Cervarix positive opinion
GlaxoSmithKline PLC
18 July 2007
FOR IMMEDIATE RELEASE: Wednesday 18th July 2007, London (UK) and Rixensart
(Belgium) - London Stock Exchange Announcement
GSK's Cervical Cancer Candidate Vaccine CervarixTM Receives Positive Opinion in
Europe for Prevention of Cervical Cancer
GlaxoSmithKline (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 date1, 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. 1
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. 2
Regulatory approvals and filings
Following its first licence in a major market granted by the Therapeutic Goods
Administration (TGA) of Australia, CervarixTM 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 GardasilTM. 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).
S M Bicknell
Company Secretary
18th July 2007
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.3 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. 4,5,6
Approximately 100 types of human papillomavirus have been identified to date
and, of these, approximately 15 virus types are considered to cause cervical
cancer. 7,8 Virus types 16 and 18 are responsible for approximately 71.5 per
cent of cervical cancers in Europe. 9
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 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.
Inquiries:
U.S. Media Inquiries: Liad Diamond (919) 483 2839
Nancy Pekarek (215) 751 7709
Alice Hunt (215) 751 7709
UK Media Inquiries: Philip Thomson (020) 8047 5502
Claire Brough (020) 8047 5502
Joss Mathieson (020) 8047 5502
US Analyst/ Investor Inquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
European Analyst/Investor Inquiries: Sally Ferguson (020) 8047 5543
David Mawdsley (020) 8047 5564
GSK Biologicals: Stella Gu (32) 2 656 3533
Chris Hunter-Ward (32) 2 656 3075
References
1. 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
2. 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
3. Ferlay J, Bray P, Pizani P, Parkin DM. Cancer incidence, mortality and
prevalence worldwide. Available at: GLOBOCAN 2002. Accessed September 20,
2005
4. Baseman J, Koutsky LA. The epidemiology of human papillomavirus
infections. Journal of Clinical Virology 2005; 32S; S16-S24
5. 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
6. 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
7. 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
8. de Villiers E, Fauquet C, Broker T, Bernard H, zur Hausen H.
Classification of papillomavirus. Virology 2004; 324: 17-27
9. 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
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