GlaxoSmithKline’s Cervarix vaccine approved in Europe

26 September, 2007

The European Commission has approved Cervarix, a cervical cancer vaccine manufactured by GlaxoSmithKline, for sale in 27 countries in the European Union.

The move had been expected after a panel of experts at the European Medicines Agency recommended the vaccine in July 2007.

The vaccine has been submitted to the United States Food and Drug Administration (FDA) for approval in the US.

Gardasil, a cervical cancer vaccine made by Merck and Company, has already been approved by the FDA.

Both vaccines are designed to guard against the cancer-causing human papilloma virus (HPV), which is transmitted sexually.

According to the American Cancer Society, over 11,000 women will be diagnosed with cervical cancer in 2007 and nearly 4,000 will die from the disease in the United States.

GlaxoSmithKline is based in London and has a US headquarters in Philadelphia. Merck is headquartered in Whitehouse Station, New Jersey, the United States.

Cervarix, which prevents cancers related to human papillomavirus, can now be prescribed by doctors in 27 countries in the European Union to women and girls aged between 10 and 25 years.

Inoculation with the vaccine is considered most effective in girls before they become sexually active.

If the price is around $100 a dose, Cervarix could generate revenues in $2 billion to $5 billion range in the European Union, based on rival product Gardasil’s performance in the United States, analysts said.

A spokeswoman for GlaxoSmithKline, the world’s second-largest maker of drugs, said Cervarix would go on sale in major European markets in the next few weeks.

GlaxoSmithKline has declined to reveal how much it would charge for Cervarix or whether the European price would be above or below that in Australia, where the vaccine won its first major regulatory approval in May 2007.

Governments around the world have endorsed the concept of vaccinating young girls against HPV, though some groups oppose the idea of routine vaccination against a sexually transmitted virus.

The two vaccines are each expected to become multibillion-dollar-a-year sellers, though many analysts believe that Merck’s first-mover advantage may win it the lion’s share of the business.

GlaxoSmithKline, says reports, thinks it could have an edge over Merck’s vaccine because of the novel adjuvant, or additive, used in Cervarix, which may mean it is more potent and lasts longer.