Le sfide della nuova cooperazione: il diritto alla salute Audino Podda

Emerging and re-emerging infectious diseases 2 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

Children from developing countries pay the biggest toll 99% of DALYs and 96.5% of deaths due to infectious diseases are in low & middle income countries 53% of DALYs from infectious diseases are in children <5 years of age 43% of deaths from infectious diseases are in children <5 years of age 70% of DALYs from infectious diseases in children <5 years of age are from diseases for which no vaccines are available 3 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

Access to Medicines in developing countries Medicines of the rich world are only partly accessible for poorer populations Cost Distribution Education, compliance, cultural differences Lack of research into diseases endemic in poorer countries Others like: clean water, hygiene Pharma companies traditionally invested only where large markets existed Developed societies have evolved to accept some responsibility for the developing world Pharma shareholders accept that part of the profits are allocated to alleviate the access to medicine problem 4 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

Access to Medicines Options for Pharma Companies Money Mostly wasted Existing drugs at cost / free Useful Discovery of new medicines1 Great need Training of discovery scientists Useful Education of patients and health workers Necessary Distribution Necessary Medical treatment on site Necessary 1 Leveraging modern drug discovery science and technologies for neglected diseases 5 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

Novartis access to medicines programs 79 Novartis access to medicines programs 79.5 million patients supported in 2009 Coartem® subsidized 84 million treatments shipped – cumulatively delivered 300 million treatments, helping to save about 750,000 lives 2009 Programs and research valued at USD 1.5 bn3 Contributed 3% of net sales Leprosy medication free of charge >4.5 million patients cured since 2000 Tuberculosis medicine donations 500,000 treatments committed, 50% delivered Glivec® patient assistance Free to >37,000 patients in about 80 countries NITD1 in Singapore Focus on tuberculosis, dengue fever and malaria Recognizing the urgent medical need Novartis wanted to contribute new medicines to poor patients, in addition to donating therapies in its pipeline. Novartis works to ensure that life-saving medicines are accessible to patients in a variety of ways. We are fighting leprosy, malaria and tuberculosis in developing countries through an innovative partnership with the WHO. We offer our innovative cancer medicine, Glivec, free to patients who would otherwise not be able to afford it. We also work to break down barriers to access, including access to treatment centers and acceptability of treatment, through the Novartis Foundation for Sustainable Development. Two nonprofit research institutes, NITD and NVGH, research neglected diseases of the developing world, and commit to make treatments available to patients in poor countries without profit. Even in the economic downturn during 2009, Novartis continued its commitment to support patients by contributing 3% of net sales to access-to-medicine programs. Novartis therefore decided in 2001 to allocate some of its research and technology resources to address neglected diseases normally not taken up by commercial Pharma companies as a further significant contribution to the solution of the problem of access to medicine in the developing world NVGH2 in Siena, Italy Vaccines research institute for neglected diseases 1Novartis Institute for Tropical Diseases; 2Novartis Vaccines Institute for Global Health; 3Based on approximate market value 6 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only 6

Novartis Vaccines Institute for Global Health Siena, Italy Subsidiary of Novartis AG Part of Novartis Institute for Biomedical Research (NIBR) Co-located in Siena with Novartis Vaccines & Diagnostics Started operations in February 2008 Currently ~40 staff and students 7 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

NVGH Mission & Role To develop effective and affordable vaccines for neglected infectious diseases of developing countries .... .....Starting from an idea produced in a laboratory through assessment of the clinical profile in humans and final transfer of the vaccine to a manufacturer 8 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

Which diseases cause the greatest burden Which diseases cause the greatest burden? DALYs from diseases for which vaccines are not available in children <5 years Other Lower respiratory Malaria Diarrhea HIV 35% of DALYs are caused by diarrheal diseases STD (not HIV) WHO 2008 Global Burden of Disease http://www.who.int/healthinfo/global_burden_disease/en/index.html 9 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

Initial NVGH Vaccine Development Programs Focus on diarrheal diseases To develop effective and affordable glyco-conjugate vaccines for Salmonella related diseases. Currently in development are: Vaccine against Salmonella enterica serovar Typhi (Typhoid vaccine) Vaccine against S. Typhi & S. Paratyphi A (Bivalent vaccine) Vaccine against S. Typhimurium and S. Enteritidis [Non-Typhoidal Salmonella (“NTS”) vaccine] To develop an effective and affordable pan-specific protein- based vaccine against Shigella related diseases  10 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

The NVGH Typhoid Vaccine Global Relevance of Typhoid Fever Typhoid Fever is a recognized global health issue There are about 20 million cases of typhoid fever causing 200,000 to 600,000 deaths worldwide each year To these numbers should be added at least another 5 million cases of paratyphoid fever High disease incidence in under 5 year old children Development of antibiotic resistance (which makes treatment of the disease more difficult) is an additional cause for concern 90% of cases and deaths in Asia (mostly South & South East Asia) Crump et al, Bull WHO 2004 11 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

The NVGH Vi-CRM197 vaccine Clinical development A Phase 1 trial is currently ongoing in Europe to compare the safety and the immunogenicity of the conjugate vaccine with the licensed polysaccharide vaccine Preliminary Results Conjugate vaccine is very immunogenic (Antibody levels are six times higher than with polysaccharide vaccine) Conjugate vaccine is safe (No serious adverse events reported) Age de-escalation trials are planned to start in Asia by the end of the year Phase 1 Antibody response 12 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

NVGH Education Programs PhD programs for post graduate students from developed & developing countries Stages and MSc opportunities Exchange programs Vaccinology Masters for MD’s from developing countries 13 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

Masters in Vaccinology & Pharmaceutical Clinical Development Two year program jointly sponsored by the University of Siena Medical School, NV&D and NVGH. The program teaches specific topics in the field of vaccinology and clinical development and provides an extensive practical training The Masters is an important opportunity for young physicians from developing countries to become well trained clinical investigators and be involved in the testing of new vaccines going back to their countries Additionally, the students are prepared for a possible career in public health and vaccine development within academic institutions or the pharmaceutical industry 14 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

Vaccinology Masters: students’ countries Ghana Cameroun Pakistan Nepal Philippines Ethiopia Nigeria Uganda Kenya Tanzania Zambia 15 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

Conclusion Novartis is a leading contributor to the medical needs of poor patients all over the world Projects include making accessible medicines in its pipeline for leprosy, tuberculosis and malaria It has dedicated two discovery institutes to neglected diseases of the poor (one of which is NVGH) It contributes to the education of healthcare personnel and patients in the developing world It fosters an open debate on corporate social responsibility and sensitizes affluent societies to the needs of poorer ones. 16 | Cooperazione Internazionale e Pace | Pontedera | Audino Podda | October 2010 | Business Use Only

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