Reduction in Genital Warts Seen with Gardasil, New Studies are Early Markers of Impact

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1 NEWS RELEASE Reduction in Genital Warts Seen with Gardasil, New Studies are Early Markers of Impact New data presented at Eurogin show early benefits of HPV vaccination with Gardasil in Europe and confirm its good safety profile. Prague, July 10, 2012 Several important studies shared this week at the EUROGIN congress bring together new evidence of the effectiveness and safety of Gardasil in protecting people against HPVrelated illness, across national boundaries and over time. Three studies report on the work of European scientific teams which collaborated with local health care systems to study the impact of HPV vaccination in Germany, Belgium, and Sweden. These three studies provide independently similar results showing that HPV vaccination with Gardasil is effective in reducing the incidence of genital warts (GW) among young women. In parallel, two studies conducted in France and Sweden/Denmark also confirm Gardasil s good safety profile. Impact in preventing genital warts, an early marker of HPV-related disease. Gardasil directly targets the four types of HPV 6,11,16,18, which together cause the vast majority of HPV genital diseases. The impact of Gardasil in reducing genital warts is of importance in itself. But, since genital warts are the earliest HPV-related disease to develop following infection, these results can also serve as early markers of HPV vaccination s broader impact to come. Other diseases related to HPV, such as cervical cancer, take many years to develop, and since Gardasil has been available on the market for only six years, full real-world results of vaccination are expected only in the decade or two ahead. The new impact studies show that Gardasil is helping to reduce the number of young women diagnosed with genital warts: - A team from the German Institute for Epidemiology and Prevention (BIPS) found in a retrospective cohort study a1, that the incidence of genital warts in Germany decreased by 23% b in young girls of age 15 to 19 after the introduction of HPV vaccination. Slightly more than 30% of those years old in the study population 2 received in 2008 at least one vaccine dose. - In Belgium, a retrospective observational study 3c found that young women who had been vaccinated with Gardasil showed significantly reduced incidence of genital warts compared to those who had not been vaccinated at all or were vaccinated with the bivalent vaccine (which does not protect against genital warts). Women not vaccinated with Gardasil showed 8 times d more risk of getting genital warts than those vaccinated with Gardasil - In Sweden, a national population based cohort study e4 estimated that 4300 cases of GW were avoided each year between 2006 and 2010 as a result of HPV vaccination. Sweden has put in place opportunistic vaccination since 2006, resulting in vaccination of nearly women ( ). Sweden subsidizes vaccination of girls aged and the vaccination coverage in the subsidized group was 25-33% over that period. a data from one large health insurance company including nearly 7 million insured (around 8% of the German population). b p = c From 2007 onwards, women aged16-20 year- old were retrieved, of whom were vaccinated with qhpv vaccine. d The cumulative incidence estimates of GW were significantly lower among women that were vaccinated with qhpv vaccine compared to those that were not: 0.12% ( ) vs 0.93% ( ), p< e National population- based cohort of over 2.2 million women aged living in Sweden between 2006 and Incidence rates among vaccinated and unvaccinated women were calculated with an average follow- up time of 4.4 (SD ± 1.3) years.

2 The findings add new evidence to results observed in recent years in Australia where genital warts incidence in girls and young women f decreased by 59% 2 years after the launch of a HPV vaccination program g5. In the Melbourne area, cases of genital warts have nearly disappeared in young women only 4 years after the start of a vaccination program h6. Safety observations In addition to these impact studies, scientific teams are presenting two significant pieces of work confirming Gardasil s good safety profile: - The largest-to-date i HPV safety study performed in Sweden and Denmark 7 has illustrated that no increase in risks for autoimmune, neurologic or thromboembolic events for quadrivalent HPV vaccinated women were observed. - An observational study 8 in France j further corroborate these results and those released end of 2011 by the French Health Authority 9, observing no increased risk of autoimmune diseases associated with Gardasil vaccination. Before these studies, the clinical development for Gardasil included more than 25,000 adolescents and adults in nearly 40 countries. During the clinical development and since its first day on the market, the safety and effectiveness of vaccination with Gardasil have been under continuous analysis; adding up to more than 10 years of research conducted around the world 10. Taken altogether, these recent studies on Gardasil continue to demonstrate that across geographical boundaries and broad populations, HPV vaccination with Gardasil is well-tolerated and effective. Gardasil is the only quadrivalent vaccine against HPV 6,11,16 and 18, indicated for use from the age of 9 years for the prevention of premalignant genital lesions (cervical, vulvar an vaginal) and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types; and genital warts (condyloma acuminata) causally related to specific HPV types 11. These four HPV types are responsible for the large majority of genital diseases linked to HPV 12. More than 87 million doses of Gardasil have been distributed globally, with 20 million in Western Europe. 13 For more information about HPV or Gardasil contact: Caroline Ashe Senior Director External Communications Europe Sanofi Pasteur MSD 8, rue Jonas Salk Lyon Cedex 07 - France Tel : Mob : CAshe@spmsd.com f Observed in young Australian female resident under age 26 between 2005 and No significant decline was noted in female non- residents, women older than 26 years in July, 2007, or in men who have sex with men. g Australia provided free quadrivalent HPV vaccine to years- old girls in a schools- based programme from April 2007, and to resident women aged 26 years and younger through general practices from July One- dose coverage rates in Victoria, Australia, were estimated at 80% for girls aged 12 to 17 years in the schools- based programme and 58% for women aged 15 to 26 years in the adult catch- up programme. In total, eight clinical sites around Australia were recruited. h From July 2004 to June 2011, 52,454 new patients were seen at Melbourne Sexual Health Centre and 5,021 were diagnosed with GW. From July 2004 to June 2007 the proportions with GW either increased of remained the same. Comparing 2007/2008 and 2010/2011, GW declined in women under 21 years from 18.6% to 1.9%. i A cohort of 954,182 Danish and Swedish women aged years, of which 301,366 were vaccinated with qhpv vaccine, were followed for adverse events during October 2006 to December 2011 (Denmark) or December 2009 (Sweden). j Between December 2007 and April 2011, 113 specialist centers recruited 248 definite cases of autoimmune diseases (Ads) which were matched to 1001 controls. The proportion of cases (in females years- old) and controls vaccinated with Gardasil was 10.5% and 23.2% respectively, within predefined time windows up to 24 months before the index date (odds ratio adjusted for potential confounders 0.72, 95% confidence interval 0.45, 1.18).

3 Notes to Editors About HPV Human Papillomavirus (HPV) is a very common family of viruses, which are highly contagious. Close to 80% of sexually active adults will be infected with HPV in their lifetime, with the highest risk of exposure during adolescence and early adulthood 14,15. The infection is usually silent with no symptoms 16. People infected with HPV are often unaware of their infection 17,18. Most of the time, the immune system clears the HPV virus from the body naturally within two years. HPV-6, 11, 16 and 18 are the four most common HPV types and altogether cause the vast majority of HPVrelated genital diseases in Europe 12. HPV-related anogenital diseases While HPV is well-known for causing cervical cancer, HPV may affect other areas of the body than the cervix such as the vagina 19, the vulva 19, the anuserreur! Signet non défini. 9 and the penis 20. HPV and Genital Warts There are an estimated 720,000 to 790,000 new cases of genital warts in both sexes in Europe k each year 21. Around 90% of all cases of genital warts are caused by two strains of the virus, type 6 and type Reductions in genital warts cases at a population level can serve as early markers of the overall impact of HPV vaccination, since this disease appears earlier than HPV-related cancers. Current Indication for Gardasil in the European Union Gardasil is a quadrivalent vaccine, indicated for use from the age of 9 years for the prevention of: Ø Premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types Ø Genital warts (condyloma acuminate) causally related to specific HPV types. See sections 4.4 and 5.1 of the Summary of Product Characteristics for important information on the data that support this indication. The full Summary of Product Characteristics can be found at the EMA Web Site 23. The use of Gardasil should be in accordance with official recommendations. More than 87 million doses of Gardasil have been distributed globally, with 20 million in Western Europe without major safety incident. 13 About Eurogin 2012 Eurogin is the first and leading European-wide conference dedicated to HPV-related diseases. This week marks Eurogin s annual gathering of leading experts in the field developing a full review of current scientific developments in the field of cervical cancer and Human Papillomavirus-related diseases, raising the public health profile and increasing the need for responsive health services in this area. About Sanofi Pasteur MSD Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi, 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. k Europe = EU 27 except Greece, Hungary, Luxemburg, and Romania plus Iceland, Norway and Switzerland et calculation based on German and UK data and population data obtained from Eurostat

4 References 1 Mikolajczyk, R.T et al. The incidence of anogenital warts in Germany after introduction of HPV vaccination- EUROGIN 2012, Prague, Czech Republic,8-11 th July 2012 (abstract) 2 Horn J. et al- Health Care Databases- A tool to study population effects of HPV vaccination: assessment of HPV vaccination in German Health Insurance data. EUROGIN 2012, Prague, Czech Republic,8-11 th July 2012 (abstract) 3 Van Tielen R. Gobbo C. Monitoring the early impact of young girls quadrivalent HPV vaccination on genital warts in Belgium. EUROGIN 2012, Prague, Czech Republic,8-11 th July 2012 (abstract) 4 Leval, A et al. Quadrivalent HPV- Vaccine Population Effectiveness on genital warts: a population- based study in over 2.2 million women. - EUROGIN 2012, Prague, Czech Republic,8-11 th July 2012 (abstract) 5 Donovan, B et al. Quadrivalent human papillomavirus vaccination and trends in genital warts in Australia: analysis of national sentinel surveillance data, Lancet Infect Dis 2011;11: Read TR 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: Arnheim- Dahlström, L. et al. Occurrence of adverse events after quadrivalent HPV vaccination in Denmark and Sweden, Karolinska Institutet, Stockholm and Statens Seruminstitut, Copenhagen- EUROGIN 2012, Prague, Czech Republic,8-11 th July 2012 (abstract) 8 Grimaldi- Bensouda, L et al. Gardasil and autoimmune disorders: safety assessement using the PGRX information system. EUROGIN 2012, Prague, Czech Republic,8-11 th July 2012 (abstract) 9 ANSM.Cohort Study conducted by Afssaps based on SNIIRAM data preliminary results Update of november 10, Website ansm.fr. HPV_Etude+de+cohorte+_ pdf last accessed July 06, FDA Approval letter - June, last accessed June 15, Gardasil. Summary of Product characteristics Bonanni P et al. An Overview on the implementation of HPV vaccination in Europe. Hum Vaccin 2011;7: SPMSD Internal Data Syrjänen K et al. Prevalence, incidence and estimated life- time risk of cervical human papillomavirus infections in a nonselected finnish female population. Sex Transm Dis 1990;17[1]: Sellors JW. et al. Incidence, clearance and predictors of human papillomavirus in women. CMAJ 2003; 168: Centers for Disease Control and Prevention Website. Genital HPV Infection - Fact Sheet. hpv.htm/hpv- Factsheet (accessed June 21,2012) 17 Gerend MA, Magloire ZF. Awareness, knowledge and beliefs about Human Papillomavirus in a racially diverse sample of young adults. J Ado Health 2008;42: Rodriguez MC. Is Increasing HPV Infection Awareness Promoting Increased Vaccine Compliance? Internet J Adv Nurs Pract2010;11(1): De Vuyst H et al. Prevalence and type distribution of human papillomavirus in carcinoma and intraepithelial neoplasia of the vulva, vagina and anus: a meta- analysis. Int J Cancer 2009;124(7):

5 20 Miralles- Guri C et al. Human papillomavirus prevalence and type distribution in penile carcinoma. J Clin Pathol 2009;62(10): Hartwig 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;20[1]: Aubin F and Al. Human Papillomavirus Genotype Distribution in External Acuminata Condylomata: A Large French National Study (EDiTH IV). Clin Infect Dis 2008; 47: _Summary_for_the_public/human/000703/WC pdf