GSK Submits Cervarix™ Licence Application To Japan's Health Authorities

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 30 Sep 2007 - 0:00 PDT

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GlaxoSmithKline (GSK) announced that it has submitted a licence application for its cervical cancer candidate vaccine Cervarix™ to the Japanese Ministry of Health, Labor and Welfare (MHLW). This is the first vaccine for the prevention of cervical cancer to be filed for approval in Japan.

GSK's cervical cancer candidate vaccine is formulated with a novel proprietary adjuvant system called AS04, intended to enhance immune response and increase duration of protection. The licence applied for is for the prevention of cervical cancer and precancerous lesions associated with the most common cancer causing human papillomavirus types.

The incidence of cervical cancer in Japan is on the increase.[1] With 2,500 deaths[2] and 7,000 new cases diagnosed per year2, cervical cancer has become the most common cancer in Japanese women in their 20s and 30s and the second most common cancer in Japanese women overall.2

"With rising rates of cervical cancer, especially in younger Japanese women, Japanis a priority country for GSK's cervical cancer candidate vaccine, said Jean Stephenne, President and General Manager, GSK Biologicals.

"This filing submission includes a vast amount of data on the efficacy and safety of the candidate vaccine in Asian women. The submission follows other recent approvals across the Asia-Pacific region, and launches in Australiaand the Philippines. We look forward to the opportunity of ensuring that Japanese women will equally have access to our vaccine, for protection against this life-threatening disease."

The file submitted to the MHLW includes data from clinical trials in almost 30,000 females 10 to 55 years of age across four continents. The submission also included data from the largest Phase III cervical cancer vaccine efficacy trial to date[3],which demonstrated that GSK's cervical cancer candidate vaccine was highly efficacious and was generally well tolerated. A third of patients in this key trial were from Asia[4], which means that we have a very balanced population included in the trial.

Recent European marketing authorisation, granted on 21st September 2007, indicates GSK's cervical cancer candidate vaccine for the prevention of precancerous cervical lesions (high-grade cervical intraepithelial neoplasia [CIN] grades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.[5] The indication isbased on data generated in girls and women aged between 10 and 25.[6],[7]

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.

Published data have shown that the candidate vaccine, formulated with this adjuvant system, induces an immune response of higher magnitude and persistence compared to the same vaccine composition, formulated with conventional aluminium hydroxide adjuvant alone.[8]

About Cervarix™ regulatory progress

GSK's cervical cancer candidate vaccineis indicated in the EU for the prevention of high grade cervical intraepithelial neoplasia (CINgrades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.5

In May 2007, the candidate vaccine was granted its first license in a major market by the Therapeutic Goods Administration (TGA) of Australia for the prevention of cervical cancer and precancerous lesions caused by human papillomavirus types 16 and 18 for use in females ages 10 to 45 years.[9] This is the first time that a cervical cancer vaccine has been approved with an explicit indication anywhere in the world for women over the age of 26. Subsequent licenses have been granted in other international markets.

GSK submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its cervical cancer candidate vaccine in March 2007, following earlier regulatory filings with the European Medicines Agency (EMEA) and regulatory filings in Africa, Asiaand Latin America.

About cervical cancer

Cervical cancer is the second leading cause of cancer in women, and causes over 270,000 deaths worldwide per year.[10] 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.[11],[12] Approximately 100 types of human papillomavirus have been identified to date[13] and, of these, approximately 15 virus types are considered to cause cervical cancer.[14] Virus types 16 and 18 are responsible for approximately 67 per cent of cervical cancers in Asia.[15]

About GlaxoSmithKline and GlaxoSmithKline Biologicals

In the next five years, GSK expects to launch a number of significant new vaccines to protect against a range of serious diseases.

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.

References

[1]Japanese National Cancer Center: http://www.ncc.go.jp/en/ncch/annrep/2002/gynecology.html

[2]Japanese National Cancer Center: Center for Cancer Control and Information Services:http://ganjoho.ncc.go.jp/professional/statistics/statistics.html

[3]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 IIIrandomized, controlled trial in young women. The Lancet2007; 369: 2161-2170

[4]Koutsky L et al. Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions. New EnglandJournal of Medicine356;19:15-1927

[5]Approved European Cervarix Product Information September 2007

[6]Gall SA, et al. Substantial impact on precancerous lesions and HPV infections through 5.5 years in women vaccinated with the HPV-16/18 L1 VLP AS04 candidate vaccine. Presented at the American Association for Cancer Research (AACR) annual meeting, 14-16 April 2007 (abstract no. 4900)

[7]Rombo L, Dubin G. Long-term safety and immunogenicity of a cervical cancer candidate vaccine in 10-14-year-old adolescent girls. Presented at the European Society of Paediatric Infectious Diseases (ESPID) annual meeting on 2-5 May 2007

[8]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

[9]Approved Australian Cervarix Product Information May 2007

[10]Ferlay J, Bray P, Pizani P, Parkin DM. Cancer incidence, mortality and prevalence worldwide. Available at: GLOBOCAN 2002. Accessed September 20, 2005

[11]GravittPE, Jamshidi R. Diagnosis and management of oncogenic cervical human papillomavirus infection. Infect Dis Clin North Am, 2005; 19:439-458

[12]Castle PE, Schiffman M et al. A prospective study of age trends in cervical human papillomavirus acquisition and persistence in Guanacaste, Costa Rica. J of Infect Diseases 2005; 191; 1808-1816

[13]de Villiers E, Fauquet C, Broker T, Bernard H, zur Hausen H. Classification of papillomavirus. Virology 2004; 324: 17-27

[14]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. Int J Can 2004; 111: 278-285

[15]Clifford G et al. Chapter 3: HPV type-distribution in women with and without cervical neoplastic diseases. Vaccine 24S3(2006)S3/26-S3/34