people in Germany as part of the smallpox eradication program during the 1970`s. As a third generation product, the MVA-BN vaccine could also be produced in recombinant form, allowing protection against infectious agents other than smallpox that may be used in bioterrorism.

Bavarian Nordic is today able to produce the MVA-BN vaccine in volumes up to 100 million doses for delivery within 12 months (depending on dose strength) and we are currently working on further scaling-up of our production capacity. Once approved as a stand-alone smallpox vaccine, MVA-BN is likely to be the only smallpox vaccine on the world market that can be given safely to immunocompromised persons, such as HIV and cancer patients.

In addition to developing and manufacturing the MVA-BN vaccine, we have the production capacity to manufacture, in large scale, a tissue-culture derived smallpox vaccine comprising an original vaccine strain of Vaccinia based on the Lister-Elstree virus.

Bavarian Nordic can offer our Elstree-BN vaccine in up to 100 million doses for delivery within 9 months. For emergency purposes our production capacity could be expanded with short notice already from the end of this year. During 2002, we expect our full production capacity of the Elstree-BN vaccine to be increased substantially.

To our best understanding, no other vaccine manufacturer with operations in smallpox vaccines has a similar production capacity in these relatively short time spans.

Both vaccines are produced on serum-free media and thus contain no bovine or other animal or human derived substances. All products can be delivered in a freeze-dried form and remain stable upon long-term storage.

Bavarian Nordic`s vaccines are manufactured by a contract vaccine manufacturer with whom we have a long-standing relationship in the production of vaccines for human use. Bavarian Nordic holds the exclusive ownership of all regulatory data and has for and on its own behalf developed the proprietary production process for our smallpox vaccines.

We are in contact with a number of governments who have expressed their wish to collaborate with us concerning development and production of a vaccine for use against smallpox.

Therefore, we are right now in the process of planning and securing the necessary production capacity for the period 2002-2003. Options include expansion of the long-term collaboration with our current contract manufacturer, establishment of a joint-venture with one or more global vaccine producers, and/or phased establishment of our own production facilities in Denmark or internationally.



Yours sincerely,

Mr. Asger J. Aamund, Chairman of the Board

http://www.bavarian-nordic.com

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