Leading Dengue and TB scientists discuss new clinical research approaches and models of excellence for clinical research and trials in endemic regions

19.10.2009 / Basel - Novartis
NEHCRI is a unique role model for clinical TB and Dengue research in endemic regions, utilizing local input to build capacity and develop health infrastructure to treat patients that are most in need The global prevalence of Dengue has risen by 11 times since 1970[2], and globally, the WHO estimated 9.27 million incidents of TB in 2007, almost 1 million of which occurred in Indonesia[3] Basel, October 19, 2009 - Leading Dengue and TB scientists from the Novartis Institute for Tropical Diseases (NITD) are meeting today at a symposium at NEHCRI (Novartis - Eijkman Institute - Hasanuddin University Clinical Research Initiative) in Makassar, Indonesia, to discuss the initiative’s Clinical Research updates. NEHCRI is a unique collaboration comprised of a specialized network of institutes that are focused on drug discovery, capacity building and training local Indonesian scientists. "By building capacity within an endemic region, NEHCRI is becoming a model of excellence for Clinical Research," says Paul Herrling, Head of Corporate Research at Novartis and Chairman of the Novartis Institute for Tropical Diseases. "This initiative also helps establish a health infrastructure through knowledge-sharing between Novartis scientists and local Indonesian scientists. Ultimately we hope to contribute to Indonesia’s network of experienced clinicians through this integrated model." Scientists at NEHCRI are already seeing positive results of the model’s effects, including the development of two epidemiology manuscripts on tuberculosis, and implementation of translational and operational studies. The manuscripts on TB, which are currently being prepared for publication, will be essential when choosing suitable management programs for TB in Makassar. "Endemic regions - areas where patients need treatment most - are currently lacking in clinical trial capacity," says Prof Sangkot Marzuki, Director Eijkman Institute. "However, it is of critical importance to conduct clinical trials in endemic areas, so as to ensure that the treatments being tested will actually meet the real-life needs of the patients." The NEHCRI TB laboratory has the capacity to process 2,000 sputum samples per year, providing a direct impact on TB treatment. The availability of proper TB diagnostic tools provides local patients and doctors access to important resources. Indonesia currently ranks third on the list of the 22 countries with the highest-burden of TB cases across the globe, with 244 cases per 100,000 people[3]. "Success of the existing, high-quality TB diagnostic labs in Makassar is due to close collaboration among the NITD and Hasanuddin University Hospital, as well as the National TB Control Program," says Hasanuddin University Rector Prof Idrus A. Paturusi. More than 50 million cases of Dengue and 500,000 Dengue-related hospitalizations occur each year in both developed and developing regions due to the under investment in research and development for effective tools to detect and treat the disease[2]. Dengue is one of the most prevalent emerging diseases in humans with no preventative vaccines or antiviral cures available at present. The Dengue research group at NEHCRI focuses on epidemiology, virology, diagnostics and host response, as they work toward developing Dengue antiviral compounds. Within the established research setting at the Eijkman Institute of Molecular Biology in Jakarta, the NEHCRI research laboratory conducts genomic analysis of virus isolates from the clinical laboratory in Makassar. As of August 12, 2009 more than 700 cases of dengue haemorrhagic fever have been recorded in Indonesia, seven of which were fatal. The number of cases has increased compared to last year, when only 500 cases were recorded, three of which ended in deaths[4]. The NEHCRI laboratories in Makassar and Jakarta are staffed by Indonesian scientists whose experience can be applied in potential collaborations with other research groups. These partnerships could, in turn, lead to better surveillance and contribute to controlling Dengue in Indonesia. The NITD hosts events in endemic regions, such as today’s symposium at NEHCRI, to help scientists and partners understand the true impact of these diseases and the unique local challenges doctors, clinicians and patients in the region face. The NITD represents a major part of Novartis’ bid to improve the developing world’s access to medicines. The NITD’s overarching goal is to discover novel treatments and prevention methods for major tropical diseases. In those developing countries where these diseases are endemic, the Novartis Group intends to make treatments readily available without profit. The focus of the NITD is to apply Novartis’ drug-discovery expertise and cutting-edge technology platforms to fight against infectious diseases that are currently not well covered by modern treatment regimens, particularly Dengue fever and tuberculosis.

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The foregoing release contains forward-looking statements that can be identified by terminology such as "hope," "will," "work toward developing," "potential," "could," or similar expressions, or by express or implied discussions regarding the development of potential new products against Dengue or TB, or regarding potential future revenues from such products.. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Novartis will successfully develop any products against Dengue or TB, or that any such products will be submitted or approved for sale in any market. Nor can there be any guarantee that such products will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding such products could be affected by, among other things, research and development difficulties, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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[1] National Institute of Environmental Health Sciences (NIEHS), USA

Available at: www.niehs.nih.gov/

[2] Mackenzie et al., 2004

[3] World Health Organization (WHO) Global TB Report 2009.

Available at: >

[4]World Health Organization, "Dengue Fever in Indonesia."

Available at: www.who.int/csr/don/­2004_02_26a/en/index.html

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