Merck, QIAGEN to collaborate to increase access to HPV vaccination and HPV DNA testing in developing countries

Merck & Co., Inc. and QIAGEN N.V. today announced their intent to collaborate on a new program to increase access to HPV vaccination and HPV DNA testing in some of the most resource-poor areas of the world. This initiative is the first time a vaccine manufacturer and a molecular diagnostics company are collaborating to address the burden of cervical cancer with a comprehensive approach. Representing a combined value of approximately $600 million based on current U.S. prices, the commitments of Merck and QIAGEN were highlighted today among a select group of corporate initiatives announced at the annual meeting of the Clinton Global Initiative.

"My dream of helping to reduce the burden of cervical cancer for women is increasingly within reach. I commend Merck and QIAGEN for their contribution to advancing women's health," said Graça Machel, founder and president of the Foundation for Community Development (FDC), Mozambique, and a passionate advocate for women's health. "This program is a fine example of how vaccination and screening can be used together in a comprehensive fashion. I hope that this will pave the way for new partnerships, involving the public and private sectors, donor organizations and global health leaders to address cervical cancer in developing countries."

This collaboration will integrate two breakthrough and 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 (called 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, for free, up to five (5) million doses of GARDASIL and QIAGEN intends to add to its existing one million test donation program 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 programs, provide treatment as needed, and 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."

“With broadened access to both vaccines and testing through this initiative, we hope to ensure that girls and women - regardless of where they live – will benefit from these advances in healthcare," said Peer Schatz, CEO of QIAGEN. "Our complementary tools can demonstrate the unique impact that collaborations between pharmaceutical and diagnostic companies can have on global public health.”

Merck and QIAGEN plan to reach out to select GAVI-eligible countries to explore the feasibility of implementing cervical cancer reduction programs. These programs are expected to be national in scope - all girls within a defined age range in the selected countries would be offered vaccination, and the program 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 program details and implementation strategies have been finalized. While both companies are willing to work with countries on an individual basis, Merck and QIAGEN strongly believe that working together to develop country-wide programs that include cervical cancer vaccination and screening would 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. In the U.S., the vaccine is indicated for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 cause approximately 70 percent of cervical cancer cases.

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 U.S. and Europe where it is used as a screening test. In the U.S., it is approved to be used together with a Pap test in women 30 years and older. In Europe it is approved as an initial general population screening test either alone or together with a Pap test. It is also used as a follow-up to inconclusive Pap test results and as a post-cervical cancer treatment follow-up. 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 programs 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 about 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.