19th Jul 2007 07:00
GlaxoSmithKline PLC18 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 vaccinereceived a positive opinion from the European Committee for Human MedicinalProducts (CHMP) for the prevention of precancerous lesions (high grade cervicalintraepithelial neoplasia - CIN grades 2 and 3) and cervical cancer causallyrelated to human papillomavirus types 16 and 18. This proposed indication isbased on data generated in girls and women aged between 10 and 25. The positive opinion was reached after the CHMP reviewed data from clinicaltrials in almost 30,000 females, including data from the largest Phase IIIcervical cancer vaccine efficacy trial to date1, which demonstrated that thecandidate vaccine showed an excellent efficacy profile and was generally welltolerated. "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 withprotection against cervical cancer. Coupled with the excellent clinical trialresults published recently, this news is further evidence of the great potentialof our cervical cancer candidate vaccine," said JP Garnier, Chief ExecutiveOfficer of GSK. The GSK cervical cancer candidate vaccine will now be proposed for finalapproval by the European Commission and a Marketing Authorisation could begranted in the coming months. To date, over 40,000 women have participated or are currently taking part inclinical trials to evaluate the efficacy and immunogenicity of GSK's cervicalcancer candidate vaccine. In completed clinical trials, GSK's cervical cancercandidate vaccine has been shown to be generally well-tolerated. 1 Novel adjuvant system GSK's cervical cancer candidate vaccine is formulated with a novel proprietaryadjuvant system called AS04, which is designed to enhance the immune responseand increase the duration of protection against cancer-causing virus types.Duration of protection is particularly important as women may acquire infectionsthroughout their lifetimes. Published data have shown that the vaccineformulated with this adjuvant system induces an immune response of highermagnitude and persistence compared to a GSK vaccine formulated with conventionalaluminum hydroxide adjuvant alone. 2 Regulatory approvals and filings Following its first licence in a major market granted by the Therapeutic GoodsAdministration (TGA) of Australia, CervarixTM is now available in Australia forthe prevention of cervical cancer and precancerous lesions caused by humanpapillomavirus 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 DrugAdministration (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 ongoingand GSK expects to file additional data with regulatory authorities as thesestudies are completed. In January 2007, GSK announced that it had initiated thefirst study of its kind designed to compare the immunogenicity of its cervicalcancer candidate vaccine, versus GardasilTM. The primary objective of thehead-to-head trial is to compare the immune responses to cancer-causing virustypes 16 and 18 in U.S. women 18 to 26-years-old. Secondary objectives includeevaluating the immune responses to virus types 16 and 18 in women 27 to35-years-old and 36 to 45-years-old. In addition, the study will compare immuneresponses to other cancer-causing virus types. Results are expected 12 monthsafter patient enrollment is complete, with extended follow up continuing forapproximately 17 months after the last study visit (month 7 through to month24). S M BicknellCompany Secretary18th July 2007 Notes to Editors About cervical cancer Cervical cancer is the second leading cause of cancer in women under 45, andcauses over 270,000 deaths worldwide per year.3 It occurs when infection withthe human papillomavirus becomes persistent, and progresses to cancer. Up to 80per cent of sexually active women will acquire a human papillomavirus infectionin their lifetime, with the risk of persistence increasing with age. 4,5,6Approximately 100 types of human papillomavirus have been identified to dateand, of these, approximately 15 virus types are considered to cause cervicalcancer. 7,8 Virus types 16 and 18 are responsible for approximately 71.5 percent 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 vaccineto prevent pneumococcal disease, an improved flu vaccine for the elderly, and ameningitis combination vaccine for infants. GlaxoSmithKline - one of the world's leading research-based pharmaceutical andhealthcare companies - is committed to improving the quality of human life byenabling people to do more, feel better and live longer. For companyinformation, please visit www.gsk.com/media. GSK Biologicals (GSK Bio), one of the world's leading vaccine manufacturers, isheadquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline'sactivities in the field of vaccine research, development and production areconducted. GSK Bio employs more than 1,500 scientists, who are devoted todiscovering new vaccines and developing more cost-effective and convenientcombination products to prevent infections that cause serious medical problemsworldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccinesto 169 countries in both the developed and the developing world - an average of3 million doses a day. Of those vaccine doses, approximately 136 million weredoses of combination paediatric vaccines which protect the world's children fromup 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 LitigationReform Act of 1995, the company cautions investors that any forward-lookingstatements or projections made by the company, including those made in thisannouncement, are subject to risks and uncertainties that may cause actualresults to differ materially from those projected. Factors that may affect theGroup's operations are described under 'Risk Factors' in the Operating andFinancial Review and Prospects in the company's Annual Report on Form 20-F for2006. 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 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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