GSK’s Cervarix gets European green light
pharmafile | July 25, 2007 | News story | Sales and Marketing |Â Â Â
Cervarix, the cervical cancer vaccine from GlaxoSmithKline has received a positive opinion from the European medicines regulator, meaning it could reach the market before the end of 2007.
The vaccine still needs final marketing approval, but this is expected to follow within the three months.
GSK's product is a rival to Sanofi-Pasteur MSD's Gardasil, the first ever vaccine to prevent girls and women developing cervical cancer by blocking the human papillomavirus (HPV) which causes most cases of the killer disease.
Sanofi-Pasteur's Gardasil was launched in October last year, and has been accepted onto government vaccination programmes in countries across Europe as well as the US, with the promise of preventing thousands of deaths every year.
In the UK alone, there are 2,800 new cases of cervical cancer every year, despite a national cervical screening, known as the smear test.
Screening has dramatically reduced deaths since its introduction in the 1960s, but around 1,000 women in the UK still die from cervical cancer every year.
Being the second product to reach the market, Cervarix will have to differentiate itself from Gardasil in order to challenge its position.
One key claim Cervarix has over its rival is that it is formulated with a new technology which enhances the immune response and increase the duration of protection against cancer-causing virus types.
GSK has demonstrated confidence in its product by beginning a head-to-head trial of Cervarix with Gardasil in January this year.
The company hopes the study will demonstrate that women show a greater immune response to Cervarix than Gardasil in relation to the two most common strains of the human papillomavirus, HPV 16 and 18, which are responsible for at least 70% of all cases.
Despite this, many analysts think Gardasil's head start will help it capture the market, with peak sales forecast currently around $2.5 billion compared to Cervarix on $1.5 billion.
