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Sanofi Pasteur (SASY.PA) Release: Gardasil® Approved In The European Union For A 2-Dose Schedule In Children Aged From 9 To 13 Years


4/7/2014 3:11:39 PM

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A new 2-dose regimen for Gardasil®, quadrivalent HPV vaccine, now available for adolescents

Lyon, France – April 7th 2014 - Sanofi Pasteur MSD announced today that the European Commission has granted marketing authorization for its quadrivalent Human Papillomavirus (HPV) vaccine, Gardasil®, for a 2-dose schedule at 0 and 6 months in children aged from 9 to 13 years.

"We are delighted to be able to offer this new, 2-dose schedule. It is based on data showing that 2 doses elicited a immune response in adolescents comparable to that of 3 doses in young women to the four HPV types – 6, 11, 16 and 18 – included in Gardasil®", said Dr Stephen Lockhart Vice President, Development of Sanofi Pasteur MSD. "These results are sustained 3 years after vaccination, which indicates that a 2 dose 0-6 month schedule of Gardasil®, is able to induce high antibody levels for protection against HPV-diseases. " concluded Dr Lockhart.

The approval of this new schedule for Gardasil® follows the positive opinion from the European Medicines Agency (EMA) granted in February, based on a Canadian study performed by Dobson et al. It demonstrates that the 2-dose 0, 6 month schedule in 9-13 year old girls elicited an immune response comparable/non-inferior to that of 3 doses in the 16-26 year old women, the population where quadrivalent vaccine efficacy has been shown. These results were sustained at 36 months of follow-up. 1*

Adolescents aged 14 years and above should still receive 3 doses at 0, 2 and 6 months. For children aged 9 to 13 years, the 3-dose schedule can alternatively be given, in accordance with national recommendations and immunisation programmes currently in use. 2

Gardasil® is the only quadrivalent HPV vaccine indicated in adolescent girls and boys to help protect against cervical cancer, vulvar and vaginal precancers as well as genital warts.1

Data recently published from a study in Australia showed the rapid impact of Gardasil® on disease in the real-world setting, with a strong reduction in high grade pre-cancerous cervical lesions in young women at population level. 3 Australian national vaccination programmes with Gardasil® also resulted in the near disappearance of genital warts in Melbourne area in women under 21 years of age. 4

To date, more than 29 Million doses of Gardasil® have been distributed in Western Europe, helping to protect futures of millions of adolescents. 5

Gardasil® is indicated in girls and boys from 9 years of age for the prevention of premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types as well as genital warts (condyloma acuminata) causally related to specific HPV types. # # #

*the duration of protection of a 2-dose schedule has not been established.

About Gardasil®
Gardasil® is a quadrivalent vaccine for protection against cancer of the cervix and other genital diseases caused by the human papillomavirus types 6, 11, 16 and 18: precancerous lesions of the cervix (CIN2/3), precancerous lesions of the vulva (VIN2/3) and vaginal (VaIN2/3) and genital warts (condyloma acuminata). Data published since Gardasil® came on the market have confirmed the positive impact of this vaccine on the prevention of genital diseases caused by human papillomavirus types 6, 11, 16 and 18.
Launched in 2006 and manufactured by Merck, it is the most widely used HPV vaccine worldwide with approximately 144 million doses distributed globally to date.

About HPV
In a study of 26 European countries, HPV types 16 and 18 were estimated to result in around 48,000 new cancer cases every year. 3 Genital warts are widespread in young adults, and their incidence in many European countries is increasing. 7,8 Although genital warts are not life-threatening, their treatment is long, painful and often unsatisfactory, with high recurrence rates. 6 Genital warts can also have a significant psychosocial impact – causing feelings of anxiety, depression, anger, shame and embarrassment. 7

About Sanofi Pasteur MSD www.spmsd.com

Sanofi Pasteur MSD is a European joint venture formed between Sanofi Pasteur (the vaccine division of Sanofi) and Merck (known as MSD outside the United States and Canada). Combining innovation and expertise, Sanofi Pasteur MSD is the only European pharmaceutical company dedicated exclusively to the distribution of vaccines. Sanofi Pasteur MSD makes use of the combined expertise resulting from Sanofi Pasteur and Merck’s research to focus on the development of new vaccines in Europe in order to produce the most effective, most acceptable and better tolerated vaccines.

For further information please contact:

Sanofi Pasteur MSD
Sylvia Martin-Jarrand
Tel : +33 4 37 28 40 55
Mob : +33 6 33 46 1365
smartin-jarrand@spmsd.com

1- Dobson SR, McNeil S, Dionne M, Dawar M, Ogilvie G, Krajden M, et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women. JAMA 2013;309(17):1793-802
2- Gardasil® Summary of Product Characteristics.
3- Crowe E et al. Effectiveness of quadrivalent human papillomavirus vaccine for the prevention of cervical abnormalities: case-control study nested within a population based screening programme in Australia. BMJ 2014;348:g1458 doi
4- Read et al. The near disappearance of genital warts in young women 4 years after commencing a national human papillomavirus (HPV) vaccination programme; Sex Transm Infect. 2011 Dec;87(7):544-7
5- SPMSD internal data. 2014
6- Hartwig S et al. Estimation of the epidemiological burden of human papillomavirus-related cancers and non-malignant diseases in men in Europe: a review. BMC Cancer 2012;12:30.
7- Dominiak-Felden G et al. Impact of human papillomavirus-related genital diseases on quality of life and psychosocial wellbeing: results of an observational, health-related quality of life study in the UK. BMC Public Health 2013;13:1065.
8-Patel H et al. Systematic review of the incidence and prevalence of genital warts. BMC Infect Dis 2013;13:39.

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