GARDASIL is administered in three separate intramuscular injections in the upper arm or thigh.

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Merck and QIAGEN collaborate to accelerate access to cervical cancer vaccination and screening in developing countries

Major new collaboration announced at Clinton Global Initiative Annual Meeting.

Merck & Co., Inc. and QIAGEN N.V. recently announced their intent to collaborate on a new programme to increase access to HPV vaccination and HPV DNA testing in some of the most resource-poor areas of the world.

This collaboration will integrate two complementary advances in healthcare: Merck's cervical cancer vaccine, GARDASIL® (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine Recombinant), and QIAGEN's HPV tests, the digene HC2 HPV DNA Test (known as the digene HPV Test) and a new HPV DNA test that is currently in development for use specifically in the developing world.

Merck intends to provide up to five million free doses of GARDASIL, and QIAGEN intends to add to its existing one million test donation programme by providing HPV DNA tests to screen an additional 500,000 women. Merck and QIAGEN plan to seek other public and private partners to design and implement national public sector cervical cancer programmes, to provide treatment as needed, and to support improvements in laboratory and vaccine delivery infrastructure, training of healthcare workers, education and advocacy. The two companies also plan to work with cervical cancer experts to support the development and implementation of sustainable best practice models for cervical cancer reduction in low-income, high disease burden countries.

‘Nearly every minute of every day a woman is diagnosed with cervical cancer, and many of these women live in developing countries where the burden of the disease is disproportionately high and healthcare infrastructure is limited,’ said Margaret G. McGlynn, president, Merck Vaccines and Infectious Diseases. ‘We see this collaboration between the two companies as innovative and fundamental to reaching our shared goal of reducing the global burden of cervical cancer.’

Merck and QIAGEN plan to select Global Alliance for Vaccines and Immunisation (GAVI)-eligible countries to explore the feasibility of implementing cervical cancer reduction programes. These programmes are expected to be national in scope – all girls within a defined age range in the selected countries would be offered vaccination, and the programme would work towards implementation of screening (and treatment as needed) for all women of a defined age group. The participating countries will be announced once programme details and implementation strategies have been finalized. Although both companies are willing to work with countries on an individual basis, Merck and QIAGEN strongly believe that working together to develop country-wide programmes that include cervical cancer vaccination and screening will bring unique benefits to global public health.

GARDASIL has received WHO prequalification and is approved for use in 112 countries, 23 of which are GAVI-eligible. GARDASIL has not been demonstrated to protect against diseases caused by HPV types not contained in the vaccine. Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV types 16 and 18.

HPV testing identifies women with high-risk HPV infections that can cause cervical cancer, enabling diagnosis and treatment to be put in place before cervical cancer develops. The digene HPV Test is approved in the USA and Europe, where it is used as a screening test. To ensure that HPV testing can reach women in all regions of the world, QIAGEN is developing a new HPV DNA test for public health programmes in low-resource countries. The cervical cancer collaboration with Merck will include the digene HPV Test, as well as the new HPV DNA test in development, when commercially available.

Cervical cancer affects approximately 500,000 women worldwide, and approximately 85 percent of these women live in the developing world. By affecting women in their most productive years, cervical cancer strikes at the heart of families and deprives developing world economies of the many important contributions women make.

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