BioWorld International Correspondent

LONDON - Acambis plc will be awarded the contract to maintain the U.S. government smallpox vaccine stockpile, according to a notice posted on the Federal Business Opportunities website.

As yet, the timing of the award and its value are not certain, though it is expected to be worth $20 million to $30 million annually over five to 10 years.

"We will only find out the value when the contract is awarded, but we are actively negotiating the details at present," Lyndsay Wright, vice president of communications at Acambis, told BioWorld International.

The so-called "warm base" contract will involve maintaining supplies of the ACAM2000 smallpox vaccine that Acambis has developed and manufactured during the past four years. The company completed filing of the biologics license application for the product last month, submitting data covering 3,800 subjects.

Meanwhile, there were developments in Acambis' various patents disputes with Bavarian Nordic A/S over the MVA smallpox vaccine, the subject of a more lucrative slice of U.S. government business for which the two companies are competing. That $1 billion contract, to supply vaccine suitable for children and people with weakened immune systems, is expected to be awarded before the end of June.

Last week saw the completion of the hearing on a Bavarian Nordic claim against Acambis at the International Trade Commission (ITC) in Washington.

Two days later, Acambis announced that it filed an opposition to Kvistgard, Denmark-based Bavarian's European patent on its MVA-BN technology. "We strongly believe that the patent awarded to Bavarian Nordic in Europe is invalid," said Gordon Cameron, CEO of Acambis. "This belief is supported by evidence presented at the ITC hearing held over the last two weeks."

Acambis' partner, Baxter Healthcare SA, which manufactures MVA3000 in Austria, also has filed an opposition.

The ITC case was narrowed down after the judge excluded Bavarian's claims that Acambis stole its trade secrets and wrongfully obtained MVA material from the U.S. National Institutes of Health that formed the basis of its MVA3000 vaccine.

That narrowed the scope of the hearing solely to the question of whether Acambis infringed Bavarian's U.S. MVA patents. The initial decision is due Aug. 24, after which it will be reviewed by the ITC commissioners who are required to give a final decision by the end of November.

The trade secrets claim was excluded by the ITC because Acambis and Bavarian signed a confidential disclosure agreement in February 2002, requiring disputes to be settled in Frankfurt, Germany, under the rules of the International Chamber of Commerce. However, the trade secrets aspect remains part of another action by Bavarian brought before the District Court of Delaware.

Bavarian has filed an infringement action in Vienna, Austria, also. That case can't be heard until oppositions to the European patent are decided. All of which means that the contract for the MVA stockpile will be announced before the various intellectual property disputes are settled.

"We don't expect the [ongoing disputes] to have any effect on the award of the contract," Wright said. The original specification from the U.S. Centers for Disease Control and Prevention in Atlanta said bidders would need to demonstrate freedom to operate, but that was taken out of the Request For Proposals. "I think [the CDC] took the view, you get on with sorting out the patent issues; we'll get on with the contract," Wright said.

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