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.

ots Originaltext: Sanofi Pasteur MSD GmbH
Im Internet recherchierbar: http://www.presseportal.de

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