GSK claims superiority for Cervarix in head-to-head trial
pharmafile | May 11, 2009 | News story | Research and Development, Sales and Marketing |Â Â GSK, vaccinesÂ
GlaxoSmithKline says a new study shows its cervical cancer vaccine Cervarix induces a higher immune response compared to rival Gardasil.
GSK hopes the head-to-head study will boost the standing of Cervarix, which lags behind Sanofi-Pasteur MSD's Gardasil in the global markets.
Gardasil was first to market, launching in the US and Europe in 2006, and generated sales of $1.4 billion in 2008, while Cervarix earned just $231 million.
Cervarix is still awaiting US marketing approval, and has been adopted as the vaccine in the national immunisation programmes in just two European countries, the UK and the Netherlands.
The FDA has refused to approve Cervarix until the company provides more clinical information, but GSK hopes approval will come later this year.
Cervarix and Gardasil are designed to vaccinate girls and young women to protect against the human papillomavirus (HPV).
There are around 100 types of HPV, but types 16 and 18 are responsible for more than 72% of all cervical cancers in Europe.
Both vaccines target these two virus types, but some clinicians have favoured Cervarix as it also protects against two more strains that cause genital warts.
The new GSK sponsored study shows Cervarix induces a greater immune response to HPV 16 and 18 than its rival.
The presence of antibodies is a first indication of the body's ability to protect itself against disease, but does not necessarily mean Cervarix could prevent more infections than Gardasil.
The study involved 1106 women aged between 18 and 45, showed Cervarix provided significantly higher neutralising antibody levels than Gardasil – more than two times higher for HPV type 16 and more than six times higher for HPV 18.
For both virus strains, Cervarix also induced 2.7 times more memory B cells, another important element of the immune system. The data were announced at the 25th International Papillomavirus Conference (IPV) Sweden.
Thomas Breuer, global head R&D and chief medical officer of GSK Biologicals said: "The presence of neutralising antibodies at the location of the infection (the cervix) appears to be an important part of vaccine-induced protection against HPV. This study offers the first evidence that these two vaccines do not generate the same immune response against HPV types 16 and 18, the two most common cancer-causing virus types.
He added the company was confident that the results, along with others from additional key studies, demonstrated the potential of Cervarix.
Bennett Lee, medical director for Gardasil at Sanofi Pasteur MSD was dismissive of the data.
He told Reuters: "We see no clinical relevance in the results of this study … and we don't see the point of doing such a comparison. If you want to compare vaccines, you compare clinical efficacy."
The comparative data could help GSK's position. One analyst said it could enhance prospects for the product that he expects to increase sales to $1.95 billion by 2013.
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