BioWorld International Correspondent

Danish firm Bavarian Nordic A/S edged ahead of UK rival Acambis plc in the race to develop and deliver to the U.S. authorities a third-generation smallpox vaccine that can be safely administered to immunocompromised individuals.

Copenhagen-based Bavarian Nordic last week disclosed that it received an award worth up to $23 million from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health in Bethesda, Md., to fulfill the second phase of a modified vaccinia ankara (MVA) vaccine development program. Earlier this year, the NIAID awarded $20 million to Bavarian Nordic and Cambridge, UK-based Acambis to conduct preclinical and early clinical development of their respective MVA smallpox vaccines and to develop plans for the production of up to 30 million doses. (See BioWorld International, March 5, 2003.)

Bavarian Nordic attained sufficient milestones in that phase of the program to trigger the contract extension, which will involve Phase I and Phase II trials in healthy volunteers and Phase I trials in immunocompromised individuals, including subjects with HIV infection. "It takes effect immediately," Bavarian Nordic CEO Peter Wulff told BioWorld International.

Acambis' rival program has not reached the same point, and the company has yet to disclose when it will. "We're not giving a time scale on that beyond saying sometime in 2004," Communications Director Lyndsay Wright told BioWorld International.

MVA vaccines are highly attenuated and do not replicate in humans, giving them a better safety profile than current vaccines. Bavarian Nordic has already filed with the FDA its first investigational new drug application for its smallpox vaccine, MVA-BN, Wulff said, and is finalizing others for study in different target populations.

"[They] will certainly include HIV-infected and immunocompromised people," he said. MVA-BN has undergone a Phase I trial involving 86 healthy volunteers in Germany. A Phase II trial involving 165 healthy volunteers is under way, also in Europe. It has completed delivery of the product to the UK government and is midway through a shipment of 1 million doses to German authorities.

The company also is looking to acquire large-scale production capacity.

"We are gearing up our organization to be able to start manufacturing on an industrial scale within the next 18 months," Wulff said. The company is pursuing a dual strategy in that respect. Since the beginning of the year, it has been developing plans to build its own facility. "In parallel, we have been pursuing a number of acquisition targets, and we are pretty advanced [in discussions] with these targets," Wulff said. The company aims to reach a decision within the next two months. Pursuing the former option, Wulff said, would not entail a major delay.

"Our best estimate is we will only lose three months," he said.

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