Source: EP Vantage (originally posted 30 Sept 2011)
As the global debate about the cost effectiveness – and in some places ethics – of human papilloma virus (HPV) vaccines rumbles on, Merck & Co has been quietly working away on a 21,000 patient phase III program for an improved version of its blockbuster vaccine Gardasil.
Relatively little is known or has been written about the new candidate dubbed V503, yet it currently ranks as Merck’s second most valuable pipeline product at just under $1bn. As a 9-valent vaccine V503 has the potential to protect girls and young women from cervical cancer caused by a wider range of types of HPV than the quadrivalent Gardasil. Results from a 15,000-patient trial of V503 compared to Gardasil should be released within a few months when HPV vaccines will be in the spotlight once more. Positive results would provide Merck with more ammunition in the still two-way battle with GlaxoSmithKline’s Cervarix.
Gardasil entered the market first in 2006 and made spectacular use of its first-mover advantage – the vaccine raked in global sales over $2bn in 2007, its first full year on the market.
However, revenues peaked in 2008 at $2.41bn, falling back to $1.36bn last year and they are currently predicted to slowly decline over the next six years. As it stands vaccination with Gardasil requires three injections over seven months but there is no requirement for booster jabs, meaning that use of the vaccine in teenage girls quickly reached saturation point in many countries.
Meanwhile Merck’s attempts to expand use of the vaccine into older women failed to gain regulatory approval and sanctioning of the product to protect boys and men from genital warts has been a marginal opportunity (Boys prove to be of little value to Merck, September 10, 2009).