What are the health needs and challenges?
Malaria is one of the world’s biggest killers and Africa’s leading cause of mortality for children under five: every 2 minutes, a child dies of malaria in Africa. There were an estimated 219 million cases of malaria in 2017, causing an estimated 439,000 deaths.
Partnership activities and how they address needs and challenges
The Novartis Malaria Initiative focuses on improving access to treatment, helping communities in malaria-endemic countries deliver better healthcare and investing in research and development into the next generation of antimalarials. Focused on treatment, access, and capacity building, the Initiative is tailored to best meet patient needs.
In 1999, Novartis launched Coartem®, the first fixed-dose artemisinin-based combination therapy (ACT) antimalarial, prequalified by the WHO for its efficacy, safety and quality (and on the WHO’s Model List of Essential Medicines).
In 2009, Novartis and Medicines for Malaria Venture (MMV) introduced Coartem® Dispersible, the first ACT formulation specifically developed to address the treatment needs of children with malaria. Although children are the most vulnerable to malaria, there was until then no quality treatment adapted for this patient group and health workers and parents had to crush bitter-tasting antimalarial tablets for children to swallow.
Coartem® Dispersible tablets dissolve quickly in small amounts of liquid, easing administration and helping ensure effective dosing for children. Coartem® Dispersible contains the same amounts of artemether and lumefantrine as Coartem® tablets (20mg/120mg) and delivers the same cure rates.
Since 2001, working with partners, Novartis has delivered more than 880 million treatments of Coartem®, including more than 370 million Coartem® Dispersible treatments, without profit to malaria-endemic countries, contributing to a significant reduction of the death toll from malaria.
However, resistance to treatment presents the biggest threat to the incredible progress that has been made in the fight against malaria in the past 20 years,meaning new medicines are needed. Novartis is working with MMV to help prevent, treat and block the spread of malaria by developing next generation antimalarials with new mechanisms of action.
In June 2016, Novartis announced the expansion of its partnership with MMV to develop KAF156. KAF156 belongs to a novel class of antimalarial compounds that act against both the blood and liver stages of the parasite’s lifecycle and in September 2016, Novartis published proof of concept study results in the New England Journal of Medicine showing that KAF156 demonstrated activity against both vivax and falciparum malaria, including artemisinin-resistant parasites. Novartis leads the development of this compound with scientific and financial support from MMV in collaboration with the Bill & Melinda Gates Foundation. KAF156 holds the potential to be the first new chemical class of compound for the treatment of acute malaria in 20 years. The combination is currently in phase 2b clinical trials across 17 centers in nine countries in Africa and Asia.
KAE609 is another novel antimalarial compound developed by Novartis. It was discovered through a joint research program with the Novartis Institute for Tropical Diseases, Novartis Natural Products Research Group, the Genomics Institute of the Novartis Research Foundation, and the Swiss Tropical and Public Health Institute. Research was supported by the Wellcome Trust, the Singapore Economic Development Board, and Medicines for Malaria Venture (MMV). KAE609 belongs to the spiroindolone class and has a novel mechanism of action (PfATP4 inhibitor) that has demonstrated rapid clearance of parasites pre-clinically and in patients. Novartis is leading the development of KAE609 in collaboration with MMV and with financial support from the Wellcome Trust.
In an effort to tackle stock-outs of antimalarials in malaria-endemic countries, Novartis launched an innovative technology based healthcare program called SMS for Life 2.0 in Nigeria and Zambia. The enhanced program uses smartphones and tablet computers to enable local healthcare workers to track stock levels of antimalarials, other medicines and vaccines, and send notifications to district medical officers when stock levels are low. The program also allows to monitor disease surveillance and to train healthcare workers using on-demand eLearning modules.
Since the start, the Novartis Malaria Initiative has worked with its Chinese suppliers of artemether and lumefantrine to help them to improve manufacturing processes and productivity, raise product quality and achieve international GMP standards. Assistance provided has included training in quality assurance, quality control, laboratory analysis, regulatory requirements and cost management.
Malaria elimination requires action on several interconnected fronts – quality, affordability and accessibility of treatments are crucial, as well as effective case management, ensuring patient adherence and staying one step ahead of the parasite.. Innovative financing mechanisms are also critical in this sense as well as data and analytical tools enabling countries to track malaria’s spread more closely. But most importantly, it requires joint action and partnerships.