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Gardasil® approved in the European Union for a 2-dose schedule in children aged from 9 to 13 years

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.

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*the duration of protection of a 2-dose schedule has not been established
CO01039

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.

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Download the full release here. 

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.

In News

Sanofi Pasteur MSD Moves into new European Headquarters in Lyon, France

March 17, 2014, Lyon, France.

On March 17, 2014, Sanofi Pasteur MSD (SPMSD), the only company exclusively dedicated to vaccines for Europe, moved its corporate headquarters to the new “Ambre” building in Lyon, France, located at 162 avenue Jean-Jaures, in the city’s 7th arrondissement.

The move comes during a milestone year for the company, which marks its 20th anniversary in 2014, as well.  SPMSD was created in 1994 out of a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as MSD outside North America.

The move strongly supports the company’s development.  Previously spread across three different buildings, all corporate teams will now work under one roof.  Corporate teams focus on pan-European activities and serve as the central nervous system for 19 national affiliates operating across Europe.

SPMSD professionals work in close networks in order to develop and deliver vaccines that meet the unique needs of European populations.  Ambre’s configurations and state-of-the-art workplace tools will further facilitate new levels of collaboration amongst the teams.

“We’re thrilled to start leveraging everything that these new offices have to offer,” notes Jean-Paul Kress, President of Sanofi Pasteur MSD.  “The space will further facilitate our ability to seamlessly work together across functions and geographies in support of our unique European-focused mission.”

The new location is just a few kilometers from the company’s original home at 8 rue Jonas Salk.  It keeps the teams squarely at the heart of Lyon’s Gerland “Biopole” district, in close proximity to external collaborations essential to continued long-term development in France’s leading bio-scientific industries.

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 company 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.

Download the full announcement here

In News

Gardasil®: New 2-dose schedule granted positive CHMP opinion for Europe’s leading HPV vaccine

European Committee for Medicinal Products for Human Use evaluated positively a 2-dose schedule for Gardasil® in adolescents 

Lyon, France – February, 27  2014 – Sanofi Pasteur MSD announced today that its quadrivalent HPV vaccine, Gardasil® has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the use of a two-dose schedule in 9 to and including 13 year old adolescent girls and boys.

We are delighted of the CHMP’s positive opinion, said Dr Benoit Soubeyrand, Director, Medical Affairs Europe for Sanofi Pasteur MSD “and we are very proud to be able to propose a simplification of the dosing regimen of this important vaccine, which may enable better vaccine coverage in adolescent girls and boys.”

The  European licence application is supported by the results of a study performed in Canada by Dobson et al. (1) It demonstrates that antibody levels 1 month after a 2 dose schedule (0,6 months) of Gardasil in 243 girls 9-13 years old are non-inferior to the ones observed 1 month after a 3-dose schedule (0, 2, 6 months) in 272 16-26 years old women, population in which efficacy has been demonstrated.

A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, but does not always result in marketing authorisation.

Gardasil is the only quadrivalent HPV vaccine, helping to protect people from cervical cancer, genital precancerous lesions and genital warts, with demonstrated protection in real-life (2, 3, 4). It is the Europe’s leading HPV vaccine with 29 million doses distributed in Western Europe and approximately 144 million doses distributed worldwide.

Gardasil is currently licensed as a 3 dose vaccination schedule at 0, 2, 6 months in both girls and boys from the age of 9 years, for the prevention of premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types and genital warts (condyloma acuminata) causally related to specific HPV types.(5)

# # #

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 2006, it is the most widely used HPV vaccine worldwide with approximately 144 million doses distributed to date.

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 development 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.

- END -

For further information please contact:

Sylvia Martin-Jarrand

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

Download a copy of this release here. 

(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)    Brotherton JML et al. Early effect of the HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study. Lancet 2011;377:2085-92.

(3)    Read TRh 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; 87: 544-547.

(4)    Markowitz LE et al. Reduction in Human Papillomavirus (HPV) Prevalence Among YoungWomen Following HPV Vaccine Introduction in the United States, National Health and Nutrition Examination Surveys, 2003–2010. JID, 2013; 208[3], 385-393.

(5)    Gardasil SmPC