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Chiron Can’t Yet Predict How Many Flu Doses It Will Produce

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Times Staff Writer

The chief executive of Chiron Corp. said Thursday that it was too early to predict how many doses of flu vaccine the company would produce at its troubled factory in Britain this year.

Speaking at a news conference, Howard Pien said the company had made substantial changes at the Liverpool plant and did not yet know the limits of its new manufacturing system.

Pien said the company hadn’t determined the “optimal number of eggs” the factory could process and still “avoid contamination.” Flu vaccine is made in chicken eggs.

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Chiron was trying to “learn lessons from last year’s disappointment,” Pien said.

The plant was closed last fall by regulators in Britain because they had found sloppy manufacturing practices and bacterial contamination. The action cut the total U.S. supply in half and caused public health authorities to ration vaccine.

Chiron resumed production in the Liverpool plant Wednesday after it received clearance from the British Medicines and Healthcare Products Regulatory Agency.

The company must submit weekly progress reports to British regulators and pass a U.S. Food and Drug Administration inspection that is expected to take place when production is in full swing.

“They have to meet all the FDA requirements and they have to actually produce the vaccine,” said Geoffrey Porges, an analyst with Sanford C. Bernstein. “This company is not out of the woods yet.”

Porges said he believed Chiron would produce 30 million does this year; others on Wall Street have predicted 35 million. Chiron had attempted to manufacture 52 million doses for the 2004-05 flu season.

Regulators in Britain said increased production last year exacerbated Chiron’s problems, but the company has maintained that the ramp-up wasn’t a factor.

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A shortage of shots isn’t expected for the next flu season because a new supplier, GlaxoSmithKline, plans to enter the U.S. market with 10 million to 15 million doses. Analysts believe that the other major supplier besides Chiron, Sanofi-Aventis, will make close to 50 million doses.

Separately Thursday, Chiron disclosed in a regulatory filing that John Lambert, who resigned as head of the company’s vaccine business last week, received $1.75 million in severance pay.

Chiron shares fell 14 cents to $37.55 on Nasdaq.

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