• 5/26/2004
  • Datamonitor Services

GSK is awaiting the outcome of a Phase III trial to evaluate an anti-cervical cancer vaccine.

GlaxoSmithKline’s [GSK.L] four-year clinical trial of an HPV vaccine could have a significant affect on cervical cancer treatment, as HPV is a known contributory factor to the disease. However, GSK will need to consider how this product should be positioned, especially with regard to use in pediatrics, so as to maximize revenues.

GSK’s global Phase III PATRICIA HPV vaccine trial will involve 90 sites and approximately 13,000 young women aged 15-25 worldwide, lasting for approximately four years. HPV is associated with cervical cancer, the second most common cause of cancer in women worldwide, and the leading cause in the developing world. Furthermore, cervical cancer develops early in life, with a median age of 38 years. Although there are more than 100 different types of HPV, approximately 70% of all cervical cancers are associated with just two types, namely HPV 16 and HPV 18. It is against these oncogenic strains that the HPV vaccine is intended to confer protection.

GSK’s main challenge will be identifying the optimal target population. Judging by the proposed trial, it can be inferred that GSK anticipates its target population to be young women, from mid-teens to early twenties. This means that the HPV vaccine will not be included on the US pediatric immunization schedule, which is the most commercially attractive sector for vaccine manufacturers due to its large patient population and high compliance rates. Consequently, GSK will need to advertise the medical need for HPV vaccination to drive uptake in this patient group, a significant task considering that a recent survey revealed that only 30% of women in the UK have heard of HPV, let alone a link with cancer. Furthermore, targeting this age group may result in vaccination after individuals have become sexually active.

GSK may consider instigating trials in children to gain access to the pediatric market. However, GSK will need to address whether cervical cancer poses so great a medical problem as to warrant approval in this age group. Furthermore, inclusion of a vaccine against a sexually transmitted disease will face opposition from groups claiming such actions promote promiscuity. Nevertheless, depending on the outcome of the PATRICIA trial, the HPV vaccine should be commercially successful, but adopting an appropriate marketing strategy will determine the extent of its success.