Gardasil®: CHMP Grants Positive Opinion for New Indication, for the Prevention of Anal Cancers and Anal Precancerous Lesions,

Gardasil®: CHMP Grants Positive Opinion for New Indication, for the Prevention
     of Anal Cancers and Anal Precancerous Lesions, in the European Union

  PR Newswire

  LYON, France, April 30, 2014

LYON, France, April 30, 2014 /PRNewswire/ --

European Committee for Medicinal Products for Human Use evaluated positively a
new indication for the prevention of anal cancers and precancerous lesions for
                                 Gardasil® 

Sanofi Pasteur MSD announced today that the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) has given a positive
opinion for Gardasil ^® to be used for the prevention of anal precancerous
lesions and anal cancers, causally related to oncogenic Human Papillomavirus
(HPV) types 16 and 18.

This new indication is supported by the results of a study showing the high
efficacy of Gardasil ^® against anal precancerous lesions linked to HPV types
6, 11, 16 & 18 (AIN 2/3) which are recognized as immediate precursors of anal
cancers ^[ ^1 ^] ^. .

" Anal cancer is a rare but serious disease frequently caused by HPV and for
which there is no screening ," said Dr Jean-Paul Kress President of Sanofi
Pasteur MSD. " This new indication for the quadrivalent HPV vaccine offers for
the first time protection from this cancer thanks to a vaccine ."

A CHMP positive opinion is one of the final steps before a variation to the
marketing authorisation granted by the European Commission.

Gardasil ^® is a 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 Europe's
leading HPV vaccine with 29 million doses distributed in Western Europe and
approximately 144 million doses distributed worldwide. The number of doses
administered is not known.

Gardasil ^® is currently licensed from the age of nine 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 anal cancer 

Approximately 6,800 new cases of anal cancer are estimated to occur annually
in Europe*, among which about 75-80% are attributable to HPV types 16 and 18
^[ ^6 ^, ^7 ^, ^8 ^] . According to population-based studies, anal cancers
are more frequent in women than in men, with over 60% of cases occurring in
women ^[6] . In men, the incidence of anal cancer is higher among men who have
sex with men (MSM), however a population based study estimated that 53% of
male anal cancers in occurred in heterosexual men ^[ ^8 ^] .

The incidence of anal cancer has been continuously increasing over recent
decades, both amongst men and women, in industrialized countries in general,
and in Europe in particular ^[ ^8 ^] .

Prevention of anal cancer 

The efficacy of Gardasil ^® against anal disease - anal intraepithelial
neoplasia (AIN) and anal cancer - was evaluated in a population of 598 men who
have sex with men between 16 and 26 years of age. The primary analysis was
conducted in the per-protocol efficacy (PPE) population, which consisted of
individuals who received all three vaccinations within one year of enrolment,
did not have any major deviations from the study protocol, and were naïve to
HPV types 6, 11, 16 and 18 when they started the study and remained free of
infection from these four HPV types through one month after receiving their
last vaccine dose ^[ ^5 ^] .

The efficacy of Gardasil ^® in reducing the incidence of anal precancerous
lesions grades 2/3 (AIN 2/3) related to vaccine HPV types 6, 11, 16 & 18 was
74.9% (95 % CI: 8.8, 95.4) and 86.6% (95 % CI: 0.0, 99.7) for the anal
precancerous lesions grades 2/3 (AIN 2/3) related to the 2 oncogenic vaccine
HPV types 16 & 18 ^[ ^5 ^] . Median duration of follow-up was 2.15 years.

The CHMP acknowledged the extrapolation of the efficacy of Gardasil ^® in
preventing AIN 2/3 from the MSM population to healthy heterosexual men (HM)
and women.

About Gardasil ^® ^

Gardasil ^® , manufactured by Merck, 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).

Launched 2006, it is the most widely used HPV vaccine worldwide with
approximately 144 million doses distributed to date. The number of doses
administered is not known.

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.

*United Nations European Region

References

1.Scholefield JH, Castle MT, Watson NF. Malignant transformation of high
    grade anal intraepithelial neoplasia. Br J Surg 2005;92:1133-6.
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 Young Women Following HPV Vaccine Introduction in the United States,
    National Health and Nutrition Examination Surveys, 2003-2010. J Infect
    Dis, 2013; 208[3]: 385-393.
5.Gardasil SmPC, April 2014.
6.Forman D, de Martel C, Lacey CJ, Soerjomataram I, Lortet-Tieulent J, Bruni
    L, et al. Global burden of human papillomavirus and related diseases.
    Vaccine 2012;30 Suppl 5:F12-23.
7.de Martel C, Ferlay J, Franceschi S, Vignat J, Bray F, Forman D, et al.
    Global burden of cancers attributable to infections in 2008: a review and
    synthetic analysis. Lancet Oncol 2012;13(6):607-15.
8.De Vuyst H, Clifford GM, Nascimento MC, Madeleine MM, Franceschi S.
    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):1626-36.
9.Brewster DH, Bhatti LA. Increasing incidence of squamous cell carcinoma of
    the anus in Scotland, 1975-2002. Br J Cancer 2006;95(1):87-90.
10.Nielsen A, Munk C, Kjaer SK. Trends in incidence of anal cancer and
    high-grade anal intraepithelial neoplasia in Denmark, 1978-2008. Int J
    Cancer 2012;130(5):1168-73.
11.Daling JR, Madeleine MM, Johnson LG, Schwartz SM, Shera KA, Wurscher MA,
    et al. Human papillomavirus, smoking, and sexual practices in the etiology
    of anal cancer. Cancer 2004;101(2):270-80.
12.Brewster DH, Bhatti LA. Increasing incidence of squamous cell carcinoma
    of the anus in Scotland, 1975-2002. Br J Cancer 2006;95(1):87-90.
13.Robinson D, Coupland V, Moller H. An analysis of temporal and generational
    trends in the incidence of anal and other HPV-related cancers in Southeast
    England. Br J Cancer 2009;100(3):527-31.
14.Goldman S, Glimelius B, Nilsson B, Pahlman L. Incidence of anal epidermoid
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15.Nielsen A, Munk C, Kjaer SK. Trends in incidence of anal cancer and
    high-grade anal intraepithelial neoplasia in Denmark, 1978-2008. Int J
    Cancer 2012;130(5):1168-73.
16.van Lieshout A, Pronk A. [Increasing incidence of anal cancer in the
    Netherlands]. Ned Tijdschr Geneeskd 2010;154:A1163.

For further information please contact:

Sylvia Martin-Jarrand Sanofi Pasteur MSD Tel: +33-4-37-28-40-55 Mob:
+33-6-33-46-13-65 smartin-jarrand@spmsd.com
 
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