Glaxo Seeks Entry Into U.S. Flu Vaccine Mkt

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GlaxoSmithKline Plc is exploring ways to sell its Fluarix flu vaccine in the United States, where supplies have run short this season after Chiron Corp lost a year’s production to contamination.

A spokeswoman for the British-based company on Monday said GSK wants to market Fluarix in the U.S. market and is examining both short- and long-term options with the U.S. Food and Drug Administration.

"GlaxoSmithKline is in ongoing discussions with FDA regarding the possibility of bringing Fluarix to the United States,” she said, adding the move could eventually involve increasing production at the company’s main flu vaccine facility at Dresden, Germany.

“GlaxoSmithKline would like to provide a long-term solution and have Fluarix licensed in the U.S., thus helping alleviate future concerns regarding flu vaccine shortages in the U.S.”

At the moment, GSK’s product is sold in some 70 countries around the world—but not in the United States, since the company decided at the time of its launch in 1992 that the U.S. market was over-crowded.

Today, however, the U.S. relies on just two companies to supply injectable flu vaccines and one of them will not be able to deliver this season.

British regulators revoked Chiron’s flu-vaccine license last week after finding widespread problems at its plant in Liverpool, northern England, in a move that puts 48 million doses destined for the U.S. out of reach.

GSK said it was talking with FDA officials about the possibility of granting Fluarix speedy approval for sale in the U.S. this season—although it is unlikely this will make a significant difference to the supply picture.

The vast majority of the company’s flu vaccine is already committed to customers under long-term contract, leaving perhaps only around 200,000 doses available for shipment elsewhere.

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