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Gardasil Demonstrates Up to 100% Efficacy

- In the Prevention of Cervical Cancer and Other Human Papillomavirus Related Diseases After an Additional Year of Follow Up in Large Phase III Clinical Studies Which Included More Than 17,000 Women

New England Journal of Medicine publishes the most comprehensive and robust clinical data for any Human Papillomavirus vaccine

LYON, France, 10th May2007 – New clinical study results confirm the high and sustained efficacy of Gardasil® in the prevention of cervical cancer and other Human Papillomavirus related diseases that occur before cervical cancer and beyond the cervix. After three years of follow up in the large phase III clinical studies FUTURE I and II, which included more than 17,000 women, Gardasil® prevented 98% to 100% of pre-cancerous and potentially pre-cancerous cervical lesions (CIN 1-3), pre-cancerous and potentially pre-cancerous vulvar and vaginal lesions (VaIN 1-3 and VIN 1-3), and genital warts caused by Human Papillomavirus types 6, 11, 16 and 18. The results were published today in the New England Journal of Medicine (NEJM). ,

The new three years results substantiate previous phase III results which demonstrated up to 100% efficacy against the same diseases after two years of follow up and on which the licensure of Gardasil® was essentially based. The results also add to other recently presented three years phase III data. The currently available phase III results for Gardasil® are the most comprehensive and robust clinical data presented for any Human Papillomavirus vaccine. Previously presented data from a phase II study had shown Gardasil® to be 100% efficacious against cervical lesions and genital warts after five years of follow up post-enrolment. ,a)

"The efficacy results on which the licensure of Gardasil® was based, were already excellent and very reliable. The new data clearly demonstrate that this high efficacy is likely to persist for a long time. The gap in
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