Merck to Donate Three Million Doses of Gardasil®, its Cervical Cancer Vaccine, to Support Vaccination Programmes in Lowest Income Nations

AUCKLAND, October 17 – Merck & Co., Inc. has committed to donate at least three million doses of GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine], the cervical cancer vaccine, for use in demonstration projects in low income nations throughout the world.

The programme, part of Merck's comprehensive approach to bringing newer vaccines to the developing world, is Merck’s commitment to the Clinton Global Initiative.

"By donating three million doses of GARDASIL over the next five years, we are committing to the vaccination of one million females against cervical cancer, a disease that takes the lives of nearly 250,000 women each year," said Margaret G. McGlynn, President, Merck Vaccines and Infectious Disease.

"Our company is fully committed to making GARDASIL available to those who need it and we will continue to work with our partners in the international community to develop sustainable solutions to bring GARDASIL and other vaccines to the developing world."

GARDASIL is proven to help protect against diseases that are caused by four types of the human papillomavirus: HPV types 16 and 18, which cause 70 percent of cervical cancer cases, and HPV types 6 and 11, which cause 90 percent of genital wart cases.

Merck is pursuing a systematic approach to the global introduction of two of its vaccines, ROTATEQ® (rotavirus vaccine, live, oral pentavalent) and GARDASIL, and is committed to making both vaccines available to developing world nations at dramatically lower prices at which Merck will not profit.

Merck has made an important stride toward making ROTATEQ available in the developing world through its partnership with the Nicaraguan Ministry of Health which was announced at the Clinton Global Initiative in September 2006.

This joint partnership marks the first time that a vaccine was introduced into a low income country in the same year it was approved by the U.S. Food and Drug Administration (FDA). Merck also continues to support GAVI initiatives designed to increase access to all vaccines, including rotavirus vaccines, in low income countries.

There are enormous challenges to achieving high immunisation rates in developing world nations, and historically, there has been a significant delay between the introduction of new vaccines in developed countries and when they are widely available in developing countries.

"Much progress is being made to shorten the delay, but HPV vaccination in the developing world has not yet been prioritised by the international community," said Ciro de Quadros, President Emeritus and Director for International Programmes, Sabin Vaccine Institute.

"The GARDASIL access programme will empower resource-poor nations and their partners to develop programmes to bring this critical vaccine to people in need."

To implement this programme, Merck will establish a partnership with a non-governmental organisation to establish formal criteria for the programme and to review proposals from developing world nations working independently and/or with non-governmental organisations, governments, or international organisations. Merck will provide free doses of GARDASIL for use in these programmes.

"This programme is modelled on Merck's pioneering public-private partnerships that have brought Mectizan, our HIV medicines and ROTATEQ to the developing world," said Mark Feinberg, Vice President, Policy, Public Health and Medical Affairs, Merck Vaccines and Infectious Disease.

"In just the first year of Merck's collaboration with the government of Nicaragua, we demonstrated that a developing nation can successfully introduce a new vaccine as quickly as developed nations. For GARDASIL, we know that this programme is an interim step, and an important one that will create models of successful HPV vaccination in resource-poor countries."

GARDASIL is indicated to help prevent cervical cancer, precancerous and low-grade cervical lesions, vulvar and vaginal precancers and genital warts caused by human papillomavirus (HPV) types 6, 11, 16 and 18.

Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly 500,000 diagnoses each year.

Merck launched GARDASIL, the world's first cervical cancer vaccine, in the U.S. and other developed world nations in 2006. Since that time, GARDASIL has been approved in 85 nations, including 12 of the lowest income countries. Worldwide, Merck has distributed more than 10 million doses of GARDASIL as of June 30, 2007.

GARDASIL and ROTATEQ in New Zealand
GARDASIL and ROTATEQ are currently not funded in New Zealand, despite positive recommendations from the Ministry of Health's (MOH) Immunisation Technical Working Group (ITWG).

In 2006, the ITWG recommended that four vaccines be added to the New Zealand schedule (pneumococcal conjugate, HPV, rotavirus, and combination measles, mumps, rubella and varicella) however only one vaccine (pneumococcal conjugate) has received funding. In contrast, all four vaccines are funded in Australia.

GARDASIL is available in New Zealand at an average cost to patients of $165 per dose including the doctor's consultation fee.

In New Zealand GARDASIL is marketed by CSL Biotherapies (NZ) Ltd. In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.

Although ROTATEQ is a registered medicine in New Zealand it is not currently marketed here because it is not funded.

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