Chagas Disease

DUBLIN , Feb. 8, 2024 /PRNewswire/ -- The "Chagas Disease: American trypanosomiasis Market" report has been added to ResearchAndMarkets.com's offering. The protozoan Trypanosoma cruzi is the cause of Chagas disease (CD), also known as American trypanosomiasis, a chronic, systemic, parasitic illness with substantial risk factors associated with low socioeconomic status. It is believed that Chagas sickness is a neglected tropical illness. It is widespread throughout 21 American countries, but it can spread to non-endemic nations worldwide through the movement of infected individuals. The effects of CD extend beyond Latin American rural communities where vector-borne transmission - diseases spread by insects - occurs. The epidemiology and geographic distribution of CD have changed due to significant population shifts from rural to urban areas in Latin America and other parts of the world. Control measures should concentrate on preventing transmission from organ transplants, blood transfusions and mother-to-child (congenital) transmission in the U.S. and other areas where CD is currently present but is not endemic. Treatment for T. cruzi infection can begin as soon as the infection occurs. Antiparasitic therapy may stop or slow the progression of chronic illnesses in infected people, as well as stop infections from spreading from mother to child. Two therapeutic modalities have the potential to save lives: Antiparasitic medication, which eliminates the parasite. Symptomatic therapy, which is intended to control infection-related symptoms and indicators. Treatment with antiparasitic drugs is most beneficial early in the course of infection, albeit not exclusively for acute or critical cases. There are two kinds of treatments offered in the U.S. Benznidazole is available commercially and has been licensed by the FDA for use in children ages 2 to 12. Pharmacies can buy LAMPIT (nifurtimox) commercially from several medication wholesalers. It is FDA-approved for treating children under the age of 18. Healthcare providers can consult with Centers for Disease Control and Prevention (CDC) personnel regarding patient care, and for the most part, therapy does not require hospitalization. The research report provides a thorough overview of the Chagas Disease market. This report analyzes CD market trends with epidemiological and regional markets, highlights the current market and offers a detailed competitive environment analysis. The scope of this report covers treatment throughout Latin America. The Report Includes An overview of the global chagas disease (T. cruzi infection) market Analyses of the global market trends, with historical market revenue from 2021 to 2022, estimates for 2023, forecasts for 2024, and projections of compound annual growth rates (CAGRs) through 2028 Estimate of the market size and revenue forecast for global chagas disease market, and corresponding market share analysis based on the product type, treatment, and region Overview of the significant driving trends and challenges that affect the global market and its vendor landscape Review of the epidemiology of chagas disease and potential of key marketed drugs and recent approvals Discussion of sustainability trends and factors in the chagas disease market, with emphasis on consumer attitudes, ESG score analysis, future of ESG, case study, and the ESG practices followed Analysis of the competitive intelligence based on recent developments, key financials and segmental revenues, and product launch strategies Detailed profiles of leading market participants Bayer and Insud Pharma, providing a descriptive overview of their respective businesses Key Topics Covered: Chapter 1 Introduction Chapter 2 Summary and Highlights Chapter 3 Market Overview History Trypanosoma Cruzi Vector and T. cruzi Transmission Routes Clinical Forms Future Perspectives Novel Drugs Chapter 4 Chagas Disease by Drugs Benznidazole Toxicity of Benznidazole Nifurtimox Toxicity of Nifurtimox Chapter 5 Chagas Disease by Diagnosis Serology (Antibody Detection) Molecular Testing Chapter 6 Competitive Landscape Chapter 7 Company Profiles Bayer Insud Pharma For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense) found in East and Southern Africa Paris, Geneva and Nairobi. December 15, 2023. Sanofi, DNDi and the HAT-r-ACC consortium announce the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense). This positive opinion is for the treatment in adults and children six years of age or older and weighing at least 20 kg, of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) Trypanosoma brucei (T.b.) rhodesiense sleeping sickness, an acute and lethal form of this parasitic disease found in Eastern and Southern Africa. This CHMP opinion follows an application by Sanofi under Article 58 and clinical trials in Malawi and Uganda led by the non-profit medical research organization Drugs for Neglected Diseases initiative (DNDi). The CHMP first adopted in 2018, a positive opinion of Fexinidazole Winthrop as the first all-oral treatment , in adults and children six years of age or older and weighing at least 20 kg, of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) of the more common T.b. gambiense form of sleeping sickness found in West and Central Africa. Sleeping sickness, or human African trypanosomiasis (HAT), is usually fatal without treatment. Both forms of sleeping sickness are transmitted by the bite of infected tsetse flies, which are found in 36 African countries. It causes neuropsychiatric symptoms, including aggressiveness, psychosis, a debilitating disruption of sleep patterns that have given this neglected disease its name, and ultimately, death. Dietmar Berger, MD, PhDHead of Development and Chief Medical Officer, Sanofi“The CHMP’s positive opinion is another step forward in Sanofi’s commitment to help deliver innovative treatments to vulnerable patient communities impacted by sleeping sickness, a deadly neglected tropical disease. By working with WHO and DNDi, we have made tremendous progress in improving treatment outcomes and simplifying treatment delivery. This partnership and our donation of Fexinidazole Winthrop through Foundation S, reflect our mission to provide innovative treatments to patients, no matter where they live.” For the T.b. rhodesiense variant, Fexinidazole Winthrop is indicated as a 10-day, once-daily oral treatment. Data from DNDi’s Phase 2/3 clinical trial were recently presented at the European Congress of Tropical Medicine and International Health and showed that Fexinidazole Winthrop was highly effective in treating the T.b. rhodesiense form of sleeping sickness and is a safe alternative to the existing drugs. In periodic follow-up evaluations that continued for 12 months after treatment, only one patient (2.94%) with the advanced form of the disease had relapsed and required treatment with the arsenic derivative that is the standard of care for patients with the most severe stage of the disease. Dr Westain NyirendaPrincipal Investigator and physician at Rumphi Hospital in Malawi“T.b. rhodesiense sleeping sickness is a terrifying disease that progresses more rapidly than T.b. gambiense, killing quickly if untreated. Until now, due to the lack of innovation for this strain of sleeping sickness, old and toxic treatment options have to be administered in a hospital under strict surveillance. Having a simple and safer oral pill to treat this frightening disease will allow doctors to rapidly save lives. It will also help patients to trust the new treatment.” While humans are the main host of T.b. gambiense, T.b. rhodesiense is a zoonotic disease, meaning that the infection can spread from animals to humans. Cattle and wild animals such as bushbucks and zebras are the most common reservoirs for this disease. Movements of these animals – potentially sparked by droughts or changes in climate – could put new populations at risk of T.b. rhodesiense sleeping sickness. In some cases, tourists visiting game reserves have been infected with T.b. rhodesiense. Dr Olaf Valverde MordtClinical Project Leader for sleeping sickness, DNDi“We are already seeing how an all-oral treatment for T.b. gambiense sleeping sickness has simplified the treatment of this variant in countries like the Democratic Republic of Congo. Although there are comparatively few cases of T.b. rhodesiense, last year Ethiopia recorded its first cases since the 1970s. The drought at the time of the infections brought humans and cattle in closer proximity to tsetse flies’ habitat. Environmental changes could be one of the reasons behind this resurgence.” The CHMP opinion today paves the way for the update of WHO guidelines on treatment for sleeping sickness, and distribution by WHO of Fexinidazole Winthrop in African countries where T.b. rhodesiense is prevalent. Fexinidazole Winthrop will be donated to WHO by Foundation S, Sanofi’s philanthropic organization. Dr Ibrahima Socé FallDirector of Neglected Tropical Diseases, World Health Organization “The impact of climate change extends to the shifting geographical spread of vector-borne diseases such as sleeping sickness, heightening the likelihood of spillover events where diseases transfer from animals to humans. These shifts disproportionately affect the most vulnerable communities, underscoring the urgency of sustained investment in programs addressing NTDs. This includes the development of innovative tools and improved treatment methods. We extend our gratitude to our partners DNDi for their research for the most neglected and Sanofi for their ongoing support and contribution to these vital efforts.” Fexinidazole Winthrop has already been registered in the Democratic Republic of the Congo and Uganda as a treatment for T.b. gambiense and is recommended for use in a further 10 African countries: (Angola, Burkina Faso, Central African Republic, Chad, Congo, Côte d'Ivoire, Equatorial Guinea, Gabon, Guinea, and South Sudan). Dr Michelle HelinskiSenior Project Officer for Neglected Infectious Diseases at the European and Developing Countries Clinical Trials Partnership Association (EDCTP) “We congratulate the HAT-r-ACC consortium on developing a better treatment option for this truly neglected disease and are thrilled with the positive opinion by CHMP.” The DNDi clinical trial for T.b. rhodesiense was conducted by the HAT-r-ACC Consortium, with funding from the European and Developing Countries Clinical Trials Partnership Association (EDCTP2) programme supported by the European Union; Fundação para a Ciência e a Tecnologia from Portugal; Swiss Agency for Development and Cooperation (SDC), from Switzerland; Médecins Sans Frontières International; and UK International Development, United Kingdom; and other private foundations and individuals. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY About DNDiThe Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected people. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, river blindness, mycetoma, dengue, paediatric HIV, advanced HIV disease, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health, gender equity and gender-responsive R&D, and diseases impacted by climate change. Since its creation in 2003, DNDi has joined with public and private partners across the globe to deliver twelve new treatments, saving millions of lives. dndi.org About HAT-r-ACCThe HAT-r-ACC consortium brings together a broad range of partners with expertise in sleeping sickness and capacity building in remote health settings. This research, training, and community engagement experience is essential to run the clinical trial in remote settings with a very small target population. The consortium partners include the Malawi Ministry of Health (MMoH), the Uganda National Health Research Organisation (UNHRO), the Makerere University in Uganda, Epicentre (MSF) in France, the Lisbon Institute of Hygiene and Tropical medicine (IHMT) in Portugal, the Institut de Recherche pour le Développement (IRD) in France, the WHO, and the Swiss Tropical and Public Health Institute (Swiss TPH). Sanofi Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com DNDi Media ContactFrédéric Ojardias in Geneva | +41 79 431 62 16 | fojardias@dndi.org Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release

First investment in a Japanese trading company and a Chinese pharma company. Accelerating new drug development by investing in late-phase clinical trials. TOKYO, Dec. 13, 2023 /PRNewswire/ -- The Global Health Innovative Technology (GHIT) Fund announced today an investment of approximately 1.3 billion yen (US$8.8 million1) for the development of new drugs for malaria and Chagas disease.2 Malaria is an infectious parasitic disease transmitted by mosquitos that affects approximately 250 million people annually and was responsible for approximately 620,000 deaths in 2021.3 The African region constitutes a staggering 95% of global malaria cases, and children under the age of 5 account for 80% of all malaria deaths in this region. The GHIT Fund invests in new product development with the aim of contributing to global health by facilitating collaborations between Japanese technology and innovation and global institutions to address these neglected infectious diseases. This is the first investment by the GHIT Fund in a general trading company, Marubeni Corporation (Marubeni), and a pharmaceutical company in China, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (FOSUN PHARMA), with the aim of accelerating the development of new drugs by focusing on investments in late-phase clinical trials. First investment in a Japanese trading company and a Chinese pharma company — new malaria drug in a phase III trial by Marubeni, Fosun Pharma, MORU, and MMV The GHIT Fund will invest approximately 500 million yen (US$3.3 million1) in a clinical phase III trial for a triple artemisinin combination drug against malaria, in partnership with a leading Japanese integrated trading and investment business conglomerate, Marubeni, a major Chinese pharmaceutical and health care company, FOSUN PHARMA, a Thailand-based research collaboration of universities, Mahidol-Oxford Tropical Medicine Research Unit (MORU), and the product development partnership Medicines for Malaria Venture (MMV), which provides technical support and market access expertise. This drug candidate should have a significant public health benefit as it is expected to play an important role in the fight against artemisinin partial resistance (ART-R), which is now observed widely in the Greater Mekong Subregion (GMS) of Southeast Asia4 and to some extent in several African countries, including Rwanda and Uganda. Importantly, the project includes the development of a co-formulated child-friendly version, given that most malaria cases are in children.3 800-million-yen investment in a phase IIb study of the new anti-malarial drug candidate SJ733 as a radical cure for P. vivax The GHIT Fund will also invest approximately 800 million yen (US$5.4 million1) in the anti-malarial drug project by Eisai Co., Ltd. and the University of Kentucky to develop a radical cure for P. vivax malaria. SJ733, an antimalarial drug candidate, has completed a Phase IIa trial for single administration and has shown efficacy and tolerability against P. vivax malaria. With this new investment, the project aims to shorten the treatment period by using SJ733 in combination with the existing drug tafenoquine. Dr. Osamu Kunii, CEO of the GHIT Fund, said "We are very excited to have Marubeni and FOSUN PHARMA as our new product development partners. It is an important step forward to invest in the development of antimalarial drugs in late-phase clinical trials to advance commercialization. The number of malaria cases and deaths in children under 5 years old is an urgent issue. This investment will make a significant contribution to reducing the burden of malaria globally, especially among young children." In addition, the GHIT Fund will invest approximately 16 million yen (US$0.1 million1) in Nagasaki University and Drugs for Neglected Diseases initiative (DNDi) for a screening project against Chagas disease, which is one of the neglected tropical diseases. As of December 14, 2023, there are 50 ongoing projects, including 19 discovery projects, 18 preclinical projects and 13 clinical trials5 in the GHIT Fund's portfolio. The total amount of investments since 2013 is 31.6 billion yen (US$211 million). The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. Appendix 1. Project Details G2022-205 G2022-218 S2023-121 *All amounts are listed at an exchange rate of USD1 = JPY149.52, the approximate exchange rate on October 31, 2023. Appendix 2. Investment Overview (as of December 14, 2023) Investments to date Total investments: 31.6 billion yen (US$211 million1) Total invested projects: 123 (50 active projects and 73 completed projects) To learn more about GHIT Fund's investments, please visit Investment Overview: Portfolio: Advancing Portfolio: Clinical Candidates: For more information, contact: Katy Lenard at +1-301-280-5719 or [email protected] Mina Ohata at +81-36441-2032 or [email protected] SOURCE GHIT Fund