By Andrew Jack in London, FT.com July 1 2008 03:00
GlaxoSmithKline, the UK-based pharmaceutical company, is unlikely to receive US approval for its key cervical cancer vaccine until 2010 at the earliest, under a new timetable it released yesterday.
After requests for fresh information on Cervarix from the Food & Drug Administration in December, GSK said it had decided to await completion of a pivotal clinical trial to be filed with the US regulator during the first half of next year.
Cervarix is a probable blockbuster treatment that is central to the company’s future growth. The cervical cancer vaccine market is expected to be worth more than $1bn a year in sales.
GSK’s timetable change confirms long-standing analysts’ fears of delays for Cervarix, which is competing with a rival vaccine, Gardasil, produced by Merck of the US and already on sale in north America.
GSK filed originally for US approval from the FDA in March 2007, and it has refused to reveal the regulator’s precise concerns other than to say they relate to “safety and efficacy”.
Observers believe the queries focus on the nature of Cervarix’s proprietary adjuvant, a chemical that boosts the immune response to the vaccine. The FDA has not approved a new adjuvant since the 1930s.
Cervarix has been approved for sale in 67 countries, including across Europe, which has sparked an intensifying competition for contracts between Merck and GSK in recent months.
GSK said it was confident in the data that would be generated later this year from its long-term efficacy trial, HPV-008, which has monitored progress in those vaccinated over the past four years.
Barbara Howe, GSK’s vice- president and director for north American vaccine development, said: “We continue to have positive and productive discussions with the FDA and remain confident in the vaccine’s safety and efficacy profile.”
In signs of fresh restructuring, GSK also yesterday said that for the first time since its creation by merger in 2000, it had divested most international rights to four of its medicines, including one still on patent.
It has sold the rights for Eltroxin, Lanoxin and Imuran outside the US, and Zyloric outside the US and Japan, to Aspen of South Africa, for £170m ($338m), handing the company product sales that generated £80m last year.
The deal marks a new step in the expansion of the generics sector, and consolidation of GSK’s links with Aspen, to which it had already licensed production of more than 40 of its medicines for South Africa, including its antiretroviral HIV medicines for subSaharan Africa.