Cécilia Conan / Image in Production PRESS KIT THE FIGHT AGAINST MALARIA: A COMPREHENSIVE COMMITMENT

Transcription

1 Cécilia Conan / Image in Production PRESS KIT THE FIGHT AGAINST MALARIA: A COMPREHENSIVE COMMITMENT APRIL 2014

2 CONTENTS Key figures Half the world s population is exposed to malaria Sanofi s commitment to the fight against malaria» Making medicines more affordable through tiered pricing» Information, training and education programs with local organizations (Schoolchildren against Malaria, MOSKI KIT)» Innovating to respond to future needs Burkina Faso: overview Organization of the Burkina Faso health system Sanofi: more than 50 years of commitment in Africa Sanofi s Access to Medicines Sanofi Appendix: Malaria in Burkina Faso

3 KEY FIGURES MALARIA 207 million cases reported in 2012 (1) 50 % of the global population exposed to malaria (1) 627,000 deaths worldwide in 2012, 90% in Africa (1) 77 % of victims are children under five (2) Most deaths occur among children living in Africa, where malaria kills one child every minute (1). MALARIA IN BURKINA FASO In 2013, 6,900,203 cases of malaria were recorded in Burkina Faso, including 406,103 cases of severe malaria. The cumulative incidence was 398 cases per 1,000 inhabitants, a decrease from the 2012 level of 415 cases per 1,000 inhabitants. Over the past five years, malaria has been the primary reason for medical consultation and hospitalization. It has also been the leading cause of death at healthcare facilities. NMCP data (1) WHO - Media Center Fact sheet No. 94 Malaria - March (2) WHO, WHO Global Malaria Program, World Malaria Report

4 KEY FIGURES DEVELOPMENT OF ASAQ Winthrop Dates 2001 WHO recommends Artemisinin-based combination therapies (ACTs), to fight malaria 2004 Partnership agreement between independent non-profit foundation DNDi (Drugs for Neglected Diseases initiative) and Sanofi to develop ASAQ Winthrop, a fixed-dose combination of Artesunate and Amodiaquine 2007 Introduction on the market of ASAQ Winthrop, manufactured and packed at Sanofi s Morocco plant 2008 WHO pre-qualification of ASAQ Winthrop 2010 Sanofi receives the 2010 Global Business Coalition Core Competence Award for its innovative partnership to provide access to anti-malaria medicines 2012 The production process for semi-synthetic Artemisinin receives the Pierre Potier Prize for innovation in chemistry that promotes sustainable development 2014 Sanofi and DNDi receive the Corporate Social Responsibility Excellence award from the Association of Strategic Alliance Professionals (ASAP) on March 12. The award recognizes «the significant and measurable positive social impact» of 10 years of public-private partnership in the fight against malaria. Figures ASAQ Winthrop is registered in 33 countries including 30 in Africa More than 280 million treatments have been distributed since 2007, with 80 million in 2013 Of the 80 million treatments distributed in 2013, 33% were adult dosages, 52% were for children and 15% for infants The five leading beneficiary countries: Democratic Republic of Congo, Nigeria, Burkina Faso, Sierra Leone and Ghana. 2

5 HALF THE WORLD S POPULATION IS EXPOSED TO MALARIA Nearly half of the global population is exposed to malaria, the world s most common and deadly parasitic disease. In 2012, according to WHO, 80% of 207 million reported cases and 90% of 627,000 deaths from malaria occurred in Africa. Seventeen countries account for 80% of the deaths, with 40% from the Democratic Republic of Congo and Nigeria. The global malaria mortality rates are estimated to have decreased by 42% across all age groups between 2000 and 2012, and by 48% in children under 5 years old (3). Early treatment A parasite of the Plasmodium genus is the source of malaria. It is transmitted through the bite of the Anopheles mosquito. Once in the blood, it colonizes and destroys red blood cells causing malaria attacks, with symptoms that include sudden fever, fatigue, headache, chills and vomiting. Five species of Plasmodium have been identified, the most virulent being Plasmodium falciparum, which is especially prevalent in Africa. The malaria episode begins between eight and 30 days after infection, but initial symptoms are sometimes mild and difficult to identify. Plasmodium falciparum malaria must be treated quickly or else it rapidly becomes serious, leading to severe anemia, convulsions and coma, causing irreversible damage and sometimes death. Other forms of relatively severe malaria due to Plasmodium vivax have also been observed, especially in Bangladesh, India and Latin America. Early diagnosis and treatment can reduce the intensity of the disease, preventing it from becoming fatal and reducing transmission. Since 2001, WHO has recommended Artemisinin-based Combination Therapy (ACT), which reduces the risk of resistance to treatment. The fight against malaria also involves the use of insecticide-treated bed nets. Economic impact Beyond the major impact on public health, malaria has significant consequences for the economies of countries affected by the disease, as well as in terms of lost work days, school absenteeism and decreased purchasing power of families: a quarter of African households income and 1.3% of annual growth is lost each year. Costs associated with the disease can also represent up to 40% of public health expenditures, 30-50% of hospital admissions and 50% of outpatient visits. Julien Chraïbi (3) WHO, WHO Global Malaria Program, World Malaria Report

6 SANOFI S COMMITMENT TO THE FIGHT AGAINST MALARIA Sanofi is committed to improving access to health care for the poorest populations in developing countries. Its Access to Medicines department develops sustainable models for providing quality care to the neediest patients for diseases like malaria where the company has recognized expertise. Sanofi s approach is part of a comprehensive initiative that includes partnerships with local organizations, tiered pricing to make medicines affordable and information, training and education. Sanofi also researches and innovates to meet future needs. Tiered pricing to make medicines affordable The development and introduction of ASAQ Winthrop (Artesunate-Amodiaquine Winthrop combination) in 2007 resulted from a partnership initiated in 2004 between Sanofi and the non-governmental organization DNDi (Drugs for Neglected Diseases initiative). This fixed combination reduces the number of tablets required to be taken daily, facilitating compliance. The dose is one tablet per day for three days for infants and children, and two tablets per day for three days for adults. Four presentations are available according to age and weight. The tablets are soluble in water making them more suited to children. To make them accessible to all, Sanofi and DNDi chose not to protect the ASAQ Winthrop patent. Treatment is available to the public at a cost below $1 for adults and $0.50 for children for three days of treatment. These price levels have become the reference for all ACT manufacturers. Since 2007, more than 280 million treatments have been distributed, mainly in Africa. ASAQ Winthrop is now registered in 33 countries, 30 of which are in Africa. ASAQ Winthrop is WHO prequalified and manufactured by Sanofi in Morocco In 2008, ASAQ Winthrop was the first fixed ACT combination to be pre-qualified by the WHO, enabling quality medicines to be rapidly made available, mainly in the areas of HIV/AIDS, malaria and tuberculosis. Medicines meeting the WHO quality requirements are included on a list of «pre-qualified» drugs: initially intended for UN drug procurement agencies, the list has become an important tool for other large agencies responsible for drug purchases. This prequalification has contributed to the rapid uptake of ASAQ Winthrop which, in seven years, has helped treat more than 280 million malaria episodes. ASAQ is manufactured at Sanofi s Zenata plant in Morocco, with 100 million treatments produced in Nearly a third of the world population does not yet have access to essential healthcare. As a global healthcare leader, Sanofi has the expertise and resources to improve access to healthcare for the most disadvantaged populations. This approach is at the heart of our corporate social responsibility strategy, and it is the mission of the Access to Medicines team. This approach includes tiered pricing policies to make medicines accessible, but also information and education programs targeting the key stakeholders. Our malaria program is a good illustration of this strategy. Dr. Robert Sebbag, Vice President, Sanofi Access to Medicines 4

7 SANOFI S COMMITMENT TO THE FIGHT AGAINST MALARIA Information, training and education with local organizations Beyond treatment, Sanofi develops programs with local stakeholders to train healthcare professionals, inform communities and educate patients. Scientists and managers from the National Malaria Control Program (NMCPs) have worked to develop comprehensive information on the prevention, diagnosis and management of malaria. For example, Sanofi helped set-up an Inter-University Degree in Pharmaceutical Supply Management in HIV, Tuberculosis and Malaria control in sub-saharan Africa at the University of Ouagadougou. This training for pharmacists and other pharmacy staff serving in sub-saharan Africa, helps to improve the management of drug supplies related to the three priority diseases of HIV, tuberculosis and malaria. This is the first French language post-graduate diploma on this subject in Africa. Rémi DUHAMEL / Image in Production Raising awareness through Schoolchildren against Malaria The Schoolchildren against Malaria program provides educational tools for teachers and has helped to raise awareness for more than 3.6 million children between 2008 and 2013 in Burkina Faso, Burundi, Côte d Ivoire, Ghana, Kenya, Madagascar, Niger, Nigeria and the Democratic Republic of Congo. As part of this initiative, the MOSKI KIT is an edutainment tool, allowing children to learn while having fun. It was designed with the help of various partners in the field, including the National Malaria Control Programs (NMCPs), NGOs and schools. The key messages were developed from NMCP training modules with illustrations designed to reflect the daily lives of children to facilitate understanding of the messages. The MOSKI KIT has been successfully implemented in several African countries, including Niger, the Democratic Republic of Congo, Kenya, Nigeria, Ghana and Côte d Ivoire. 5

8 SANOFI S COMMITMENT TO THE FIGHT AGAINST MALARIA Treatment is only part of the solution. We must also contribute to our partners efforts on prevention, diagnosis and treatment of the disease. To do this, information, communication and education at all levels of the medical pyramid is crucial: with children and parents, extended families, community workers and specialists. Dr. François Bompart, Deputy Director and Medical Director - Sanofi Access to Medicines Successful partnership between Sanofi and the NGO JEREMI Since 2007, Sanofi s Access to Medicines malaria program has cooperated with the NGO JEREMI Dijon in the fight against malaria in Burkina Faso s Ouahigouya district. The collaboration includes technical and financial support as well as the ongoing exchange of ideas and experiences as part of a community-based program. These joint efforts have led to a significant reduction in the disease s prevalence in the Tangaye region in only two years. The project covers 110,000 inhabitants, including 30,000 in rural areas and 80,000 in urban areas, with a priority on treating pregnant women and children under five. Julien Chraïbi 6

9 SANOFI S COMMITMENT TO THE FIGHT AGAINST MALARIA Innovating to meet future needs An innovative industrial process Global demand for Artemisinin, a key substance for Artemisinin-based combination therapies (ACT), has increased since the WHO recommended ACTs in the treatment of malaria. As the supply of natural Artemisinin (derived from the wormwood plant) does not always meet demand, development of a new industrial manufacturing process was initiated 10 years ago. This very innovative project was funded by the Bill and Melinda Gates Foundation and implemented via a partnership led by PATH (formerly OneWorld Health Institute), and involving the University of Berkeley, California, Amyris and Sanofi. In 2013, research led to the production of semi-synthetic Artemisinin at Sanofi s Garessio site, Italy. In December 2012, the process won the Pierre Potier Award for innovation in chemistry for sustainable development. It has many benefits: consistent quality, production time reduced to four months (1/3 of the time that it used to take) and the minimization of shortage risks. Sanofi is also committed to maintaining the price of semi-synthetic Artemisinin to levels acceptable for public health agencies in developing countries. Beginning in 2014, Sanofi s goal is to produce an average of tons of Artemisinin (35 tons in 2013), ensuring the production of 80 to 150 million ACT treatments. The search continues Antimalarial drugs are widely used but rarely the subject of post-marketing studies to assess their safety and effectiveness under real use conditions. A field monitoring program of ASAQ Winthrop is being implemented in collaboration with WHO. Sanofi also signed an agreement with Medicines for Malaria Venture (MMV) in 2009 to conduct the largest ever study of an antimalarial drug, involving detailed analysis of data from more than 10 monitoring and pharmacovigilance studies grouped within the same database. One of the priorities of ongoing research is finding means of fighting against resistance to existing treatments. In 2012, Sanofi decided to share with WWARN (WorldWide Antimalarial Resistance Network) all data collected through clinical trials in order to monitor emerging resistance in Southeast Asia. Such trends may pose a risk to global public health as there is no new family of drugs available to replace existing treatments. François Terrier 7

10 BURKINA FASO OVERVIEW Population: 16,460,000 inhabitants in 2012 TUNISIE Location: Burkina Faso is located in West Africa. It is surrounded by Mali to the northwest, Niger to the northeast, Benin to the southeast and Togo, Ghana and Côte d Ivoire to the south SÉNÉGAL MAROC AFRIQUE DE L OUEST ALGÉRIE BURKINA FASO LIBYE ÉGYPTE SOUDAN Area: 273,187 km 2 (about half the size of France) NIGERIA CAMEROUN AFRIQUE DU NORD-EST Capital: Ouagadougou (1,915,102 inhabitants in 2012) AFRIQUE CENTRALE Second largest city: Bobo-Dioulasso 77% of the population lives in rural areas 44% of the population lives below the poverty line AFRIQUE DU SUD-EST Languages: French, Moore, Dioula and Fulfulde AFRIQUE DU SUD 2012 GDP: 5,658.9 billion of FCFA +8% Per capita GDP: 335,812 FCFA 2012 gross national income per capita: 1,490 dollars 2012 inflation rate: +3,8 % Health expenditure per capita 81 dollars in 2011, representing 6.5% of GDP Life expectancy at birth: 54 for men and 57 for women (2011) Infant mortality rate: 102 per 1,000 live births (2012) - National Institute of Statistics and Demography ( 8

11 ORGANIZATION OF THE BURKINA FASO HEALTH SYSTEM Burkina Faso has one doctor per 25,696 inhabitants, compared with the recommended WHO standard of one doctor per 10,000 inhabitants. The country has one nurse for every 2,817 inhabitants. The share of the state budget allocated to the Department of Health increased from 9.1% in 2011 to 12.5% in Burkina Faso is divided into 13 administrative regions, 45 provinces, 70 health districts and 351 urban and rural municipalities. The Ministry of Health is structured in three levels - central, regional and district levels. To meet the country s needs, there are three university hospitals and a national hospital, nine regional hospitals, 44 district hospitals and 1,443 health centers. Health services for the rural population is limited to primary care Julien Chraïbi centers that employ two nurses and a midwife. The private sector includes about 450 for-profit institutions, 45 non-governmental organizations (NGOs) and faith-based health centers and 140 biomedical laboratories. The National Malaria Control Program (NMCP) is a unit within the Ministry of Health, which is part of the Disease Control department, with three doctors, a pharmacist and 17 employees. Four research centers are engaged in malaria research: the National Center for Research and Training on Malaria, the Research Institute of Health Science, the Muraz Center and the Nouna Center for Health Research. The NMCP, following the guidelines of the WHO, has initiated the development and implementation of a program of community home based care for simple malaria (called PECADO in French). This program is based on training community health workers who work to improve community awareness on prevention, provide diagnosis and treat simple malaria with ACTs. 9

12 SANOFI: MORE THAN 50 YEARS OF COMMITMENT IN AFRICA ALGERIA TUNISIA MOROCCO ALGERIA LIBYA EGYPT A historical presence, an innovative approach 1931: Subsidiary in South Africa SENEGAL WEST AFRICA SUDAN 1961: Plant in Egypt NORTHEAST AFRICA 1972: Plant in South Africa 1994: Medical research award in Tunisia NIGERIA CAMEROON CENTRAL AFRICA 2000: Gaucher initiative program in Egypt 2001: Malaria program Access to Medicines 2010: e-diabetes program 8 subsidiaries 7 plants SOUTHEAST AFRICA Preventative and treatment solutions as well as adapted programs for access to care The company offers a wide range of products adapted to meet the needs of people in Africa through its different entities: Sanofi:» communicable diseases» non-communicable diseases» consumer healthcare Sanofi Pasteur: vaccines Genzyme: rare diseases Zentiva: generics Merial: animal health A major industrial presence SOUTH AFRICA 60% of products distributed by Sanofi in Africa are locally produced 80M in industrial investment during the past five years and 120M planned in next five years Sanofi s strong industrial footprint brings it closer to the needs of African patients and carries major competitive advantages: better understanding of markets, responsiveness to the needs of calls for tenders and populations and the quality of its therapeutic offer. A SANOFI COMPANY A SANOFI COMPANY A SANOFI COMPANY APPROXIMATELY 60% OF PRODUCTS DISTRIBUTED BY SANOFI IN AFRICA ARE LOCALY PRODUCED 80 M IN INDUSTRIAL INVESTMENT DURING THE PAST FIVE YEARS AND 120M PLANNED IN NEXT FIVE YEARS Sanofi deploys access to healthcare programs in Africa. In 2012, we conducted 92 programs in 34 countries. These programs enabled the training of 24,000 health professionals and benefited 87 million Africans. 4,680 employees 98% of employees are African, 74% hold advanced degrees Sanofi believes that sharing expertise through training and employment of local teams contributes as much to economic development as to improving the health of patients. 98% OF EMPLOYEES ARE AFRICAN 74% HOLD ADVANCED DEGREES (4) (4) Figures unavailable for Morocco and South Africa 10

13 ACCESS TO MEDICINES AT SANOFI To promote access to health care for the poorest patients in developing countries, Sanofi has created a dedicated unit: the Access to Medicines department (ATM). ATM focuses on diseases for which Sanofi has recognized expertise based on its drug The programs focus on therapeutic areas in which Sanofi has recognized expertise, including malaria, tuberculosis, neglected tropical diseases, mental disorders and epilepsy. portfolio: malaria, tuberculosis, neglected tropical The initiatives are part of a holistic approach that diseases (sleeping sickness, leishmaniasis, Chagas works on several levels: disease, Buruli ulcer), epilepsy and mental disorders.» Develop tiered pricing policies, in agreement with All initiatives are integrated into a comprehensive the governments of countries where Sanofi provides approach designed to operate at multiple levels: its support, making our medicines affordable for» patients most in need; In the early stages of drug development, with an emphasis on research programs;» In the field, providing information and promoting education and prevention;» Through a tiered pricing policy, designed to make medicines affordable for all;» Within communities, working with local partners.» Propose solutions in the field adapted to community needs, working alongside local partners;» Develop information, education and communication programs to train heathcare professionals, to inform communities and educate patients about the prevention, diagnosis and treatment of these diseases; Sanofi also relies on the actions of the Fondation Sanofi» Espoir, whose goal is to reduce health inequality in the to provide medicines customized to the needs of world s poorest communities. populations and anticipate future needs. This Strengthen research and development in order approach makes use of Sanofi s expertise and resources in covered countries, in particular to produce quality medicines close to the communities Julien Chraïbi that need them. - Institut national de la statistique et de la démographie ( 11

14 SANOFI Sanofi is a global healthcare company focused on patient needs and engaged in the research, development, manufacturing and marketing of healthcare products. The Sanofi Group is organized around three principal activities: Pharmaceuticals, Human Vaccines via Sanofi Pasteur and Animal Health via Merial Limited (Merial) of which we are world leaders. As a global diversified healthcare company our business includes a diversified offering of medicines, consumer healthcare products, generics, animal health and human vaccines. As a leading healthcare company, Sanofi s mission is to protect the health, improve the quality of life and meet the hopes and potential needs of 7 billion people in the world. We are present in approximately 100 countries on five continents with 112,128 employees at year end In 2013, net sales amounted to 32,951 million euros. We are the third largest pharmaceutical group in the world and the second largest pharmaceutical group in Europe (source: IMS sales 2013). 12

15 APPENDIX: Malaria in Burkina Faso The number of malaria cases recorded in 2013 was 6,900,203, with 406,103 cases of severe malaria. The cumulative incidence of 398 cases per 1,000 inhabitants decreased from the 415 cases per 1,000 inhabitants in The rising incidence between 2008 and 2012 may be a result of an increased use of health facilities by the population. Over the past five years, malaria has been the primary reason for medical consultation and hospitalization. It has also been the leading cause of deaths at healthcare facilities. In 2012, malaria cases represented 45.9% of consultations, 52.3% of hospitalizations and 36.4% of deaths. The malaria mortality rate dropped from 1.8% in 2012 down to 1.4 % in Factors that may explain this decrease include training of health workers on the management of malaria and the providing to health districts of rapid diagnostic tests and emergency kits for the management of severe malaria in children under five and pregnant women. Number of reported cases in health facilities in Burkina Faso from 2006 to 2013 Evolution in malaria incidence (per 1,000 inhabitants) in Burkina Faso ( ) Evolution in overall malaria mortality in Burkina Faso ( ) NMCP data

16 Laurence Bollack Senior Director, Media Relations Corporate Communications CELL