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Sanofi Pasteur MSD announces European regulatory submission for a 9-valent Human Papillomavirus Vaccine

On April 23, 2014, Sanofi Pasteur MSD announced that it has filed a marketing authorization application (MAA) to the European Medicine Agency (EMA) for its 9-valent human papillomavirus (HPV) vaccine.

The regulatory dossier is notably based on the results from the pivotal clinical trial P001 recently presented at EUROGIN congress (Florence, Italy, November 2013). The results showed that not only was the new vaccine as immunogenic as Gardasil® for protecting young adults and adolescents from HPV 6,11,16 and 18 but was also 97% effective at protecting against cervical, vaginal, and vulvar pre-cancerous lesions caused by 5 additional HPV types (31, 33, 45, 52, 58).

An application to market the 9 –valent papillomavirus vaccine in the United States is currently under review by the CBER / U.S. Food & Drug Administration.
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.

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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

In News

Sanofi Pasteur MSD welcomes European Immunization Week 2014

European vaccine leader hosts events across the region to help raise awareness of immunization throughout life

Lyon, France – April 22, 2014 – Sanofi Pasteur MSD welcomes the World Health Organization’s European Immunization Week 2014 (EIW 2014) with a series of awareness-raising events across the region, taking place between April 22nd and 26th. Sanofi Pasteur MSD, the European leader for vaccines in Europe, has joined forces with NGOs, health care professionals to help raise awareness of the important benefits of full vaccination throughout life.

The goal of European Immunization Week is to increase vaccination coverage. Each day of the week will focus on lifelong immunization from early childhood to adolescence through to adulthood and old age.

At Sanofi Pasteur MSD, many subsidiaries will roll-out external engagement initiatives to support EIW 2014 such as: a public awareness campaign involving major basketball clubs in Spain and a UNICEF-partnered media. An informational event in the UK for the public in partnership with top university experts and local lawmakers. A parent-focused breakfast in Portugal with opinion-leading bloggers and national pediatric health experts.

At Sanofi Pasteur MSD headquarters, an internal campaign will involve all employees in supporting the European Immunization Week 2014.

Vaccines are unquestionably one of the most cost-effective public health measures available”, says Dr Jean-Paul Kress, President of Sanofi Pasteur MSD. “Wide-spread vaccination has eradicated smallpox and made Europe polio-free”.

Groundbreaking innovative science has continued to offer us new vaccines that extend protection against infectious diseases in childhood and well beyond“, notes also Dr Kress. Raising awareness – thanks to European Immunization Week is an important step towards reaching European immunization goals,” concludes Dr Kress.

For further information about events on a national level across Europe, visit the WHO’s dedicated campaign website: http://eiw.euro.who.int.  Activities are timed to coincide with World-wide events as part of World Immunization Week, also led by the WHO: http://www.who.int/campaigns/immunization-week/2014/en/ .

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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.

About European Immunization Week eiw.euro.who.int

European Immunization Week (EIW) promotes the core message that the immunization of every child is vital to prevent diseases and protect life. The goal is to increase vaccination coverage by raising awareness of the importance of immunization.  “Immunization for life” will be the theme of EIW 2014, to take place from 22 to 26 April. Activities in the Region will focus on all age groups – reminding parents to vaccinate their children but also underlining the importance of maintaining personal protection from preventable diseases throughout the life course.

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For further information please contact:

Sanofi Pasteur MSD
Sylvia Martin-Jarrand
Tel : +33 4 37 28 40 55
Mob : +33 6 33 46 13 65
smartin-jarrand@spmsd.com

In News

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.