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Sanofi Pasteur MSD Welcomes Sweden's Decision to Recommend and FundHuman Papillomavirus Vaccination for School Girls

LYON, France, 27th February 2008 – Sanofi Pasteur MSD welcomes the decision by the health authorities in Sweden to recommend free vaccination of girls in school to protect them against cervical cancer and other human papillomavirus (HPV)-related genital diseases.
“This is great news for the girls in Sweden," comments Didier Hoch, president of Sanofi Pasteur MSD. "We hope that vaccination programmes will be implemented quickly, so girls women could soon have full access to these programmes that will help save lives and protect girls' and women's health from cervical cancer and other HPV-related genital diseases."

Yesterday, the Swedish National Board of Health and Welfare (Socialstyrelsen) recommended universal free vaccination of girls in school years five and six (aged 10-12 years) through the school health service. According to the administrative procedure in Sweden, this recommendation is now open for referral with final confirmation expected in April 2008 and implementation at county level from autumn 2008.

In May 2007, the Pharmaceutical Benefits Board in Sweden had included Gardasil® in the national Pharmaceutical Benefits Scheme for girls aged 13-17 years, marking the first time that the Board granted a vaccine reimbursement status.   The reimbursement enables catch up vaccination of girls aged 13-17 years in addition to the now recommended free routine vaccination girls aged 12 at school.

Thirteen Western European countries (Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxemburg, Norway, Portugal, Spain, Switzerland, and the United Kingdom) have already recommended routine human papillomavirus vaccination for pre-adolescents girls, often coupled with catch-up programmes for adolescent girls and young women. Similar recommendations were made in the United States, Canada and Australia

In eleven of these countries (Belgium, Denmark, France, Germany, Greece, Italy, Luxemburg, Portugal, Spain, Switzerland, and the United Kingdom), reimbursement or funding is already in place or has been announced for 2008.
Gardasil® is a quadrivalent (6,11,16,18) HPV vaccine that can help prevent cervical cancer and other HPV-related genital diseases, including precancerous cervical and vulvar lesions and genital warts caused by the virus types targeted by the vaccine.
Gardasil® has been approved in 93 countries worldwide and has met with great recognition from experts, health authorities and physicians. More than 20 million doses were distributed worldwide until the end of December 2007.

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Notes to editors
The burden of cervical cancer and other human papillomavirus diseases
Despite screening for early detection, cervical cancer remains the second most common cause of death from cancer (after breast cancer) among young women (15-44 years) in Europe .  Around 33,500 women are diagnosed with, and 15,000 women die from cervical cancer each year.
In addition, hundreds of thousands of women are diagnosed with other HPV-related genital diseases that start before the occurrence of cervical cancer and can touch other genital organs than the cervix. These diseases include pre-cancerous and early cervical lesions , , , vulvar and vaginal cancer , , , pre-cancerous vulvar and vaginal lesions , , ,  and genital warts. 
Early cervical lesions and genital warts in particular can occur much faster than cervical cancer, often within a few months after exposure to the virus.
It is estimated that types 6/11/16/18 cause 75% of cervical cancer in Europe  (types 16/18), 70% of vulvar and vaginal cancers, 70% of pre-cancerous(CIN2/3) and 35-50% of early cervical lesions (CIN1), 70% of pre-cancerous vulvar and vaginal lesions, and 90% of genital warts. , 
Virus types 6/11 cause 10% of early cervical lesions (~80,000 cases each year) in Europe in addition to the 25% of early cervical lesions caused by types 16 and 18 (~200,000)32, , ,  Virus types 6 /11 also cause 90% of genital warts (~225,000 cases)29,30,32, ,   
Though type 6/11-related early cervical lesions usually do not progress to cancer, screening cannot distinguish them from type 16/18-related which may progress to cancer. They require the same follow up  and may lead to the same anxiety in women.
Genital warts can cause anxiety which may impact personal relationships. Even if effective in the short term, physically ablative therapies are painful and recurrence rates can be high, as only the visible lesion is excised while the infection persists. , ,

Current EU indication of Gardasil®
Gardasil®, human papillomavirus vaccine [types 6,11,16,18] (recombinant, adsorbed), can be given to children and adolescents 9 to15 years and adult females 16 to 26 years of age and is indicated for the prevention of cervical carcinoma (cervical cancer), high grade cervical dysplasia CIN2/3 (precancerous cervical lesions), high grade vulvar dysplastic lesions VIN 2/3 (precancerous vulvar lesions) and external genital warts (condyloma acuminata) caused by human papillomavirus types 6, 11, 16 and 18.

About Sanofi Pasteur MSD
Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc. 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 & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.

Dr. Arne Näveke
Executive Director, Communication Europe
Sanofi Pasteur MSD
Tel +33 4 37 28 40 40, Fax +33 4 37 28 44 04


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Posted: February 2008