LONDON and RIXENSART, Belgium, July 18 /PRNewswire-FirstCall/ --
GlaxoSmithKline (NYSE: GSK) today announced that its cervical cancer
candidate vaccine received a positive opinion from the European Committee
for Human Medicinal Products (CHMP) for the prevention of precancerous
lesions (high grade cervical intraepithelial neoplasia - CIN grades 2 and
3) and cervical cancer causally related to human papillomavirus types 16
and 18. This proposed indication is based on data generated in girls and
women aged between 10 and 25.
The positive opinion was reached after the CHMP reviewed data from
clinical trials in almost 30,000 females, including data from the largest
Phase III cervical cancer vaccine efficacy trial to date, which
demonstrated that the candidate vaccine showed an excellent efficacy
profile and was generally well tolerated.
"Today's positive opinion from the CHMP is great news for women across
Europe. It is a significant step towards achieving our ambition -- to
provide women with protection against cervical cancer. Coupled with the
excellent clinical trial results published recently, this news is further
evidence of the great potential of our cervical cancer candidate vaccine,"
said JP Garnier, Chief Executive Officer of GSK.
The GSK cervical cancer candidate vaccine will now be proposed for
final approval by the European Commission and a Marketing Authorisation
could be granted in the coming months.
To date, over 40,000 women have participated or are currently taking
part in clinical trials to evaluate the efficacy and immunogenicity of
GSK's cervical cancer candidate vaccine. In completed clinical trials,
GSK's cervical cancer candidate vaccine has been shown to be generally
well- tolerated.(i)
Novel adjuvant system
GSK's cervical cancer candidate vaccine is formulated with a novel
proprietary adjuvant system called AS04, which is designed to enhance the
immune response and increase the duration of protection against
cancer-causing virus types. Duration of protection is particularly
important as women may acquire infections throughout their lifetimes.
Published data have shown that the vaccine formulated with this adjuvant
system induces an immune response of higher magnitude and persistence
compared to a GSK vaccine formulated with conventional aluminum hydroxide
adjuvant alone.(ii)
Regulatory approvals and filings
Following its first license in a major market granted by the
Therapeutic Goods Administration (TGA) of Australia, Cervarix(TM) is now
available in Australia for the prevention of cervical cancer and
precancerous lesions caused by human papillomavirus types 16 and 18 for use
in females age 10 to 45 years.
GSK submitted a Biologics License Application (BLA) to the U.S. Food
and Drug Administration (FDA) for GSK's cervical cancer candidate vaccine
in March 2007, following earlier regulatory filings in Africa, Asia and
Latin America.
Ongoing studies
Several clinical studies of GSK's cervical cancer candidate vaccine are
ongoing and GSK expects to file additional data with regulatory authorities
as these studies are completed. In January 2007, GSK announced that it had
initiated the first study of its kind designed to compare the
immunogenicity of its cervical cancer candidate vaccine, versus
Gardasil(TM). The primary objective of the head-to-head trial is to compare
the immune responses to cancer-causing virus types 16 and 18 in U.S. women
18 to 26-years-old. Secondary objectives include evaluating the immune
responses to virus types 16 and 18 in women 27 to 35-years-old and 36 to
45-years-old. In addition, the study will compare immune responses to other
cancer-causing virus types. Results are expected 12 months after patient
enrollment is complete, with extended follow up continuing for
approximately 17 months after the last study visit (month 7 through to
month 24).
Notes to Editors
About cervical cancer
Cervical cancer is the second leading cause of cancer in women under
45, and causes over 270,000 deaths worldwide per year.(iii) It occurs when
infection with the human papillomavirus becomes persistent, and progresses
to cancer. Up to 80 per cent of sexually active women will acquire a human
papillomavirus infection in their lifetime, with the risk of persistence
increasing with age.(iv, v, vi) Approximately 100 types of human
papillomavirus have been identified to date and, of these, approximately 15
virus types are considered to cause cervical cancer.(vii, viii) Virus types
16 and 18 are responsible for approximately 71.5 per cent of cervical
cancers in Europe.(ix)
About GlaxoSmithKline and GlaxoSmithKline Biologicals
In the next five years, GSK expects to launch more major new vaccines:
a vaccine to prevent pneumococcal disease, an improved flu vaccine for the
elderly, and a meningitis combination vaccine for infants.
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, please visit http://www.gsk.com/media.
GSK Biologicals (GSK Bio), one of the world's leading vaccine
manufacturers, is headquartered in Rixensart, Belgium, where the majority
of GlaxoSmithKline's activities in the field of vaccine research,
development and production are conducted. GSK Bio employs more than 1,500
scientists, who are devoted to discovering new vaccines and developing more
cost-effective and convenient combination products to prevent infections
that cause serious medical problems worldwide. In 2006, GSK Bio distributed
more than 1.1 billion doses of vaccines to 169 countries in both the
developed and the developing world -- an average of 3 million doses a day.
Of those vaccine doses, approximately 136 million were doses of combination
paediatric vaccines which protect the world's children from up to six
diseases in one vaccine.
Cervarix is a trademark of the GlaxoSmithKline group of companies.
Gardasil is a trade mark of Merck & Co Inc.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, the company cautions investors that any
forward-looking statements or projections made by the company, including
those made in this announcement, are subject to risks and uncertainties
that may cause actual results to differ materially from those projected.
Factors that may affect the Group's operations are described under 'Risk
Factors' in the Operating and Financial Review and Prospects in the
company's Annual Report on Form 20-F for 2006.
References
(i) Paavonen, J., Jenkins, D., Bosch, X., et al. Efficacy of a human
papillomavirus (HPV)-16/18 L1 virus-like particle (VLP) AS04 vaccine: a
phase III randomized, controlled trial in young women. The Lancet 2007;
369: 2161- 2170
(ii) Giannini SL, et al. Enhanced humoral and memory B cellular
immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminum
salt combination (AS04) compared to aluminium salt only. Vaccine 2006 24:
5937-5949
(iii) Ferlay J, Bray P, Pizani P, Parkin DM. Cancer incidence,
mortality and prevalence worldwide. Available at: GLOBOCAN 2002. Accessed
September 20, 2005
(iv) Baseman J, Koutsky LA. The epidemiology of human papillomavirus
infections. Journal of Clinical Virology 2005; 32S; S16-S24
(v) Brown DR, Shew ML, Qadadri B, Neptune N, Vargas M, Tu W, Juliar BE,
Breen TE, Fortenberry JD. A longitudinal study of genital human
papillomavirus infection in a cohort of closely followed adolescent women.
Journal Infectious Diseases 2005; 191: 182-192
(vi) Castle PE, Schiffman M et al. A prospective study of age trends in
cervical human papillomavirus acquisition and persistence in Guanacaste,
Costa Rica. Journal of Infectious Diseases 2005; 191; 1808-1816
(vii) Munoz N, Bosch FX, de Sanjose S, et al. Epidemiologic
classification of human papillomavirus types associated with cervical
cancer. New England Journal of Medicine 2003; 348: 518-527
(viii) de Villiers E, Fauquet C, Broker T, Bernard H, zur Hausen H.
Classification of papillomavirus. Virology 2004; 324: 17-27
(ix) Munoz N, Bosch FX, Castellsague X, Diaz M, de Sanjose S, Hammouda
D, Shah KV, Meijer CJLM. Against which human papillomavirus types shall we
vaccinate and screen? The international perspective. International Journal
of Cancer 2004; 111: 278-285
SOURCE GlaxoSmithKline
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