Studies Demonstrate Gardasil® Has Long Duration of Protection From HPV Disease

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Studies Demonstrate Gardasil® Has Long Duration of Protection From HPV Disease PR Newswire LYON, France, December 6, 2012 LYON, France, December 6, 2012 /PRNewswire/ -- Data represents the largest follow-up available for an HPV vaccine Data from two large, long term follow-up studies continue to show that vaccination with Gardasil offers a long duration of protection from human papillomavirus (HPV) diseases related to HPV types 6, 11, 16 and 18. HPV-related diseases include cervical cancer and genital warts. thThe interim data, presented at the 28 International Papillomavirus Conference (IPV) in Puerto Rico, showed that young [1] [2]women and adolescent girls and boys vaccinated with Gardasil were protected from HPV-related diseases for up [3]to eight years following vaccination. Furthermore, data on immunogenicity (the degree to which an immune response is induced) showed that immune levels remained high for nine years following vaccination. "These latest data show an encouraging trend of continued protection with Gardasil against HPV-related cervical, vaginal and vulvar disease in women through eight years," said Professor Susanne Krüger Kjær, Danish Cancer Society. "These studies provide further evidence for the ongoing efficacy, immunogenicity, and safety of Gardasil." The European studies were conducted in Sweden, Denmark, Norway and Iceland.

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• Publié par: Sanofi-Pasteur-MSD
• Nombre de lectures: 11
• Langue: English

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Studies Demonstrate Gardasil® Has Long Duration of Protection From HPV Disease

PR Newswire LYON, France, December 6, 2012

LYON, France,December 6, 2012/PRNewswire/ --

Data represents the largest follow-up available for an HPV vaccine

Data from two large, long term follow-up studies continue to show that vaccination with Gardasil offers a long duration of protection from human papillomavirus (H PV) diseases related to HPV types 6, 11, 16 and 18. HPV- related diseases include cervical cancer and genital warts.

th The interim data, presented at the 28 International Papillomavirus Conference (IPV) in Puerto Rico, showed that [1] [2] young women and adolescent girls and boys vaccinated with Gardasil were protected from HPV-related [3] diseases for up to eight years following vaccination. Furthermore, data on immunogenicity (the degree to which an immune response is induced) showed that immune levels remained high for nine years following vaccination.

"These latest data show an encouraging trend of continued protection with Gardasil against HPV-related cervical, vaginal and vulvar disease in women through eight years," said Professor Susanne Krüger Kjær, Danish Cancer Society."These studies provide further evidence for the ongoing efficacy, immunogenicity, and safety of Gardasil".

The European studies were conducted in Sweden, Denm ark, Norway and Iceland. One study followed young women aged between 16-23 years and the second study followed adolescent boys and girls between 9-15 years. The studies will continue tracking the study participants for at least 14 years.

Benoit Soubeyrand, Executive Director, Medical Affairs for Sanofi Pasteur MSD, stated: "Thesedatatellusthat Gardasil can in effect help protect people from HPV diseases during the entire period when they are most at risk-from adolescence into early adulthood. That's nearly a decade of protection thatcouldsavemanylives over time."

More than 100 million doses of Gardasil® have been distributed worldwide since 2006.

Notes to Editors

About the studies

[1] The Scandinavian study among young women is an extension of the pivotal P hase III FUTURE II clinical trial of Gardasil. The study is being conducted through the national health registry systems in four Nordic countries: Denmark, Iceland, Norway and Sweden. Because of the extensive nationwide registers in these countries, it is possible to conduct follow-up studies that can track the health of the study participants well into the future, beyond the original study's timeframe. The Long Term Follow-Up (LTFU) study evaluated effectiveness against the early stages of cervical cancer, vulvar cancer and vaginal cancer related to HPV types 6/11/16/18. Data from this Scandinavian study showed a trend of continued protection, with no breakthrough cases of disease, through eight years. Analysis and observation of the study participants will be followed for 10 years, for a total of 14 years post vaccination.

[2] The study among adolescent girls and boys aged 10-15 years followed a randomized, double-blind trial of 1,781 participants. Safety, immunogenicity and effectiveness of Gardasil were assessed following vaccination in this population as they got older and as some became sexually active. Results also showed persistence of high immune response to HPV types 6, 11, 16 or 18 over 8 years in study participants. In this follow up period there were no cases of disease related to vaccine HPV types 6, 11, 16 or 18 through 8 years. This study will continue to follow participants through at least 10 years of post-vaccination follow-up.

References:

1.Krüger Kjær Set al.Long-term effectiveness of Gardasil™ in the Nordic countries. Poster and abstract presented th at the 28 International Papillomavirus Conference, Puerto Rico,Nov 30- Dec 6 2012. 2.Saah Aet al.Poster and abstractLong-term extension study of Gardasil in adolescents; results through month 96. th presented at the 28 International Papillomavirus Conference, Puerto Rico,Nov 30- Dec 6 2012. 3.Nygård Met al. A long term follow-up study of the immunogenicity of the quadrivalent HPV (qHPV) vaccine in th Scandinavia and Iceland. Poster and abstract presented at the 28 International Papillomavirus Conference, Puerto Rico,Nov 30- Dec 6 2012. About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as

MSD outside the USA and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is the only com pany in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines for Europe to improve the acceptability, efficacy and tolerability of vaccination.

For further information please contact:

Caroline ASHE Senior Director External Communications Europe Sanofi Pasteur MSD Tel : [phone] Mob : [phone] [e-mail]