Taking Aim at Neglected Diseases

Courtesy of John D. McKinney and Clifton Barry In Singapore, we have found the best of both worlds. Two years ago, Novartis established a public-private partnership called the Novartis Institute for Tropical Diseases (NITD) in this Southeast Asian island-state. The NITD, a wholly owned Novartis affiliate supported by Singapore's Economic Development Board, is now focusing on discovering novel ways to prevent and treat tuberculosis and dengue fever–two neglected diseases prevalent in the developing world. Our long-term aim is to help reduce the risk of these and other tropical diseases, and ultimately, to improve the prosperity of developing countries. Singapore was not a random choice to host the institute. We chose Singapore for this first-of-its-kind research center because of its proximity to patients and academia, its attractiveness to scientists and, of course, because the government welcomed and supported the institute. The NITD is an important part of Singapore's campaign to foster development of a local biomedical industry and reduce the nation's dependence on the electronics industry. The city-state has solid intellectual property protection, which also made it an attractive site for the institute. The NITD differs from the typical Novartis operation–and that of the pharmaceutical industry in general–in several unusual, fundamental, and very positive ways. First, unlike most of our operations, the NITD is nonprofit; that is to say, the Novartis Group intends to make treatments produced at the NITD readily available and without profit to poor patients in tropical countries. The NITD is thus a core component of the Novartis Corporate Citizenship program. Second, the institute focuses on diseases endemic in the developing world and we're training scientists from both the developed and developing worlds in drug-discovery science for these tropical diseases. Typically, pharmaceutical companies concentrate on finding treatments for diseases more commonly suffered by those in the developed world, who can afford to pay for such therapies. Third, the NITD is a public-private partnership that is working with nonprofit groups such as Doctors Without Borders to accomplish its goals. This is relatively rare in the pharmaceutical industry because nonprofit groups, particularly those involved with the diseases that plague the poorest countries, often look on the motives of profit-making pharma companies with some suspicion–sometimes justified, sometimes not. CORPORATE CITIZENSHIP Many infectious diseases occur in the developing world and affect millions of patients who have not benefited from the biomedical science revolution. Pharma companies have de-emphasized these diseases because of the lack of viable financial return, which as commercial enterprises, the companies need. Novartis and its stakeholders believe, however, that these diseases should not be neglected any longer, even if the pharmaceuticals used to treat them will not make a profit in the foreseeable future. We believe it's simply a matter of humanity and corporate social responsibility. Paul Herrling The NITD is in its second year, and we know now that the institute is well-positioned to truly make a difference in meeting patients' needs. Encouragingly, leads contributed by other Novartis research centers have given the NITD a head start. On its own, the NITD is a relatively small institution with a scientific staff of about 70 people. But in addition to these highly talented and motivated scientists, the NITD, as part of the Novartis research family, has access to the entire Novartis compound library, its high-throughput technologies, and the help of many of the 2,700 other scientists at the Novartis Institutes for Biomedical Research–all dedicated to fulfilling the unmet needs of patients. We have established eight drug-discovery projects and our aim is to bring at least two compounds to clinical trials by 2008, and broadly make available two novel compounds by 2013. At the NITD, Novartis is applying its leading-edge scientific expertise and technology to address the medical needs of the world's poorest patients. The NITD is the first establishment of its kind to focus solely on drug discovery for these infectious diseases using modern pharmaceutical research tools. These tools include a state-of-the-art Biosafety level 3 lab, which should become a standard of excellence in the region. It is designed to allow both in vitro and whole animal studies. Beyond actually delivering new drugs to the patients who need them, we also expect that the NITD will become a model initiative contributing to a solution for the access-to-medicine problem in poor countries. This is a personal – not just professional–mission for the chairman and CEO of Novartis, Dr. Daniel Vasella, who at the age of eight was infected with tuberculosis. As he says: "Empathy is the first, and an essential reason, for creating the NITD." As a center of knowledge and education in tropical disease drug discovery, the NITD will help people in the developing world learn how to continue to address these problems in their own countries. To that end, we're pleased to report that we've attracted more than 50 excellent young scientists from 16 nations to the institute in Singapore. Initially, the NITD will focus on two major tropical diseases: dengue fever and tuberculosis. Dengue fever, which is caused by a mosquito-borne virus of the flaviridae family, has grown to epidemic proportions in many tropical regions, and currently infects about 50 million people yearly. In about 500,000 patients, mostly children, the fever progresses to often-deadly dengue hemorrhagic fever / dengue shock syndrome, which kills about 25,000 patients annually. Because there are no vaccine or antiviral drugs currently available for these patients, NITD will focus on discovering antiviral therapies for dengue virus-induced disease. Tuberculosis is caused by Mycobacterium tuberculosis and infects about one-third of humanity. It can lie dormant for years only to break out when the immune system fails, such as in AIDS patients. It develops into active tuberculosis in about 8 million patients per year, who are then highly contagious, and kills about 2 million infected patients annually. Half of the NITD scientists are dedicated to discovering antibiotics that can kill resistant tuberculosis bacteria in a shorter time frame than the currently required six to nine months, and that can destroy persistent bacteria. A MODEL FOR PUBLIC-PRIVATE PARTNERSHIPS The NITD was set up as a public-private partnership with the Economic Development Board, an arm of the Singapore government. The NITD itself is also entering many scientific partnerships on a global scale. These collaborations are essential for all the various phases of drug discovery and on through the later stages of the drug-development process. Partnerships are also necessary for successful outreach to patients, and to make treatments available to the huge number of far-flung developing countries, under affordable conditions. The Global Alliance for TB Drug Development and the Singapore Dengue Consortium represent two examples of successful NITD partnerships. The NITD has also built strong relationships with leading members of the local, regional, and global scientific and clinical communities; with international organizations, such as the World Health Organization and health ministries of the region; and with nongovernmental organizations (NGOs) such as Doctors Without Borders, also known as Medecins Sans Frontieres (MSF). THE NOVARTIS FOR TROPICAL DISEASES, SINGAPORE, has recruited scientist from all over the world It's particularly encouraging to see what used to be a predominantly antagonistic and unproductive relationship between the pharma industry and NGOs, such as MSF, becoming more constructive. For example, I am now a member of the scientific advisory board of one of MSF's initiatives, the Drugs for Neglected Diseases Initiative. MSF and the NITD have complementary and mutually needed skills: MSF knows and sees patients in parts of the world where the pharma industry is traditionally not represented, and the NITD develops drugs that MSF needs, but cannot make. It took the creation of an institute like NITD for both sides to see the advantage of a closer alliance. Even with these extensive partnerships, however, it would be unrealistic to pretend that it will be an easy road to cures or other treatments for tuberculosis and dengue fever. NITD researchers may indeed solve the scientific problems, but additional major hurdles remain for any drugs that result from this research. The stability, cost and simplicity of manufacture of such medicines, as well as mode of administration, are all important factors in tackling diseases in the developing world. To accomplish our goals, one could contend, we could have simply donated money, and not undertaken the huge effort required in setting up the NITD. We felt, however, that we could contribute best–and in a more durable fashion–with state-of-the-art drug-discovery science, one of our major strengths. We believe that with this strategy, we have something to offer the world community that is more sustainable and goes far beyond a simple monetary contribution. We are fortunate in that the world community has rapidly recognized the NITD, and we hope our fellow pharmaceutical companies will soon copy this initiative. The magnitude of the problem needs concerted effort. Paul Herrling is head of Corporate Research at Novartis and chairman of the board of the Novartis Institute for Tropical Diseases in Singapore. He also oversees the Friedrich Miescher Institute in Basel, Switzerland, serves on the board of the Genomics Institute of the Novartis Research Foundation in La Jolla, Calif., and on those of several other research institutions. He can be contacted at paul.herrling@novartis.com

Taking Aim at Neglected Diseases

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Paul Herrling

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June 2005

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