Gardasil®: New 2-dose Schedule Granted Positive CHMP Opinion for Europe's Leading HPV Vaccine

Lyon, France (ots/PRNewswire) -

European Committee for Medicinal Products for Human Use evaluated
positively

a 2-dose schedule for Gardasil(R) in adolescents

Sanofi Pasteur MSD announced today that its quadrivalent HPV
vaccine, Gardasil(R) has received a positive opinion from the
European Medicines Agency's Committee for Medicinal Products for
Human Use (CHMP) for the use of a two-dose schedule in 9 to and
including 13 year old adolescent girls and boys.

"We are delighted of the CHMP's positive opinion, said Dr Benoit
Soubeyrand, Director, Medical Affairs Europe for Sanofi Pasteur MSD
"and we are very proud to be able to propose a simplification of the
dosing regimen of this important vaccine, which may enable better
vaccine coverage in adolescent girls and boys."

The European licence application is supported by the results of a
study performed in Canada by Dobson et al. [(1)] It demonstrates that
antibody levels 1 month after a 2 dose schedule (0,6 months) of
Gardasil in 243 girls 9-13 years old are non-inferior to the ones
observed 1 month after a 3-dose schedule (0, 2, 6 months) in 272
16-26 years old women, population in which efficacy has been
demonstrated.

A CHMP positive opinion is one of the final steps before marketing
authorisation is granted by the European Commission, but does not
always result in marketing authorisation.

Gardasil is the only quadrivalent HPV vaccine, helping to protect
people from cervical cancer, genital precancerous lesions and genital
warts, with demonstrated protection in real-life [(2],[3],[4)]. It is
the Europe's leading HPV vaccine with 29 million doses distributed in
Western Europe and approximately 144 million doses distributed
worldwide.

Gardasil is currently licensed as a 3 dose vaccination schedule at
0, 2, 6 months in both girls and boys from the age of 9 years, for
the prevention of premalignant genital lesions (cervical, vulvar and
vaginal) and cervical cancer causally related to certain oncogenic
Human Papillomavirus (HPV) types and genital warts (condyloma
acuminata) causally related to specific HPV types.[(5)]

About Gardasil(R)

Gardasil(R) 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(R) 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 2006, it is the most widely used HPV vaccine worldwide
with approximately 144 million doses distributed to date.

About Sanofi Pasteur MSD http://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.

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) Brotherton JML et al. Early effect of the HPV vaccination programme on
cervical abnormalities in Victoria, Australia: an ecological study. Lancet
2011;377:2085-92.
3) Read TRh 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: 544-547.
4) Markowitz LE et al. Reduction in Human Papillomavirus (HPV) Prevalence Among
YoungWomen Following HPV Vaccine Introduction in the United States, National Health
and Nutrition Examination Surveys, 2003-2010. JID, 2013; 208[3], 385-393.
5) Gardasil SmPC

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

Contact:
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.