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Marketing Application for Cervarix, GSK’s Candidate Vaccine for Cervical Cancer, Submitted in the European Union


GlaxoSmithKline (GSK) has submitted for review a marketing application for Cervarix™- the company’s candidate vaccinefor cervical cancer – to the European Agency for the Evaluation of Medicinal Products (EMEA).

Cervarix™has been developed to prevent infection from the two most prevalent cancer-causing types of the human papillomavirus (HPV), specifically HPV 16 and 18, which together are responsible for over seventy percent (70%) of cervical cancer globally.[1]

In clinical trials, Cervarix™was the first to demonstrate 100% protection from persistent infection against both HPV 16 and HPV 18 and protection from precancerous lesions.[2] In the same trials, preliminary evidence of broader protection against other cancer-causing strains of HPV, in addition to HPV 16 and 18, was shown.[3] Cervarix™ is formulated with the proprietary innovative adjuvant AS04, selected to ensure that Cervarix™ confers strong and sustained antibody levels in women.[4]

Dr Anne Szarewski, from Cancer Research UKcommented, “In my opinion, HPV vaccination will significantly reduce not only the health burden caused by cervical cancer, but also the anxiety suffered by women around Pap smears and particularly around abnormal results. It has the potential to revolutionize women’s health. A cervical cancer vaccine is a major innovation and an important development for women everywhere.”

Andrew Witty, President of GSK Pharmaceuticals Europe noted, “Today’s submission of the Cervarix™ file is an important milestone for women everywhere. We developed this vaccine with the ambition to provide all women with the best possible protection against cervical cancer throughout their life and are delighted with the progress we are making towards bringing the vaccine to market. Our efforts demonstrate GSK’s commitment to develop innovative products that have a major impact in preventing life-threatening disease for women.”

GSK’s international regulatory filings for Cervarix™ will follow in Australia, parts of Asiaand Latin Americafrom March 2006, with submission to the US Food and Drug Administration (FDA) by the end of 2006.

Notes to Editors:

About Cervarix™

Cervarix™was developed to prevent infection from the two most prevalent cancer-causing types of the human papillomavirus (HPV), specifically HPV 16 and 18. In clinical trials, Cervarix demonstrated excellent protection from persistent infection against both HPV 16 and HPV 18 and associated precancerous lesions.2 Cervarix™is formulated with the innovative proprietary adjuvant AS04 selected to ensure that Cervarix confers high and sustained antibody protection levels.

About HPV and cervical cancer

HPV infection is very common; every sexually active woman is at risk of contracting a type of HPV, which may cause cervical cancer. While there are many different types of HPV that may cause cancer, HPV 16 and 18 account for more than 70 per cent of all cervical cancers globally.1

Cervical cancer is a major global health problem, with nearly 500,000 new cases occurring each year worldwide. It is the second most common cancer - and the third leading cause of cancer deaths - in women worldwide. Each year an estimated 270,000 women die from the disease, and it is the leading cancer killer of women in the developing world.[5]

About GlaxoSmithKline and GlaxoSmithKline Biologicals

In the next five years, GSK expects to launch more major new vaccines: a vaccine against rotavirus, 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

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 2005, GSK Bio distributed more than 1.2 billion doses of vaccines to 165 countries in both the developed and the developing world, an average of more than 3 million doses per day.


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