Novartis Social Business Image area The Novartis Malaria Initiative Committed to malaria control and elimination Patients are at the core of our mission to discover and develop innovative medicines. With this in mind, we have set up a holistic program to Overall, from 2001 to 2015, an estimated 6.2 million fight malaria: the Novartis Malaria Initiative. lives have been saved and the upward disease spiral reversed thanks to a concerted international Resting on four key pillars – treatment, access, effort to scale up interventions1. We are proud of capacity building, and research and development the remarkable public health milestones these – the Novartis Malaria Initiative is tailored to best collaborations have helped to achieve. meet patient needs. It has become one of the largest access-to-medicine programs in the healthcare industry, measured by the number of patients reached annually. Innovation Since 2001, working with a range of organizations, we have provided more than 750 million treatments for nt e A tm c adults and children, without profit, to more than 60 a c e e r s countries, contributing to a dramatic reduction of the T s malaria burden in Africa. R g & in d D il u b y cit Capa Partnerships Preface Image area The last 15 years have brought great progress in the Finally, adequate financing for malaria is crucial. This fight against malaria. Of the 106 countries that had funding must be available to the poorest African ongoing malaria transmission in 2000, some 102 have countries with the highest burden of disease, and met the MDG target of reversing the incidence of also to the countries that have made great progress malaria1; 57 of those have reduced malaria incidence toward elimination, but still face potential malaria by more than 75% by 2015 while a further 18 countries resurgence. Such resurgences will only be avoided have reduced malaria incidence by 50-75%2. While through ongoing investment and vigilance. we should celebrate these successes, we must also recognize and overcome key challenges that could We must build upon the extraordinary progress of slow down the current momentum. the last 15 years. With effective strategies, excellent collaboration, smart research and adequate First, emerging drug and insecticide resistance resources, we will maintain our momentum and must be actively confronted. We must therefore continue to drive toward malaria elimination, country continue our vigorous efforts to develop new drugs by country and region by region. and insecticides to respond to emerging resistance. The work of Novartis in researching and developing Our ultimate goal is nothing less than zero human the next generation antimalarials is an essential malaria on planet earth. Let us all remain focused on component of the successful fight against malaria. this common objective and intensify the collective work we have begun to ensure we see it through to its end. Second, political commitment and high ambition must be sustained. Decreased political commitment at Professor Sir Richard Feachem, either the domestic or international level would derail KBE, FREng, DSc(Med), PhD momentum. History has proven that gains in reducing Director of the Global Health Group at the malaria can be fragile, and that success can be too University of California, San Francisco easily reversed. Founding Executive Director of the Global Fund to Fight AIDS, TB and Malaria 4 | MALARIA INITIATIVE 2016 Treatment – Malaria is preventable and curable, yet it is still one of the most deadly diseases in developing countries. Although nations across Africa, where the incidence disease, with artemisinin-based combination therapies of malaria is the highest, have scaled up malaria (ACTs) as they represent the best treatment currently control strategies, effective control and treatment available2. present enormous logistical difficulties, as many at-risk populations live in extreme poverty in remote ACTs are recommended over older treatments rural areas1. Reaching remote communities with poor such as chloroquine, sulfadoxine-pyrimethamine transport systems and ensuring drug supplies do not and artemisinin monotherapies, as parasites have 2 run out represent some of the greatest hurdles to developed resistance to these drugs . The WHO malaria elimination. estimates that the number of ACT treatment courses delivered to the public and private sectors have The World Health Organization (WHO) emphasizes increased from 11 million in 2005 to 337 million in 2014 the importance of treating uncomplicated Plasmodium – of these, more than 66% were for the public sector1. falciparum malaria, the most dangerous form of the Leading the path toward malaria elimination Two decades of public health milestones License agreement signed between Novartis Novartis commits to make the fight against malaria and Chinese partners a key aspect of the company’s access-to-medicine programs 1994 1997 MALARIA INITIATIVE 2016 | 5 Image area The proportion of children under 5 years with The Novartis ACT is indicated for the treatment Plasmodium falciparum malaria who were treated of acute, uncomplicated Plasmodium falciparum with an ACT is estimated to have increased from less malaria3. It combines two antimalarial agents with than 1% in 2005 to 16% in 20141. This proportion falls complementary effects: substantially short of the target of universal access for • Artemether, a derivative of artemisinin which is malaria case management. A primary reason is that a extracted from the sweet wormwood plant Artemisia high proportion of children with fever are not taken for annua, provides fast relief from malarial symptoms care or use the informal private sector, where they are and is rapidly eliminated4. less likely to obtain ACTs for treatment.1 • Lumefantrine has a longer-lasting effect and kills residual parasites4. As this compound has never Pioneering a standard of care for millions of been deployed as a monotherapy5, the potential risk patients of resistance to lumefantrine may be lower than with other agents. In 1999, Novartis was the first healthcare company to launch a fixed-dose ACT, and in 2009 the first dispersible ACT tailored to meet the needs of children, the most vulnerable to malaria. First regulatory approvals for The Novartis ACT is the first Signed Memorandum of Understanding Novartis ACT in Africa (Gabon), one brought to market in a with the WHO to supply Novartis ACT Switzerland and UK fixed-dose form without profit to the public sector 1998-1999 1999 2001 6 | MALARIA INITIATIVE 2016 “Novartis is in the fight against malaria for the long haul. We will continue to partner with the best institutions and companies and intensify our research efforts to develop efficient compounds against malaria to eventually eliminate the disease. But we cannot do this on our own, neither as a company nor as an industry. We need support from politics, technology and academia as well as the public at large, because we can only win this fight together.” Joerg Reinhardt, Chairman of the Board of Directors of Novartis AG MALARIA INITIATIVE 2016 | 7 In 2010, Novartis was awarded the Prix Galien USA England Journal of Medicine in 2016, showed that all award in the category of the “Best Pharmaceutical the drugs had acceptable cure rates. However, AL was Agent” for its antimalarial treatment. associated with the fewest adverse effects, adding to the existing body of evidence of the safety profile of The Novartis antimalarial treatment has become a AL in pregnancy16. standard of care for millions of patients around the world: Responding to the unmet medical needs of • With a cure rate of over 95%*,6-10 and a demonstrated children safety profile6-11, this was the first fixed-dose ACT brought to market, and prequalified by the WHO for Children are the most vulnerable to malaria: in its quality, safety and efficacy12. 2015, approximately 70% of all deaths from malaria 1 • Approved in more than 60 countries, this was the occurred in children under the age of five . Malaria first and only ACT approved by the US Food and remains a major killer of children, particularly in sub- Drug Administration in 200913. Saharan Africa, taking the life of a child every two minutes.1 Over the past three years, on average, a treatment was made available to approximately 200,000 malaria Yet, until a few years ago there was no child-friendly patients every day. treatment for these vulnerable patients. Evaluating safety and efficacy in pregnant Ahead of the call from the WHO and UNICEF for “child-sized” medicines, the Novartis Malaria Initiative women started developing, in collaboration with Medicines for Malaria during pregnancy remains a significant health Malaria Venture17, a sweet-tasting ACT specifically for risk to the mother and unborn child. Malaria can cause children10. adverse outcomes, including abortion, anaemia and low infant birth weight14. Various studies to evaluate the efficacy and safety of ACTs, including artemether- lumefantrine (AL), in pregnant women have been conducted. The Novartis pediatric Two prospective studies in Zambia14 and Rwanda15, antimalarial treatment is the first: performed in collaboration with the WHO from 2004 to 2009, evaluated the safety of the Novartis ACT • Dispersible ACT specifically tailored in more than 3,000 pregnant women with malaria. Results suggested that exposure to AL in pregnancy for infants and children (≥5 kg) is not associated with particular safety risks in terms of perinatal mortality, malformations or developmental • Pediatric ACT approved by 17