BioWorld International Correspondent

Bavarian Nordic A/S progressed its Imvamune next-generation smallpox vaccine program on two fronts, gaining a U.S. patent for its modified vaccinia Ankara (MVA) BN platform and signing a manufacturing and marketing agreement with GlaxoSmithKline plc.

The Kvistgard, Denmark-based company is vying with Acambis plc, of Cambridge, UK, to win a forthcoming U.S. government contract to supply a stockpile of up to 60 million doses of MVA smallpox vaccine, which has a superior safety profile to the current generation of vaccines. It said the patent grant fulfills a requirement to demonstrate freedom to operate under the U.S. government's request for proposals process. Bavarian Nordic CEO Peter Wulff said, "It will be difficult for others to develop and produce a safe and effective MVA-based vaccine without a license under this patent."

The disclosure of the patent news pushed Bavarian Nordic's share price up to DKK639 (US$106.3) on the Copenhagen Stock Exchange Monday, but a published opinion from Goldman Sachs Group Inc.'s life sciences analyst team in London dampened investor enthusiasm somewhat. Bavarian still closed at DKK605 Monday, up DKK15 from Friday's close. The stock has gained more than 140 percent since the beginning of the year.

New York-based Goldman Sachs, which has an investment banking relationship with Acambis, played down the significance of the patent grant, saying it "has no impact on Acambis or its prospects." A research note from analyst Stephen McGarry said Goldman Sachs confirmed with the National Institutes of Health that "the patent award does not put Acambis at a disadvantage in competing for the U.S. government's MVA smallpox vaccine contracts." Goldman Sachs declined to offer additional comment.

Wulff said Acambis still has to demonstrate that it has freedom to operate under the request for proposal process. "I guess that I can only wait and see if they can provide such evidence," Wulff told BioWorld International. "I cannot comment if they are inside or outside the [Bavarian Nordic patent] claims." Acambis spokeswoman Lynsday Wright said the company is having "ongoing discussions" with the NIH on the issue.

The standoff has been simmering since they received a combined $20 million from the National Institute of Allergy and Infectious Diseases in Bethesda, Md., last year for preclinical and early clinical development of their respective MVA smallpox vaccines. Bavarian Nordic received a contract extension worth up to $23 million in the fall, and the companies now are competing for RFP2, a contract to supply 3 million doses using a validated production process, which is expected to be awarded shortly. The contract to deliver the major stockpile, RFP3, is expected to be awarded next year.

In earlier news, Bavarian Nordic disclosed an agreement with London-based GSK, which, Wulff said, strengthens its global capacity to produce large-scale volumes of its MVA smallpox vaccine, while providing additional assurances of its ability to deliver under the request for proposals process. Bavarian Nordic retains rights in the Nordic countries, German-speaking countries, the Baltic region, China, the Middle East and Southeast Asia. GSK is responsible for North and South America, Japan and a number of EU member states, including the UK and France.

"I think that within the next six to 12 months, you will see tenders from other countries," Wulff said.

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