Sanofi Pasteur MSD, the firm that sells the cervical cancer vaccine Gardasil in Europe, is hoping to strengthen its lead position in that market and has made a filing aimed at extending use of the jab.
The firm, which is a joint venture between the vaccine arm of Sanofi-Aventis and Merck & Co, noted that it has filed for an update of the license for Gardasil to include the prevention of vulvar and vaginal cancers due to human papillomavirus types 16 and 18. It added that the European Medicines Agency has accepted the filing and started its review.
Extension of its label would do no harm to sales of Gardasil which has enjoyed a monopoly though that is all about to change now that GlaxoSmithKline’s rival product Cervarix has been approved in Europe.
GSK started rolling out its jab this week in the UK and Cervarix is priced at £80.50 per dose (three are required for protection) which is comparable to the cost of Gardasil.
Gardasil, however, also protects against HPV strains 6 and 11 as well as 16 and 18, and thereby offers the benefit of tackling genital warts too, and this, together with its first-to-market advantage, could provide it with a sustained competitive edge over its rival, helping it achieve the $3 billion peak sales target forecast by analysts. GSK, therefore, will be pushing hard to tout any benefits that its offering may have.
But a GSK spokesman told PharmaTimes that the company remains confident in its vaccine, and that results from ongoing clinical trials indicate that Cervarix may offer broader cross-protection against cancer causing types of HPV other than 16 and 18.
Furthermore, he explained, while both vaccines employ the use of adjuvants, which boost the ability of an antigen to stimulate an immune response, Cervarix uses a novel adjuvant known as AS04, which GSK is hoping to prove will give its vaccine an edge over its rival, because it has been designed to produce a longer immune response than vaccines using a traditional aluminium-based adjuvant.
Head to head
Cervarix and Gardasil are currently being assessed head-to-head in a study launched by GSK at the beginning of the year. The main objective of this trial is to compare the immune responses to HPV types 16 and 18 in women aged 18 to 26, while secondary goals will assess this in those aged 27 to 35 and 36 to 45.