West Coast Editor

With a decision due from the FDA early next year on its ACAM2000 smallpox vaccine, Acambis plc took an order from the feds for 10 million more doses at a price of about $30 million, and disclosed separately that $19 million is due from Novartis AG to settle the dispute over another vaccine.

Still up in the air with the order for 10 million doses of ACAM2000 from the Centers for Disease Control and Prevention (to be supplied from Acambis' existing inventory this year) is the company's bid for a "warm-base" manufacturing contract - that is, one that keeps operations running steadily rather than making batches of vaccine order by order.

"We remain concerned that an award could be an annual one with strict renewal criteria, rather than a guaranteed multiyear one," wrote analyst Robin Campbell at Jefferies International Ltd., the European affiliate of New York-based Jefferies & Co., in a research note. Acambis gets most of its revenue from sales of smallpox vaccine to the U.S. government.

In the settlement related to Acambis' case against Basel, Switzerland-based Novartis AG, the UK firm gets $19 million this month to settle a longstanding fight over Arilvax yellow fever vaccine. Acambis accused Chiron Corp., of Emeryville, Calif. (acquired this spring by Novartis for $1.5 billion) of non-performance under an Arilvax agreement established in 1999 that gave Acambis U.S. sales and marketing rights. Along with the payment, Novartis is granting Acambis an exclusive option to Arilvax worldwide.

Acambis also reported Wednesday a net loss for the second quarter at £12.2 million (US$22.8 million), compared to £4.7 million in the same period last year.

The firm's stock (NASDAQ:ACAM) closed Wednesday at $5.55, down 10 cents.

Grinding along slowly is what Acambis calls "RFP3," the request for proposals related to 20 million doses of another smallpox vaccine, modified vaccinia ankara. Acambis is developing the MVA vaccine in partnership with Baxter Healthcare SA, the European arm of Deerfield, Ill.-based Baxter International Inc., and is submitting information to the U.S. Department of Health and Human Services in the company's effort to win the government contract.

Though victorious, Cambridge, UK-based Acambis could find itself entangled in more court action in the appeal of a decision less than a week ago from the International Trade Commission by Denmark's Bavarian Nordic A/S regarding MVA patents. Officials at Acambis overseas could not be reached, nor did the Cambridge, Mass., office return a phone call or email, but Campbell said "odds are good" that Acambis would prevail during further court skirmishing.

Under a deal with the FDA, Acambis is supplying two unapproved smallpox-related products to the U.S. and other governments. One is ACAM2000, and the other is Toronto-based Cangene Corp.'s vaccinia immune globulin, for which Acambis is Cangene's agent outside North America and Israel.

Acambis' portfolio includes an oral typhoid vaccine, Vivotif, for which the firm has North American sales and distribution rights, and seven other vaccine candidates in testing. The company acquired Vivotif through the 2003 buyout of Berna Products Corp., of Coral Gables, Fla., for $8.4 million cash, which included $3.75 million in potential milestones between 2004 and 2006.

That's the sort of thing Campbell would like to see more of.

"Whilst the RFP3 saga moves into its latest delayed phase (with no firm timetable), investor attention likely alights on the appointment of Peter Fellner to chairman and Acambis' latent [merger and acquisition] ambitions," he wrote, adding that Fellner "can make consolidation happen."

Fellner served as UK-based Celltech Group plc's CEO from 1990 to 2003 and chairman from 2003 until its acquisition by UCB SA, of Brussels, Belgium, in 2004. Before Celltech, he served as CEO of Roche UK.

Other recent news from Acambis included preliminary results this week from the first component of a Phase II trial of its investigational vaccine against West Nile virus, ChimeriVax-West Nile. The primary immunogenicity endpoint was seroconversion rate. More than 97 percent of all subjects who received ChimeriVax-West Nile seroconverted 28 days after a single vaccination, the company said.

Except for a vaccine against Clostridium difficile that recently yielded encouraging Phase I data, and an influenza vaccine in preclinical studies, Acambis' pipeline "needs further investment to bring in additional programs," Campbell wrote. Meanwhile, he characterized the situation at the firm as "in flux."

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