Glaxo wins EU approval for cervical cancer vaccine

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The Independent Online

GlaxoSmithKline has won approval from the European Commission for its cervical cancer vaccine, paving the way for the launch of its new key product within the next few weeks.

The vaccine, Cervarix, was cleared for sale in 27 countries yesterday and will compete with Merck & Co's Gardasil, which is available in the US and Europe. Both of the vaccines give protection against cancer-causing strains of the sexually transmitted human papillomavirus (HPV) and are expected to become blockbuster drugs after governments around the world endorsed the concept of vaccinating young girls against HPV.

GSK's chief executive Jean-Pierre Garnier, who is to step down in May, said approval "represents a great step forward for European women". "Physicians across Europe will now have access to this important vaccine to help protect women against cervical cancer, the second most common cancer in women," he added. Cervical cancer kills 250,000 women a year, according to the World Health Organisation.

Cervarix is not likely to go on sale in the US before 2008 as it was only submitted to the US Food and Drug Administration in March. Analysts believe the vaccine could generate revenues of £1bn a year by the end of 2011. Sho Matsubara, at Standard & Poor's, said: "This as a solid opportunity for GSK in the preventative cancer vaccine market. We expect Cervarix to share the market with its competitor, Gardasil."

GSK believes its vaccine lasts longer and is more powerful, but analysts said Merck could have the advantage because it gained approval first. Gardasil brought in $358m (£177m) in sales for Merck in the second quarter of the financial year. In phase III, trials Cervarix provided 100 per cent protection against pre-cancerous lesions, which are linked to HPV viruses 16 and 18, which are responsible for 70 per cent of cervical cancer cases worldwide, GSK said. It also provided protection for up to five and a half years after vaccination.

The approval is good news for the company, which is deciding on a successor for M. Garnier, or JP, as he is widely known. GSK has remained tightlipped on the potential candidates but has indicated it will be an internal appointment. David Stout, president of pharmaceutical operations, Russell Greig, head of pharmaceuticals international division, Chris Viehbacher, who is in charge of US pharmaceuticals, and Andrew Witty, the head of European operations, are tipped as likely candidates.

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