We continue to seek ways in which we can contribute expertise and resources to these disease areas.
We apply our research and development expertise and technology to identify potential products that would address unmet needs in resource-poor settings, particularly treatments for infectious diseases, such as HIV and hepatitis C virus (HCV), and for vaccine-preventable diseases, such as pneumococcual disease. We are also involved in a number of product-development partnerships and research collaborations to further develop treatments for both infectious and chronic diseases.
Merck recognizes that new methods and a broader scope of partnering—with both public and private entities—are critical to continuing innovation. This is true for all diseases, and especially true for neglected diseases, for which the relevant expertise spans academia, local public health authorities, industry and international agencies. We plan to continue to expand our interaction with these groups in order to understand key research priorities and opportunities, and to provide relevant expertise and resources.
We also recognize that our access strategy and research capabilities play an important role in recruiting outstanding scientists as well as potential external research alliance partners, who want to know that the fruits of their discoveries will be available to patients worldwide.
About one in four deaths worldwide is caused by infectious and/or parasitic diseases—totalling nearly 15 million people each year. Merck aims to lead in this field and develop new anti-infectives for the treatment of HIV and HCV as well as other infectious diseases. Merck also has a broad range of resources to address neglected tropical diseases (NTDs). For decades, we have been directly engaged with NTDs through program implementation, R&D, and policy and advocacy efforts. We aim to build on our leadership position in the coming years, through a variety of in-house activities and strategic external partnerships.
We are also committed to developing medications that provide benefits to patients in the greatest need, and thus truly change current treatment paradigms.
Merck has sought to make a difference in the fight against HIV, including in the developing world. Since 1985, we've been engaged in R&D efforts for both HIV prevention and treatment. After decades of working to increase access to HIV treatment in the developing world, it is clear that access to care is about more than the price of medicines and that collaboration has been essential to the progress made.
In December 2011, the Merck Global Health Innovation (GHI) fund invested $5 million in Daktari Diagnostics Inc., a developer of point-of-care diagnostic systems for global health applications. Merck GHI led the $10 million round, joined by the company's current investor group. Funds will be used to complete development and bring to market the company's initial products, intended for use in monitoring HIV patients worldwide, and to expand the point-of-care product-development pipeline. Dakarti's product-development pipeline is focused on diagnostic tests for conditions prevalent in low- and middle-income countries, including HIV, tuberculosis, hepatitis, typhoid and conditions related to maternal health. Products are designed for use by minimally trained health workers who support care at district hospitals, health centers and other local health facilities in the developing world.
Merck is committed to working with governments, donors, innovator and generic manufacturers, multilateral organizations and civil society to address the full range of factors affecting access to care.
Read more about our global HIV-treatment access strategy.
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. The WHO reports that every year, 3 to 4 million people are infected with the hepatitis C virus (HCV). About 150 million people are chronically infected and at risk of developing liver cirrhosis and/or liver cancer. More than 350,000 people die from hepatitis C–related liver diseases every year. To address the medical need, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. Extensive research efforts are underway to develop oral therapies that bring innovation to viral hepatitis treatment.
In May 2011, Merck announced that it entered into agreements with Roche, through its respective subsidiaries, to improve treatment, diagnosis and awareness of chronic hepatitis C infection in developed and emerging markets. Researchers affiliated with both companies will collaborate to examine novel combinations of marketed and investigational medicines from both organizations to expedite the availability of potential new treatment regimens for patients with HCV.
Merck MECTIZAN® Donation Program: One of the most significant outcomes of Merck research in neglected tropical diseases has been MECTIZAN (ivermectin), for treatment of the parasitic infection onchocerciasis (river blindness). After 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 the progression toward blindness—both of which 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, and 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 coexists with river blindness.
In alignment with our commitment to discovering a treatment for Chagas disease, in June 2010 we announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate the oral antifungal agent posaconazole (marketed as NOXAFIl® oral suspension in the U.S. and the EU, and in several other countries), for the treatment of chronic Chagas disease. In planning the study, Merck consulted with international agencies and research organizations to identify current medical needs and reach consensus on a study design for posaconazole in asymptomatic chronic Chagas disease. Results from this study are expected in 2012.
In January 2012, Merck announced that it had joined 12 other global pharmaceutical companies, as well as governments and other leading organizations, including the World Health Organization (WHO), the Bill & Melinda Gates Foundation and the UK Department for International Development (DFID) in signing the London Declaration, a collaborative effort to accelerate progress toward eliminating or controlling 10 neglected tropical diseases (NTDs) by the end of the decade. To guide the effort against NTDs, the WHO unveiled a new publication and strategy, “Accelerating work to overcome the global impact of neglected tropical diseases—A roadmap for implementation”.
In June 2009, Merck and the not-for-profit organization Drugs for Neglected Diseases Initiative (DNDi) entered into a collaborative agreement to support the discovery and development of improved treatments for a range of NTDs. The partnership focuses on numerous NTDs, including visceral leishmaniasis and Chagas disease, both of which infect millions of people. Through a nonexclusive, royalty-free license to DNDi, Merck is contributing small-molecule assets and related intellectual property for DNDi to conduct early development programs for drug candidates for treatment of NTDs, with the primary goal of manufacturing and distributing drugs at low cost to the public sector in resource-poor countries. Merck and DNDi will share joint intellectual property rights on drug candidates generated through early development, and Merck will retain the option to undertake late clinical development and registration of these drug candidates.
In 2011, Merck joined a a newly established R&D consortium called WIPO Re:Search, with a mission to accelerate the discovery and development of medicines, vaccines and diagnostics for NTDs, tuberculosis and malaria by making intellectual property (IP) and know-how available to the global health research community. Merck is contributing financial support and IP in partnership with the World Intellectual Property Organization (WIPO), BIO Venture for Global Health (BVGH) and other partners.
In December 2010, Merck announced a partnership with the NYU Langone Medical Center and the PATH Malaria Vaccine Initiative (MVI) that will focus on creating a vaccine that prevents an essential early stage of malaria infection: the invasion of the human liver by the malaria parasite. The partnership leverages Merck's own expertise along with the NYU Langone Medical Center's extensive research into malaria and MVI's critical funding resources.
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 an exclusive, royalty-free license to pursue development of a licensing agreement for an investigational drug candidate (MK-4815) for the treatment of malaria in the developing world. In June 2012, MMV terminated its license, and all rights to MK-4815 were returned to Merck. We are in the process of identifying a new outlicensing partner.
MSD Spain is a founding supporter of Fundación Medina, a nonprofit public-private partnership between MSD, the Junta de Andalucia and the University of Granada that focuses on the discovery of new compounds and innovative therapies for infectious diseases, including malaria.
The Merck Company Foundation supported the University of Medicine & Dentistry of New Jersey with a grant of $250,000 over five years (2006–2011) to support the Public Health Research Institute's research of drug targets for tuberculosis.
Vaccines are considered one of the most significant public health achievements of the 20th century. Merck has been at the forefront of vaccine advances for decades and remains committed to discovering and developing vaccines to help save lives through its products, partnerships and programs.
Merck looks to establish new business models and partnerships for research and development. The MSD-Wellcome Trust Hilleman Laboratories, a joint venture between Merck and the Wellcome Trust, marks the first time a pharmaceutical company and a research charity have partnered to form a separate entity with equally shared funding and decision-making rights. At the heart of this concept is the creation of a sustainable R&D organization that operates like a business, but with a not-for-profit operating model, to address the vaccine needs of low-income countries. As well as developing new vaccines in areas of unmet need, the Hilleman Laboratories, based in India, will also work to optimize existing vaccines, an important and powerful way of increasing the impact of vaccination in resource-limited settings.
The partners have strengths that are complementary in many ways. The Wellcome Trust brings exceptional public health expertise, in-depth policy understanding and experience in biomedical research to the partnership. Merck brings expertise in vaccine development and experience in working with a diverse range of stakeholders including international organizations, governments, nongovernmental organizations and philanthropic organizations.
The Hilleman Laboratories is based in India to facilitate engagement and partnership with a broad range of experts in vaccine research, policy and manufacturing to develop and mature its R&D pipeline. Its first R&D laboratory is now operational at the Jamia Hamdard University, in New Delhi.
Specific projects will be selected through consultation with the international community and careful technical assessment. In 2011, the organization announced its first project, a feasibility study on how new technologies might be used to develop a rotavirus vaccine designed specifically to meet the needs of developing countries. The Hilleman Laboratories will partner with external collaborators with expertise in formulation and relevant technologies. To learn more, click here.
In August 2011, we announced an agreement to work with the Serum Institute of India Limited, an Indian company, to develop and commercialize a pneumococcal conjugate vaccine (PCV) for use in emerging and developing-world countries. It is estimated that one out of every two children immunized worldwide is by a vaccine manufactured by Serum Institute. In addition, Merck has developed many of the world's vaccines for children, adolescents and adults.
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 (HPV). 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 partnered with the international nonprofit organization PATH to provide GARDASIL for the conduct of HPV-vaccine demonstration projects in Peru, Vietnam and India. GARDASIL was provided to vaccinate approximately 30,000 appropriate girls participating in HPV Vaccines: Evidence for Impact demonstration projects. The overall initiative was designed to (1) strengthen the capacity of developing countries to prevent cervical cancer by generating and providing necessary evidence for public sector introductions of HPV vaccines; (2) inform global advocacy efforts; and (3) provide analyses to help accelerate access to HPV vaccines. The projects’ outcomes suggest that high coverage with HPV vaccine can be achieved through various delivery strategies in the countries studied.1
In addition, in 2007, Merck announced the GARDASIL Access Program (GAP), a charitable donation program through which Merck has committed to donate at least 3 million doses of GARDASIL to eligible applicants in lowest-income countries around the world. The program enables participating countries to gain operational experience in designing and implementing HPV vaccination projects. Learn more.
In 2006, Merck introduced ROTATEQ® (rotavirus vaccine, live, oral pentavalent), a vaccine against rotavirus, which causes hundreds of thousands of deaths in children in the developing world each year. In 2009, Merck completed clinical trials of the PATH Rotavirus Vaccine Program, which studied the safety and efficacy of ROTATEQ in Bangladesh, Vietnam, Ghana, Kenya and Mali. Trials at all sites in Africa and Asia involved more than 7,500 infants and were published in the August 2010 issue of The Lancet. The results of these studies supported expanded WHO recommendations to promote global use of ROTATEQ.
In addition, as part of our partnership with the Government of Nicaragua, Merck assessed the public health impact of introducing ROTATEQ into a GAVI-eligible country. The significant public health impact of the introduction and widespread use of ROTATEQ in this program was demonstrated through a case control study of the effectiveness of vaccination. Over a two-year period, three doses of Merck's rotavirus vaccine reduced the risk of hospitalization or emergency-department visits for severe rotavirus disease by 76 percent for health centers and hospital visits combined. The vaccine also demonstrated high vaccine effectiveness (87 percent) against severe disease among children younger than 12 months of age at the time of onset of acute disease.
1 LaMontagne et al, Bull World Health Org 2011.
According to the WHO, chronic diseases, such as heart disease and diabetes, are by far the leading cause of mortality in the world, resulting in 63 percent of all deaths. Out of the 36 million people who died from a chronic disease in 2008, 9 million were under 60 years of age, and 90 percent of these premature deaths occurred in low- and middle-income countries.
In July 2011, Merck and China's Simcere Pharmaceutical Group announced the signing of a framework agreement to establish a joint venture focused on serving China's rapidly expanding healthcare needs by providing significantly improved access to quality medicines in major therapeutic areas. This innovative partnership will combine the extensive resources and expertise of a global healthcare company with a leading Chinese pharmaceutical company in support of Merck and Simcere's goal of building a strategic partnership with development, registration, manufacturing and sales capabilities. Its initial focus will be branded pharmaceutical products for cardiovascular and metabolic diseases.