GlaxoSmithKline’s (GSK) Press Release Issued:
Thursday 20th November 2008, London UK
GlaxoSmithKline’s (GSK) cervical cancer vaccine, Cervarix TM, was today confirmed by the Netherlands Vaccine Institute (NVI) as the cervical cancer vaccine for the Dutch National Immunisation Programme (NIP). GSK will supply Cervarixfor the programme, which aims to vaccinate all 12 year old girls. A catch-up programme for all girls aged 13 to 16 will also start within the first half of 2009, with the aim of reducing the risk of HPV infection and cervical cancer for a broader group of Dutch girls. The National programme for girls aged between 12 and 13 will commence in September 2009. It is estimated that more than 350,000 girls in total will be vaccinated with Cervarix in the first year.
“We are delighted with this decision and the fact that since Cervarix received European approval it has been selected as the cervical cancer vaccine for more than half of eligible tenders across Europe,” said Eddie Gray, President of Pharmaceuticals Europe for GSK. “We look forward to working with the Netherlands Vaccine Institute to support the successful implementation of the Public Health vaccination programme so that girls in the Netherlands will benefit from the effective and sustained protection against cervical cancer which Cervarix offers.”
Cervarix has been designed specifically to protect against cervical cancer and has demonstrated high protection against HPV 16 and 18, which are responsible for approximately 70% of cervical cancers1 worldwide. With clinical data from over 6 years of follow-up, Cervarix has the longest duration of protection reported for any HPV vaccine to date.
In the Netherlands, the cervical cancer NIP has been added to the existing National Screening Programme that recommends women of 30 years and over have a PAP-smear test every five years in order to combat cervical cancer. It is estimated that nationally, up to 700 women are diagnosed with cervical cancer and more than 200 die from the disease each year, making it the second biggest killer of women after breast cancer.2 Cervical cancer is the second leading cause of cancer death among women globally, killing one woman every two minutes.3,4 As well as the deaths associated with the disease, cervical cancer and pre-cancerous lesions are also a significant cause of emotional and physical distress in women.5Alongside screening and a healthy lifestyle, vaccination is expected to significantly reduce the lifetime risk of cervical cancer.6
Notes to Editors
About the Dutch National Immunisation Programme
From 2009, cervical cancer vaccination will be routinely recommended for all girls between 12 and 13 years of age (first year of secondary education). There will also be a catch-up programme in the first half of the year where girls aged 13 to 16 years will be offered the vaccine. Cervarix TM was selected as the cervical cancer vaccine for the Dutch National Immunisation Programme.
About cervical cancer and its progression
Approximately 100 types of HPV have been identified to date7 and, of these, approximately 15 virus types are known to cause cervical cancer.1 Virus types 16 and 18 are responsible for approximately 70% of cervical cancers.1 Persistent infection with cancer-causing virus types can lead to the formation of abnormal cells in the cervix, which, over time, may become precancerous or cancerous.8 Throughout their sexually active lifetime, women may be exposed to cancer-causing virus types. The majority of women will clear an infection spontaneously. However, if the infection persists it can lead to precancerous lesions or cervical cancer.9
Experts believe that neutralising antibodies – so-called because they have the ability to neutralise cancer-causing virus types and prevent them from infecting cells in the cervix – are essential for cervical cancer protection, post-vaccination.10-12 The World Health Organization (WHO) states that neutralising antibodies are the likely mediatorof vaccine-induced protection from infection.11,12
Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.4
About the GSK Cervical Cancer Vaccine
CervarixTM has been specifically designed by GSK to provide women with protection against cervical cancer, targeting the two human HPV types, 16 and 18, that are responsible for over 70% of cervical cancer.1
To-date, GSK’s cervical cancer vaccine has been approved in more than 80 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 30 additional countries including Japan. In September 2007, GSK submitted CervarixTM to the WHO for prequalification, towards distribution across the developing world via the United Nations and the GAVI Alliance. GSK also submitted a Biologics Licence Application (BLA) to the U.S. Food and Drug Administration (FDA) for CervarixTM in March 2007.
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 further information please visit www.gsk.com
GSK Biologicals (GSK Bio) – is a global vaccine company which has shown itself to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Bio has 14 manufacturing sites strategically positioned around the globe. GSK Bio employs over 9,000 people worldwide including more than 1,600 passionate scientists engaged in research aimed at developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2007, GSK Bio distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, more than one in every ten doses delivered were combination vaccines intended to prevent up to six diseases in one vaccine.
CervarixTM is a trademark of the GlaxoSmithKline group of companies.