GlaxoSmithKline has received a major boost from the news that the UK’s Department of Health has chosen the firm’s cervical cancer vaccine Cervarix for the country’s human papillomavirus immunisation programme ahead of rival jab Gardasil.
The programme, which aims to protect against the two types of HPV (16 and 18) that are responsible for approximately 70% of cervical cancers, will start in September and will vaccinate girls aged 12 to 13 each year. There will also be a catch-up scheme for girls aged 14 up to 18, which will be implemented over the next two to three years.
The DoH said it backed GSK’s jab after an adjudication was carried out to “carefully examine the vaccines offered against a wide range of criteria such as their scientific qualities and cost effectiveness”. The criteria used had been shared in advance with the companies which tendered and based on this assessment, the DoH plumped for Cervarix ahead of Gardasil which is sold in Europe by Sanofi Pasteur MSD, a joint venture between Sanofi-Aventis and the vaccine’s developer Merck & Co.
The cost of the vaccine is “commercially confidential”, said the DoH, which noted that the jab will be supplied free of charge on the National Health Service. Health Minister Dawn Primarolo said Cervarix “could save the lives of 400 women a year” and it is “an exciting opportunity to immunise young girls against the future risk of cancer, the impact of which will be felt by women and their families for generations to come”.
Getting the governmental nod from the government could provide GSK with benefits that extend beyond the UK. Although Cervarix is already approved in 64 countries, the DoH deal is the first major national tender for which GSK has bid, or indeed won. It reflect one of the largest HPV national immunisation programmes anywhere to date, GSK noted, adding that it looks forward to working “with more governments around the world”.
Unsurprisingly, the decision did not go down well at Sanofi Pasteur MSD. The JV said the UK authorities’ move to choose a two-type HPV vaccine “means that the girls in this campaign will not benefit from the world’s leading four-type (6,11,16,18) HPV vaccine”, ie Gardasil.
Nicholas Kitchin, the venture’s UK Medical Director, went on to say “we regret that school girls in the UK, unlike most of their peers in Western Europe, the USA, Australia, New Zealand and Canada, will not benefit from the unmatched cervical cancer protection and additional benefits” provided by Gardasil, which was launched two years ago and two years after its first launch in has 95% global market share.
Nevertheless the DoH’s decision represents a clear victory for GSK which has much work to do to start getting some of that market share. Though Cervarix got the green light in Europe last October, two months later, the US Food and Drug Administration said it wanted more information before approving the jab. The problem is not thought to be one of safety or efficacy and GSK hopes approval will be given in the very near future.
