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Gardasil shows sustained high efficacy in clinical trial

Sanofi Pasteur MSD has announced that its cervical cancer vaccine Gardasil has confirmed sustained high efficacy against precancerous cervical lesions in the longest follow-up of large phase III studies.

Sanofi Pasteur MSD has announced that its cervical cancer vaccine Gardasil has confirmed sustained high efficacy against precancerous cervical lesions in the longest follow-up of large phase III studies.

A combined analysis of four phase I/II studies that included more than 20,000 women confirmed that Gardasil has sustained 98 per cent to 100 per cent efficacy in the prevention of vaccine virus type-related precancerous cervical lesions in young women.

According to Sanofi Pasteur, Gardasil was proved so effective that the studies were ended early so that the women in the placebo group could be vaccinated with the drug.

"The results complete Gardasil's impressive track record of sustained high efficacy. They include by far the longest follow-up for any cervical cancer vaccine in large phase III studies and strongly substantiate the evidence that the protection provided by Gardasil will be long-lasting", said lead study investigator Professor Elmar Joura, from the University of Vienna, Austria.

Study results

In the primary study population of young women (16-26 years), Gardasil prevented 98 per cent of HPV 16/18-related precancerous cervical lesions (CIN2/3 or AIS) according to the combined analysis. Supplementary analyses in a sub-population of young women (16-26 years) revealed 100 per cent efficacy against HPV 16/18-related CIN2/3 or AIS.

The sub-population approximates even better than the primary study population the target group of vaccination programmes (adolescent girls), where maximal benefit of vaccination is expected before exposure to the virus.

The new results are consistent with previous results from the five years follow up of the pivotal phase II study in a smaller population.

"Inferior" Cervarix

According to the Financial Times, Sanofi Pasteur MSD has been touting the benefits of Gardasil, over rival vaccine Cervarix, manufactured by GlaxoSmithKline (GSK).

In meetings with investors this week, Didier Hoch, head of SPMSD, was reported to have claimed that published GSK results on Cervarix were less conclusive and dismissed GSK's clinical study directly comparing the two products as a marketing gimmick.

Hoch said Gardasil had sold 3m courses in Europe last year and generated EUR342m in sales, making it one of the fastest-expanding and highest-earning launches in recent years of any drug or vaccine.

He went on to say that Gardasil had dominated Cervarix, winning market share of more than 90 per cent in most important European markets. The exception, he explained, is Austria, where Gardasil's share of the market is 88.8 per cent, which he said was partly because GSK had offered a discount, selling a course of Cervarix injections at EUR220.

He criticised GSK's head-to-head study of Cervarix and Gardasil for its small sample size, use of people older than the vaccine's target population, and use of a test of efficacy that was not standardised. Finally, the FT said Hoch asserted that claims that Cervarix would provide protection against a number of strains of HPV remained speculative.

7th February 2008

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