Lumefantrine

SHANGHAI, April 26, 2024 /PRNewswire/ -- World Malaria Day is marked each year on April 25. World Health Organization (WHO) gave as the theme for World Malaria Day 2024 Accelerating the fight against malaria for a more equitable world. WHO stated that malaria not only continues to directly endanger health and cost lives, but it also perpetuates a vicious cycle of inequity. People living in the most vulnerable situations including pregnant women and children under 5 years of age continue to be disproportionately impacted. Artemisinin medicines developed with China's scientific research efforts have become a ticket for China's innovative medicines to go global. According to the WHO World Malaria Report 2023, globally in 2022, there were an estimated 249 million malaria cases and 608,000 malaria deaths. Sub-Saharan Africa accounted for more than 95% of the global malaria cases and deaths. Globally, an estimated 11.7 million malaria deaths were averted in the period 2000-2022. Among them, the average malaria mortality rate (number of deaths per 100,000 population at risk) in Africa decreased from 0.14% per 100,000 population to 0.055%, from 142.6 per 100,000 population in 2020 to 55.5 in 2022. The widespread use of artemisinin medicines is one of the key success factors. Several global multi-center phase III clinical studies and real-world data have shown that artesunate injection is effective in reducing malaria mortality rate. Self-developed Artemisinin medicines covering from prevention to severe disease treatment As a leading global R&D and production enterprise of anti-malaria drugs, anti-malaria drugs produced under the R&D and innovation of Fosun Pharma cover malaria prevention, general malaria treatment and severe malaria treatment. A total of 33 products in the anti-malaria series were approved by WHO pre-qualification (WHO PQ), which have made significant contribution to malaria prevention and treatment in countries and regions such as Africa. In 2010, Artesun®, an artesunate for injection independently developed and manufactured by Fosun Pharma, was approved by WHO PQ. Since 2011, it has been recommended by WHO as a first-line drug for the treatment of severe malaria in children and adults. At the same time, Fosun Pharma is also a supplier of anti-malaria drugs of the Global Fund, UNICEF, WHO and African governments. By the end of 2023, Fosun Pharma has supplied over 340 million doses of artesunate for injection across the world, treating more than 68 million severe malaria patients worldwide. Meanwhile, Fosun Pharma went deep into the remote areas of African villages and meet the needs of clinicians through continuous innovation. Through process optimization, it has independently developed and launched the second generation of artesunate injection (trade name: Argesun®), which is the first one-step preparation passing the WHO PQ in the world. The preparation time of the drug was reduced from 3 minutes to 1 minute, which can save the time for treating patients with severe malaria. Meanwhile, the concentration of Argesun® was standardized for intravenous and intramuscular injections, which makes it more convenient and safer for clinical purposes. Artemisinin-based combination therapies (ACTs) are recognized by WHO as the best available treatment. However, in recent years, drug resistance to these therapies has also begun to emerge in Plasmodium falciparum, which is becoming a major threat to malaria control. The global multicenter Phase III clinical trial project led by Fosun Pharma for a triple artemisinin combination drug (Artemether-Lumefantrine-Amodiaquine fixed-dose formulation) against malaria in Africa and Southeast Asia has also received attention from all parties, and the Japan-based Global Health Innovative Technology Fund (GHIT Fund) announced in December 2023 that it will invest approximately US$3.3 million (approximately 500 million yen[1]), to accelerate the development and commercialization of this new drug. 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 Asia[2] and to some extent in several African countries, including Rwanda and Uganda. Further improving the accessibility of second generation of Artesunate for injection to benefit remote areas of Africa From April 21 to 27, the 8th Multilateral Initiative on Malaria (MIM) Pan-African Malaria Conference was held in Kigali-Rwanda. As one of the main sponsors of the conference, Fosun Pharma showcased its full range of antimalarial products and successfully hosted the academic symposium "Improving antimalarial treatment for severe P. falciparum malaria" on April 23. The symposium introduced the recent trends in the global and particularly African burden of severe malaria and the latest treatment and clinical management strategies to over 300 malaria researchers, clinicians, malaria control officials, and NGO representatives from Africa and around the world. The session was co-chaired by Professor Olugbenga A Mokuolu from Nigeria (Co-Chair of RBM Case Management Working Group; Strategic Adviser on Malaria Elimination to the Honorable Minister of Health Nigeria) and Professor Marielle Bouyou Akotet from the Université des Sciences de la Santé Gabon. Professor Arjen Dondorp and Professor Joel Tarning from the University of Oxford, and Dr. Samwel Gesase from the National Institute for Medical Research in Tanzania, respectively, presented the important contributions of injectable artesunate in the treatment of severe malaria patients from the epidemiological, clinical pharmacological, and pharmacoeconomic perspectives. They also highlighted the clinical advantages of Fosun Pharma's second-generation of artesunate injection with one-step preparation in the management of severe malaria. The 1.5 hours scientific session was ended by an introduction of the post-discharge malaria chemoprevention, PDMC by Professor Kamija Phiri from Kamuzu University of Health Sciences Malawi. The attendees highly appreciated the academic professionalism of Fosun Pharma's symposium on severe malaria and recognized Fosun Pharma's commitment to affordable innovation in bringing a new generation of artesunate injection with one-step preparation to Africa. The experts agreed that " artesunate injection is currently the most effective drug for the treatment of severe malaria. The new generation of artesunate injection with one-step preparation will further enhance the convenience of clinical use and reduce the clinical cost of severe malaria treatment, benefiting critically ill children with malaria in remote areas of Africa where medical conditions are poor." From treatment to prevention, effectively reducing the incidence of severe malaria in children According to the WHO, children under 5 years old are still the most vulnerable population to malaria infection. in 2022, an estimated 4 out of 5 malaria-related deaths in the African Region were among children under 5 years of age. Inequities in access to education and financial resources further exacerbates risk: children under 5 years of age from the poorest households in sub-Saharan Africa are 5 times more likely to be infected with malaria than those from the wealthiest households. To improve this situation, Fosun Pharma, in collaboration with the National Malaria Control Program in Africa, continued to carry out the "Promoting Malaria Prevention Knowledge among Children Program" in 14 malaria-prone countries in Africa, targeting at the community level, in order to raise the awareness of malaria prevention among the local population in Africa, and to help reduce the incidence rate of malaria and interrupt the transmission of malaria in the community. In August 2018, Fosun Pharma's SPAQ-CO® Disp (co-packed sulfadoxine-pyrimethamine dispersible tablets and amodiaquine dispersible tablets), for the prevention of malaria in children, was approved by WHO PQ . By the end of 2023, more than 258 million children in Africa had benefited from the "Seasonal Malaria Chemoprevention Program", for which SPAQ-CO® Disp is used as the core drug, effectively reducing the incidence of malaria in children under five years old in Africa. Promoting the localization of pharmaceutical production and helping to enhance the healthcare capacity of developing countries Based in China and with a global presence, Fosun Pharma has always been committed to providing high-quality medical solutions to patients worldwide. It actively expands its business in emerging markets, including Africa, India and Southeast Asia, to improve the accessibility of medicines in developing countries. By the end of 2023, Fosun Pharma had established five regional distribution centers in emerging markets. The overseas commercialization team consists of approximately 1,000 people, dedicated to enhancing the accessibility of pharmaceutical products. To achieve localized pharmaceutical manufacturing and supply in Africa and to enhance the accessibility and affordability of pharmaceutical and healthcare products in the African region, Fosun Pharma's Cote d'Ivoire park project was initiated in November 2022. The project is planned to be carried out in three phases, with the first phase expected to be completed in 2024. Upon completion of the project, the production capacity of the park will be expanded to 5 billion tablets per year and include a warehouse with a storage capacity of 10,000 pallets, which is expected to bring nearly 1,000 job opportunities to the Greater Bassam area and effectively promote the development of the pharmaceutical industry in Cote d'Ivoire. About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products. Fosun Pharma's innovative products mainly covered core therapeutic areas such as tumors (solid tumors and hematologic tumors), immunology, central nervous system, and chronic diseases (liver disease/metabolism/kidney disease). Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of "Innovation Transformation, Integrated Operation and Steady Growth", with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global pharmaceutical and healthcare markets. For more information, please visit our official website: SOURCE Fosun Pharma

There is currently no evidence-based treatment for the smallest babies with malaria The CALINA study tested a new ratio and dose of Coartem® (artemether- lumefantrine) to account for metabolic differences in babies under 5 kg The CALINA trial indicated that the new formulation has good efficacy and safety, and the data have been submitted for regulatory review Basel, April 24, 2024 – Novartis and Medicines for Malaria Venture (MMV) announce positive data from their phase II/III CALINA study, demonstrating that a novel formulation of Coartem® (artemether-lumefantrine) developed for babies weighing less than 5kg with malaria has the required pharmacokinetic profile and good efficacy and safety. The trial was conducted in several African countries. The data, which will be presented this week at the Multilateral Initiative on Malaria (MIM Society) 8th Pan-African Malaria Conference in Kigali, have been submitted for regulatory review. Malaria exerts a massive burden on public health across the world, particularly in Africa1. Huge strides have been made in recent decades in the treatment of malaria. However, to date, little data has been generated in the smallest children – babies less than 5 kg. “We are pleased with the positive outcomes from our CALINA study and to be one step closer to bringing an effective malaria treatment to all age groups, including vulnerable newborn babies," said Shreeram Aradhye, President, Development and Chief Medical Officer at Novartis. “We have been committed to the fight against malaria for more than two decades, and this successful trial represents another milestone towards ensuring that all people have access to an appropriate antimalarial therapy.” The CALINA study is led by Novartis, with the scientific and financial support of Medicines for Malaria Venture (MMV), and as part of the PAMAfrica consortium, which is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP2). It is the first evidence-based trial conducted to evaluate a new antimalarial dose and regimen for all infants weighing under 5 kg with acute uncomplicated malaria. If approved, Novartis and MMV aim to make the treatment available as soon as possible to the youngest infants, who currently lack access to evidence-based treatment options. The new formulation, known as Coartem <5 kg Baby, uses a new ratio and dose of artemether-lumefantrine to account for metabolic differences in babies under 5kg. Infants under 5 kg can be affected by placental malaria, leading to poor birth outcomes, or contract malaria from the bite of an infected mosquito. The prevalence of the disease in this age and weight group is poorly understood, and it is therefore often misdiagnosed. Current antimalarials have not been developed specifically for infants weighing under 5 kg. There is no approved treatment available for them, and they are treated with tablets meant for children above 5 kg adjusted by weight2. Yet, these tiny patients handle drugs differently due to the immaturity of their metabolizing organs, which can lead to overdose and toxicity. Coartem <5 kg Baby provides optimized dosing specifically tailored to the needs of these vulnerable patients. If approved, the treatment will close a significant treatment gap. “Infants below 5 kg make up a critical neglected group, and developing antimalarials specifically suited to their needs is essential to malaria control efforts,” said Wiweka Kaszubska, Executive Vice President, Head of Product Development, MMV. “The success of the CALINA trial brings us one step closer to ensuring that all patients have access to appropriate and effective treatments.” “The CALINA trial is an example of the type of Europe-Africa collaboration we need to close malaria treatment gaps for vulnerable groups, and EDCTP is proud to be part of this endeavor,” said Pauline Beattie, Operations Manager and Scientific Advisor, EDCTP Association. This year's theme for World Malaria Day – Health Equity, Gender, and Human Rights – serves as a stark reminder of our collective responsibility to protect every child from malaria. It underscores the need to ensure that the youngest and most vulnerable among us also have access to the right treatment. About the CALINA studyPharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria (CALINA) is an open-label, single-arm, multicenter phase II/III study in young infants < 5 kg with uncomplicated Plasmodium falciparum malaria, which evaluated the PK, safety, tolerability and efficacy of a new dose regimen (5mg:60mg). The study consists of a core segment (treatment and follow-up for 43 days) and long-term follow-up at 12 months of age to assess neurodevelopmental status. The trial was conducted in Burkina Faso, DRC, Kenya, Mali, Nigeria, and Zambia. The primary PK endpoint of the study was met for patients > 28 days of age. For neonates <= 28 days of age, although the sample size was too small for a conclusive statistical evaluation, the required value of the PK endpoint was also within the calculated interval. The key secondary endpoint of lumefantrine C168 concentration was also met for cohort 1 and within range for cohort 2. This indicates that the new dose regimen/formulation delivers exposures to artemether and lumefantrine proven to be safe and effective in paediatric patients of higher body weight. More information about the trial can be found here. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. 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. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. About MMVMMV is a leading product development partnership (PDP) in the field of antimalarial drug development and delivery. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and facilitating delivery of new, effective and affordable antimalarial drugs. Since its foundation in 1999, MMV and partners have built the largest portfolio of antimalarial R&D and access projects ever assembled, have brought forward 15 medicines that are treating patients. An estimated 15.4 million deaths have been averted by these MMV co-developed medicines. MMV’s vision is a world in which innovative medicines will cure and protect the vulnerable and under-served populations at risk of malaria and help to ultimately eradicate this terrible disease. References World malaria report 2023 (who.int)WHO guidelines for malaria - 16 October 2023 (magicapp.org) # # # Novartis Media RelationsE-mail: media.relations@novartis.com Central North America Richard Jarvis+41 79 584 2326Michael Meo+1 862 274 5414Anja von Treskow+41 79 392 9697Marlena Abdinoor+1 617 335 9525Anna Schäfers+41 79 801 7267 Switzerland Satoshi Sugimoto+41 79 619 2035 Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central North America Isabella Zinck+41 61 324 7188Sloan Simpson+1 862 345 4440Nicole Zinsli-Somm+41 61 324 3809Jonathan Graham+1 201 602 9921Imke Kappes+41 61 324 8269Parag Mahanti+1 973 876 4912