GlaxoSmithKline has won approval for its new seasonal influenza vaccine FluLaval in the USA, a key element in its major push into the global market for flu vaccines.
GSK added FluLaval to its portfolio of flu products when it acquired the Canadian vaccine manufacturer ID Biomedical last year in a $1.7 billion transaction, and is just one of a series of measures the drug major has in place to boost its presence in the sector.
Last year, GSK's chief executive, Jean-Pierre Garnier, said the acquisition and other capacity expansions at the firm would allow it to manufacture 150 million doses of seasonal flu vaccine a year by the end of the decade.
FluLaval is expected to help GSK capture market share in the important US flu vaccine market, which was blown open by the manufacturing problems that caused Chiron to withdraw its Fluvirin product ahead of the 2004/5 flu season. The company has already launched an assault on the sector with its Fluarix product, which was approved in time for the 2005/6 flu season in the USA and helped offset the supply gap that followed Fluvirin’s suspension.
FluLaval's approval will help GSK compete with Sanofi-Aventis, the other major supplier of flu vaccines into the US market, as Chiron (now Novartis Vaccines) starts to get back on its feet.
The new vaccine, which will be available in 10 dose multi-dose vials, was granted fast track review status by the FDA in July 2005. It is already marketed in Canada under the name Fluviral.
GSK is already one of the world's largest vaccine manufacturers, but believes there is significant growth potential in a market that is shaking off its image as a low-value, commodity sector. The company recently predicted that the global vaccine market could quadruple in size by 2015 to £17-£24 billion from its current level of around £5 billion.