The positive opinion for a drug in the EU always precedes final regulatory approval, which should happen for Cervarix in the next several months. Following approval, GSK will then negotiate reimbursement within the individual EU countries, so sales should begin ramping up around the start of 2008. Cervarix is also awaiting regulatory approval in the U.S. after GSK filed a marketing application in March.
GlaxoSmithKline rival Merck
Merck's and GSK's vaccines are different, and each has its own advantages. Gardasil is effective against the HPV strains that cause genital warts, whereas Cervarix may confer a longer period of protection versus Gardasil for the two main strains of HPV that cause approximately "70% of HPV-related cervical cancer cases."
GSK is testing Cervarix against Gardasil in a phase 3 study to see which one will perform better over time in protecting women against the main cancer-causing HPV strains. Success in this study, which will take several years to complete, would be very good for marketing purposes -- although it won't be anything close to a conclusion to the vaccine wars, which are just about to heat up.
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