The most significant outcome of Merck research efforts related to neglected tropical diseases is MECTIZAN^® (ivermectin), for the treatment of the parasitic infection onchocerciasis (river blindness). Following more than a dozen years of research and development, MECTIZAN was approved in 1987 to relieve the agonizing itching that accompanies the disease, and to halt progression toward blindness — two characteristics of the diseases that dramatically affect the quality and duration of life. With only one annual dose, MECTIZAN is well suited for distribution in remote areas by community health workers. It is the only well-tolerated drug known to halt the development of river blindness. Merck also donates MECTIZAN for the prevention of lymphatic filariasis (LF), commonly referred to as elephantiasis, in African countries where the disease co-exists with river blindness through the Global Alliance to Eliminate Lymphatic Filariasis. For more information, please click here.

Additional research efforts include:

Tuberculosis

Malaria

• In November 2006, a team of Merck scientists collaborated and co-authored a paper with the U.S. National Institutes of Health (NIH) describing results of a research collaboration to develop a malaria vaccine.¹
• In March 2009 Merck and Medicines for Malaria Venture (MMV), a not-for-profit virtual research and development organization dedicated to reducing the burden of malaria, announced a licensing agreement for an investigational drug candidate for the treatment of malaria in the developing world. Merck, whose researchers discovered the candidate, has granted MMV an exclusive, royalty-free license to pursue development of the investigational candidate for the treatment of malaria in malaria-endemic countries. Merck retains the option to become MMV's development partner upon completion of the first Phase II clinical trial of the candidate. Also within the agreement, Merck has committed not to profit from its sale in malaria-endemic countries.

Tropical Diseases

• In January 2008, Merck, along with several other pharmaceutical companies, agreed to provide financial support for the WHO/TDR Partnership Network (Special Program for Research and Training in Tropical Diseases (TDR)), an independent global program of scientific collaboration.  Potential collaboration involves industry grants to scale up TDR's network infrastructure for (1) maintaining capacities for drug testing in cell and animal models; (2) maintaining its database of drug targets and information on known "drug-ability" of the targets; and (3) evaluation and feedback to collaborating institutions.
• In 2009, Merck and DNDi (Drugs for Neglected Diseases Initiative) entered into a collaborative agreement to support discovery and development of improved treatments for a wide range of neglected tropical diseases (NTDs).  Merck will contribute small molecule assets and related intellectual property via a non-exclusive, royalty-free license to DNDi to conduct early development programs for drug candidates for treatment of NTDs, with the primary goal of manufacture and distribution of drugs at low cost to the public sector in resource-poor countries.  Merck and DNDi will share joint intellectual property on drug candidates generated through early development, and Merck will retain the option to undertake late clinical development and registration of drug candidates.

Other Major Research Initiatives that Address Diseases with a High Prevalence in the Developing World

HIV and AIDS

Merck has had an intensive broad-based HIV and AIDS clinical research program since 1985 that has sought to address both treatment and prevention. Merck scientists established the role of protease in the HIV lifecycle in 1988 and were the first to publish the crystal structure of HIV protease one year later. They also were among the first to discover and develop medicines for the treatment of HIV and AIDS. Merck's work in collaboration with others in the early phase of HIV research played an important role in defining the principles for combination ARV treatment to suppress the virus to undetectable levels; achieving this goal continues to be the standard of care for treatment today.

Merck also has conducted research to develop pediatric formulations for its antiretrovirals (ARV) and continues to work with the U.S. President's Emergency Plan for AIDS Relief Partnership for Pediatric AIDS Treatment to identify scientific and technical solutions to improve access to ARV treatment for children living with HIV and AIDS in resource-limited settings.

Unfortunately, in September 2007, Merck's decade-long effort to develop an HIV vaccine were disappointed when the Company halted a phase II clinical trial of its investigational HIV vaccine because it was not effective. Hundreds of Merck employees have been involved in Merck's HIV vaccine development program during the past 20 years and have made extraordinary efforts.  Sadly, the development of a successful HIV vaccine remains one of the most challenging tasks facing modern medicine.  Merck remains deeply committed to analyzing the data and sharing it as broadly and as quickly as possible to add to the knowledge base for the entire field of HIV vaccine research.

In addition to our own research efforts, we have entered into partnerships with other researchers and scientific organizations to help accelerate the search for treatments and possible cures. Most recently in March 2008, reflecting the Company's ongoing commitment to finding ways to prevent and treat HIV and AIDS, Merck granted the International Partnership for Microbicides (IPM) a non-royalty-bearing, non-exclusive license to develop, manufacture and distribute a novel antiretroviral compound (L'644) for use as a vaginal microbicide in developing countries to help protect women from HIV.  The compound is the fourth we have granted to IPM since 2005.

Given the resistant nature of HIV, Merck remains focused on developing treatments and to working with external partners to help those who are living with this disease.

For more information on Merck's HIV and AIDS research and access programs, click here.

Rotavirus

In 2006, Merck introduced ROTATEQ, a vaccine against rotavirus, which causes hundreds of thousand of deaths in children in the developing world each year. Merck is working with the PATH Rotavirus Vaccine Program to conduct efficacy and safety studies in Asia and Africa (in sites in Bangladesh, Vietnam, Ghana, Kenya and Mali) to better understand the efficacy and safety of the vaccine in developing world environments, where factors including poor nutrition and the presence of intestinal bacteria and viruses might play a role in recipient response to the vaccine. In addition, as part of our partnership with the Government of Nicaragua, Merck is assessing the public health impact of introducing ROTATEQ into a GAVI-eligible country to help understand and disseminate the results that can be achieved with this product even in severely resource-limited environments.

Human Papillomavirus

In 2006, Merck introduced GARDASIL^® [human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant], a vaccine to prevent cervical cancers, precancerous and dysplastic lesions, and genital warts caused by the Human Papillomavirus. Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year. Many of these deaths are in the developing world where access to preventive screening is often rare and a vaccine could make a measurable impact on women’s health. Merck is working with PATH to conduct demonstration studies of GARDASIL in the developing world, by providing vaccine and technical support at no cost.  GARDASIL PATH studies in Peru, Vietnam and India are designed to inform how cervical cancer vaccines can most feasibly be used in resource-limited settings of diverse cultural backgrounds.  Together with the Indian Council of Medical Research, Merck is also studying GARDASIL in underserved populations in India.

Public Policy

Medicines and vaccines have helped improve the public health and economic wellbeing of societies and individuals in many countries worldwide, but some stakeholders are concerned that research efforts may be ignoring the diseases of the very poorest people because of lack of economic incentives. In addition, there is a perception by some that patents make medicines unaffordable for many people. As a result, there have been calls for the intellectual property protection system to be overhauled.

Studies show, however, that productive research is taking place on most of the so-called neglected diseases, and that patents are not the barrier to access that some people believe. Ninety-five percent of medicines and vaccines described as essential by the World Health Organization are not patented in developing countries yet very few people in those countries have access to them at all. We believe strongly that weakening the intellectual property system would not enhance access but would reduce the incentives for further innovation and that this would be detrimental to society as a whole.

Research is not based just on economic incentives such as intellectual property protection and markets; it also relies heavily on the existence of functioning health care systems and infrastructure, on systems for providing heath care, and on an effective regulatory framework. Inadequacies in any of these areas lessen the opportunities for research, and also place obstacles in the way of realizing access to medicines and vaccines. Our public policy and stakeholder engagement activities on this issue aim to inform related debates as well as discussions about unintended consequences of changing the current system.

Our public policy and advocacy activities strongly promote the importance of the intellectual property rights system to foster biomedical innovation. For more information, please click here.

With regard to informing the debate on research in neglected tropical diseases and other diseases prevalent in the developing world, Merck has participated in numerous forums, including:

• The 2008 Infectious Diseases Summit in Washington, D.C., which focused on leveraging private-sector skills for health system development and capacity building. The Summit focused on the practical and operational aspects of capacity building for the prevention and control of infectious diseases including activities that strengthen the knowledge, abilities, skills and behavior of individuals and improve institutional processes and management structures.
• The 2008 Partnering for Global Health forum, organized by Bio Ventures for Global Health and the Biotechnology Industry Organization (BIO), and sponsored by the Bill and Melinda Gates Foundation.  Other organizations represented included the National Institutes of Health, the Global Health Council and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Merck reviewed our commitment to and actions in the developing world, and discussed partnerships, policies and incentives that are required to achieve product development and delivery to where they are needed, including U.S. incentives for neglected tropical disease drug development.