New Vaccine to help fight against Cervical Cancer

24 January 2008

New Vaccine to help in the fight against Cervical Cancer

Each year over 5000 NZ women will have an abnormal Pap smear that requires follow up

GlaxoSmithKline’s vaccine Cervarix® was approved today by Medsafe for women aged 10-45 years for the prevention of cervical cancer, precancerous lesions and cervical abnormalities caused by Human Papillomavirus (HPV) types 16 and 18. Types 16 and 18 are responsible for more than 70 percent of cervical cancers worldwide.1 Cervarix is also approved in over 40 countries around the world.

Cervical cancer and cervical abnormalities can have a large impact on New Zealand society.

Each year approximately 400,000 cervical smears are taken with over 5,000 women having abnormal results and having to face the anxiety and trauma of treatment and/or follow-up.2 "Cervical cancer continues to affect the health and lives of New Zealand women", said Professor Ron Jones, Chairman of the New Zealand Viral Sexually Transmitted Infection Foundation.

"Together with our national cervical screening programme, the availability of further HPV vaccines in New Zealand provides an opportunity to improve the health of women in the future."

To date, over 40,000 women have participated or are currently taking part in clinical trials to evaluate the efficacy and immunogenicity of Cervarix. Using an innovative adjuvant, AS04, Cervarix has been shown to provide strong and sustained immune responses and maintained 100% protection against precancerous lesions caused by HPV 16/18 for up to 5.5 years following vaccination.1,3 Furthermore Cervarix is the only HPV vaccine also indicated for women aged 27-45.1,4 Whilst the highest rates of HPV infection are found in younger women,5 all sexually active women remain at risk of cervical cancer throughout their life.6 “The registration of Cervarix is great news for women in New Zealand,” said GSK’s Director of Commercial Operations, Michael Bryant. “Coupled with the excellent clinical trial results published recently, this is further evidence of the potential for Cervarix to help reduce the burden of cervical cancer."

Clinical studies for Cervarix demonstrate it is generally well-tolerated.1 The most common reactions observed after vaccine administration were injection site reactions including pain, redness, swelling and general symptoms such as fatigue.1 Page 2 of 2 Cervarix is not intended for the treatment of HPV infections or cervical lesions present at the time of vaccination or to prevent the progression of established lesions. Cervarix may not prevent HPV infection and related clinical outcomes due to other cancer-causing HPV types.1 It is therefore important to note that regular Pap smears are still required for women who are vaccinated with Cervarix.

ENDS

About GlaxoSmithKline

GlaxoSmithKline is one of the world’s leading vaccine manufacturers. GSK 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.

GSK distributes more than 1.1 billion doses of vaccines annually 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. GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

About Cervarix®

Cervarix (Human Papillomavirus Vaccine (HPV) Types 16 and 18 - Recombinant, AS04 Adjuvanted) is an injection, 0.5mL per dose. Cervarix is registered in New Zealand as at 24 January 2008, and is not yet available for sale; therefore the funding status of this vaccine has not yet been determined. Cervarix is a Prescription Medicine for the prevention of cervical cancer by protecting against cervical HPV infections, Pap smear abnormalities and pre-cancerous lesions caused by HPV types 16 and 18 in females from 10 to 45 years of age. Use strictly as directed.

Do not have Cervarix injections if you are allergic to any component of the vaccine.

Tell your doctor if you have a fever, a low blood platelet count, or any blood clotting disorders. Cervarix is not intended to treat cervical HPV infections or lesions present at the time of vaccination or to prevent the progression of established lesions present at the time of vaccination.

Cervarix may not prevent HPV infection and related clinical outcomes due to other cancer-causing HPV types. Vaccination is not a substitute for regular Pap screening or for taking precautions against exposure to HPV and sexually transmitted diseases. There is little information to recommend the use of Cervarix during pregnancy; therefore vaccination should be postponed until after pregnancy.

Side Effects: Some common reactions observed after receiving the vaccine were pain, redness and swelling at the injection site, aching muscles or muscle tenderness, headache, fatigue, joint pain, itching, rash, nausea, vomiting, diarrhoea and fever. If symptoms continue or you have side effects, see your doctor, pharmacist or health professional. Additional consumer information about Cervarix is available from GSK as described above in this press release. When available, prices for Cervarix may vary across doctors’ surgeries; other normal doctor's office visit fees will apply. Ask your doctor if Cervarix is right for you. Cervarix is a trademark of the GlaxoSmithKline group of companies. Marketed by GlaxoSmithKline NZ Limited, Auckland. TAPS No DA711AH/08JA/004.

References

1. Cervarix® Data Sheet, GSK New Zealand
2. Quarterly Monitoring Report 26. National Cervical Screening Programme. January to March 2007
3. Gall SA et al. AACR 2007 Annual Meeting, Abstract 4900. April 14-18 2007, Los Angeles.
4. Gardasil® Data Sheet, CSL New Zealand
5. Dunne E, Unger E et al. JAMA 2007;813-819
6. Grainge MJ et al. Emerg Infec Dis 2005;11:1680-1685

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