GlaxoSmithKline: FDA delays Cervarix approval
12/18/2007 web-based article Hedwig Kresse www.pharmaceutical-business-review.com The FDA has requested further information for GSK's cervical cancer vaccine. With Merck & Co's blockbuster Gardasil currently the only approved HPV vaccine in the US, the FDA approval of Cervarix would represent a significant commercial milestone for GSK. However, the market delay now facing Cervarix is likely to restrict its impact and will enable Gardasil to retain a monopoly position in the crucial US market until the agency's unspecified issues are resolved. Cervical cancer, killing over 280,000 women worldwide each year, is causatively linked to the human papillomavirus (HPV), which is spread by sexual contact. Recently, both Merck and GSK have launched vaccines which could protect against infections with HPV if administered to young girls before they become sexually active. These products have a significant commercial opportunity: Datamonitor predicts annual cohort sales of $1.4 billion for the seven major markets by 2016. In addition, there is a significant catch-up opportunity in young women aged 13-26, which could be worth over $17 billion by 2016. Comparing the two vaccines, Gardasil has numerous advantages over Cervarix: From a clinical point of view, it has a wider coverage than Cervarix, protecting against HPV subtypes 6 and 11, which cause genital warts in addition to the cervical cancer subtypes 16 and 18, which are also contained in Cervarix. Furthermore, Merck has been able to show significant cross-protection against further subtypes not included in the vaccine. In addition, data presented in November 2007 demonstrate excellent efficacy of Gardasil [...]