The chances of GlaxoSmithKline’s Cervarix reaching the US market anytime soon have disappeared after the company said that it will be the end of 2009 at the earliest before the cervical cancer vaccine gets approved across the Atlantic.

In a reply to the complete response letter issued by the US Food and Drug Administration last December, GSK said that on top of answering the agency’s queries it has decided to augment its application with results from a further Phase III study, called HPV-008. However, final data from the latter are expected to be submitted to the FDA in the first half of 2009 and a decision on the application is anticipated up to six months later.

"Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the US label for Cervarix," Barbara Howe, GSK’s director of North American vaccine development, said. She added that “we continue to have positive and productive discussions with the FDA and remain confident in the vaccine’s safety and efficacy profile”. Interim data from the HPV-008 study were filed in the original application for Cervarix in March 2007 and the company stated that it does not expect that new clinical studies will be needed for approval.

The delay is a problem for Cervarix, which is already available in almost 70 countries, including European Union member states, because it means that Merck & Co’s rival jab Gardasil will have the US market to itself for at least 18 more months. Global sales of Gardasil reached $390 million in the first quarter.

GSK sells Aspen rights to four drugs
Meantime, GSK has agreed to sell the rights to four treatments to South Africa-headquartered Aspen Pharmacare Holdings for £170 million.

Specifically, Aspen has acquired the intellectual property rights outside the USA to Eltroxin (levothyroxine) for the treatment of hypothyroidism, the immunosuppressant Imuran (azathioprine), the cardiovascular agent Lanoxin (digoxin) and Zyloric (allopurinol) for gout. Aspen, which noted that the deal does not include the rights to Zyloric in Japan, said that the four products are sold in over 100 countries and had sales last year of £80 million.

Aspen chief executive Stephen Saad said that the deal “fits perfectly with our international expansion plans and should provide manufacturing opportunities for the group in the future”. It will extend the firm's reach into major markets such as Japan and Europe, he added.