GlaxoSmithKline has received a setback in the US after regulators asked for more information about its Cervarix cervical cancer vaccine which could delay its approval for up to two years.
Europe's biggest drug company said it had received a "complete response" letter from the US Food and Drug Administration, which means that more data is needed before the vaccine can be approved. GSK said it will work closely with the FDA to prepare its response as soon as possible.
Cervarix, which protects girls and women against two strains of the sexually transmitted human papillomavirus that causes cervical cancer, is approved in a total of 45 countries, including the 27 member states of Europe. But the setback puts GSK further behind its rival Merck, whose own vaccine Gardasil is already well established in the US. Shares in GSK fell 2 per cent yesterday.
Although the company did not disclose what information the FDA asked for, analysts at Panmure Gordon said it could be in the chemistry, manufacturing and control area and could delay approval for at least six months, and as much as two years if new data were required.
Barbara Howe, director of North American vaccine development at GSK, said: "We have already started addressing the questions and will be engaged in discussions with the FDA to finalise our responses." Cervarix is seen as a vital drug for GSK's growth as it looks for new medicines to replace older drugs which are coming towards the end of their patent. Earlier this year, the company's blockbuster diabetes drug Avandia lost more than half its US sales after a report which linked it to an increased risk of heart attacks.
GSK is seeking to take a bigger slice of the 17bn global cancer market, which is expected to hit 33bn by 2010. Analysts believe Cervarix has the potential to generate 70m for GSK in 2008 and 214m by 2010. Gardasil brought in 207m for Merck in the third quarter. Cervical cancer is the second most common form of cancer among women after breast cancer and kills around 250,000 people a year, according to the World Health Organisation.Reuse content