CSL to enter US flu market, double vaccine capacity

Biopharmaceutical company CSL (ASX:CSL) will invest AUD$80 million in plant and equipment to double capacity at its Melbourne facility to 40 million doses per season, making it one of the largest vaccine manufacturing plants in the world.

"Initially, the additional capacity as it ramps up will be directed to the US but there are other customers that we have that can use it as well," said CSL director of public affairs Rachel David. "This is a new market for us and it's a market of significant size."

David said that CSL is expanding its capacity because demand for flu vaccine greatly currently exceeds supply.

"That's been as a result of pharma shortages but also a result of increased interest globally in protecting against the flu which has come as a result of the fear of the pandemic and other things," said David. "So even though this is seasonal flu vaccine, flu has really put on the agenda as a difficult issue."

CSL is planning to initiate a human clinical study of its vaccine in the US in the next couple of months, said David, and to submit a Biologics License Application (BLA) to the FDA within 12 months.

If regulatory approval is obtained, CSL intends to have vaccine available for the 2007-08 US flu season. The expanded plant will come online in 2008 and the company intends to supply up to 20 million doses to the US.

"We obviously manufacture seasonally, so we'll be manufacturing for the southern hemisphere countries as well as for the northern hemisphere," said David. "We already export a very large amount of flu vaccine into Europe, last flu season about 1 in 4 people in the UK were vaccinated with the CSL product."