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Australian Flu-Vaccine Firm Talks With FDA

Posted on: Tuesday, 7 February 2006, 12:00 CST

By Linda Loyd, The Philadelphia Inquirer

Feb. 7--An Australian company with U.S. operations in King of Prussia is in talks with the Food and Drug Administration to sell as many as 20 million doses of its seasonal influenza vaccine in the United States.

Australia's CSL Ltd. and its King of Prussia subsidiary ZLB Behring, a blood-products firm, plan to introduce an influenza vaccine in the United States by 2007-08, if the FDA approves.

Having more manufacturers of flu vaccine licensed in the United States, and having more vaccine doses, is seen by many as important to public health. The goal of the U.S. Centers for Disease Control and Prevention is to have 185 million Americans vaccinated annually, but supply limitations have made that impossible.

"We welcome any new companies into the market, and hopefully that will alleviate any future shortages," said CDC spokesman Curtis Allen.

Brian McNamee, CSL chief executive officer and managing director, said in an interview that his company had already had "a fair amount of" discussions with the FDA. "We think we can provide doses for the 2007-08 season in the United States," he said.

CSL, a global biopharmaceutical company that has manufactured flu vaccine outside the United States since 1968, said it was investing $60 million in its Melbourne plant to double manufacturing capacity to about 40 million flu doses a year.

FDA spokesman Stephen King declined yesterday to confirm discussions with CSL, saying the agency did not "comment on any pending applications."

McNamee will be in New York today at a Merrill Lynch & Co. Inc. investor conference to discuss the flu-vaccine expansion plans, the company said.

CSL sells 15 million to 20 million flu-vaccine doses in 16 countries, mostly in the Southern Hemisphere and Europe. The company sells bulk influenza vaccine in 24 countries. In Britain, the company says, one in four flu-vaccine doses this season was a CSL product.

ZLB Behring, which makes blood-protein therapies to treat rare diseases, will be responsible for sales and distribution of the flu vaccine to U.S. hospitals, doctors, clinics and retail pharmacies, said Paul Perreault, ZLB Behring executive vice president of commercial operations.

ZLB Behring will hire staff "dedicated to vaccines," Perreault said, including a commercial head for marketing and a project manager for global sales, "because we plan on bringing the vaccine to other markets outside the United States eventually."

ZLB Behring will eventually hire 15 to 20 employees for the vaccine group, but will use existing large distributors to get the vaccine to health-care providers and pharmacies. "My assumption is we would go through distribution channels and not put out a whole new sales force," Perreault said.

As part of the FDA approval process, CSL said it would test its vaccine in a human clinical trial this year and present the data within 12 months when it files for a biologics license with the FDA. CSL said it planned to manufacture two versions containing inactivated influenza virus: a formulation for adults and a preservative-free version for children.

For the current 2005-06 U.S. flu season, about 87 million flu-vaccine doses were produced for the United States -- with more than 80 million distributed so far -- by four manufacturers: Sanofi Pasteur, Chiron Corp., GlaxoSmithKline P.L.C., and MedImmune Vaccines Inc.

Allen, the CDC spokesman, said Sanofi Pasteur produced about 63 million doses for the U.S. market; Chiron manufactured about 14.6 million doses; GlaxoSmithKline supplied 7.5 million U.S. doses; and MedImmune, which makes a nasal-spray vaccine, about 2 million doses.

Manufacturers' goal for the 2006-07 flu season is 115 million to 120 million doses, Allen said.

CSL's 20 million doses, if approved by the FDA, would be "quite material to the U.S. market," said McNamee. "We provide geographic and seasonal diversity. We are on the other side of the world."

Shares of CSL trade on the Australian stock exchange.

Contact staff writer Linda Loyd at 215-854-2831 or lloyd@phillynews.com.

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Copyright (c) 2006, The Philadelphia Inquirer

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Source: The Philadelphia Inquirer

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