Sanofi Pasteur MSD GmbH

Pivotal Study of Investigational 9-Valent HPV Vaccine Demonstrates Additional Protection Against HPV-Related Disease

Lyon, France (ots/PRNewswire) - - New 9-valent HPV vaccine prevented 97% of cervical, vaginal and vulvar

pre-cancers caused by five additional HPV types

- Immunogenicity non-inferior to GARDASIL for original four HPV types

Lyon, 4 November 2013 - Sanofi Pasteur MSD reported today that Merck's investigational 9-valent Human Papilloma Virus (HPV) vaccine, V503, prevented approximately 97 percent of cervical, vaginal and vulvar pre-cancers caused by five additional HPV types in its pivotal Phase III efficacy study.

The study also showed that V503 generated immune responses to HPV types 6, 11, 16, and 18 that were non-inferior to those generated by Gardasil. The frequencies of adverse event reports were also generally comparable between V503 and Gardasil.

Merck's investigational 9-valent HPV vaccine includes five more HPV types (31, 33, 45, 52, 58) in addition to the four original HPV types in its Gardasil vaccine (6, 11, 16, 18). The vaccine is being developed to provide protection against 9 types of the HPV virus that are known to cause HPV related cervical/genital cancers. The vaccine's efficacy against these additional virus types is a major step in the battle against HPV-related disease.

"In the Phase III studies being presented for the first time, V503 prevented approximately 97 percent of high-grade cervical, vulvar and vaginal diseases caused by five additional HPV types," said study investigator Elmar Joura, M.D., Associate Professor of Gynecology and Obstetrics, Medical University of Vienna and Comprehensive Cancer Center, Vienna, Austria.

These data, along with results of two other Phase III studies, are being presented for the first time at the EUROGIN congress (European Research Organization on Genital Infection and Neoplasia) in Florence, Italy on Tuesday 5 November 2013.

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between Merck, known as MSD outside the USA and Canada and Sanofi Pasteur, the vaccine division of Sanofi. 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.

Editor's Notes

Results from the pivotal Phase III efficacy study (abstract #SS8-4)

The pivotal Phase III study evaluated the efficacy, safety and immunogenicity of V503 (n=7,099) compared to Gardasil (n=7,105) in 16-26 year old females who were not infected with the relevant HPV types at enrollment and who remained free of infection with the relevant HPV types through Month 7. All three doses of the vaccines were given within one year.

The results were as follows:

- 96.7% reduction in the combined incidence of high-grade
  cervical/vulvar/vaginal disease [CIN (cervical intraepithelial neoplasia) 2/3+, VIN
  (vulvar intraepithelial neoplasia) 2/3+, and VaIN (vaginal intraepithelial neoplasia)
  2/3+] caused by HPV types 31, 33, 45, 52, 58 (1 case in the group that received V503
  vs. 30 cases in the group that received Gardasil).
 
- 97.1% reduction in the combined incidence of cervical/vulvar/vaginal
  disease of any grade (all CIN, VIN, VaIN) caused by HPV types 31, 33, 45, 52, 58 (3
  cases in the group that received V503 vs. 103 cases in the group that received
  Gardasil).
 
- 96.0% efficacy against six-month persistent HPV infection with HPV types
  31, 33, 45, 52, 58 (35 cases in the group that received V503 vs. 810 cases in the
  group that received Gardasil).
 

Significance of non-inferiority outcome

Non-inferior immunogenicity for the four HPV types (6, 11, 16, 18) that are in V503 and in Gardasil was also a primary endpoint in this study. Because Gardasil has been shown in clinical studies to be highly effective against certain diseases caused by HPV types 6, 11, 16, and 18, few disease endpoints caused by these HPV types were expected, making it difficult to directly assess efficacy of V503 for these four types.

Therefore, antibody levels were evaluated for these four HPV types common to both vaccines. V503 generated immune responses for HPV 6, 11, 16, and 18 at Month 7 that were non-inferior to those generated by Gardasil. These results support bridging of the efficacy findings for Gardasil for HPV types 6, 11, 16, 18 to V503.

Contact:

For further information please contact: Caroline ASHE, Senior
Director External Communications Europe, Sanofi Pasteur MSD, Tel:
+33-4-37-28-4040, Mob: +33-6-33-46-1365, cashe@spmsd.com


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