active
ACTIVE SINCE: 2001

Novartis Malaria Program

The Novartis Malaria Program continues to deliver the antimalarial Coartem® to patients and communities in need and is also committed to researching and developing next-generation antimalarials, improving access to treatment, and helping to build clinical trial capability and capacity in Africa.
SGDS CONTRIBUTING TO:
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MEMBER COMPANIES:
Academia or research institute 2
Private Foundation or Development Organization 2
Government 2
Professional and Trade Associations 1
Product Development Partnerships 1
Objectives
  • Ensure access to quality-assured artemisinin-based combination therapies (ACTs) for adults and children, including vulnerable infants, in malaria-endemic countries
  • Collaborate with partners to research and develop the next generation of antimalarials
  • Work with external partners to support strengthening and expansion of research capacities in Africa  

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 minute, a child dies of malaria in Africa. There were an estimated 247 million cases of malaria in 2021, causing an estimated 619,000 deaths.

Partnership activities and how they address needs and challenges

In 1999, Novartis launched Coartem®, the first fixed-dose artemisinin-based combination therapy (ACT) antimalarial, prequalified by the World Health Organization (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.

We are now also developing a new optimized dose strength of our ACT to address the needs of infants weighing less than five kilograms. The clinical trial for this new treatment started in 2021 and is ongoing.

Since 2001, working with partners, Novartis has delivered more than 1 billion treatments of Coartem®, including more than 450 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 partners to develop next-generation antimalarials. We currently lead several malaria development programs featuring compounds that employ new mechanisms of action and activity against artemisinin-resistant strains of the disease.

KAF156 (ganaplacide) belongs to a novel class of antimalarial compounds that act against both the blood and liver stages of the parasite’s lifecycle. It demonstrated activity against both vivax and falciparum malaria, including artemisinin-resistant parasites. It is being developed as a combination with a new formulation of lumefantrine. In November 2022, Novartis and MMV announced the decision to progress the combination into Phase 3 development in 2023. The trial will be conducted in collaboration with the WANECAM 2 consortium, and will include partner clinical sites in Burkina Faso, Mali, Gabon and Niger as well as other sites in sub-Saharan Africa. Novartis leads the development of this compound with scientific and financial support from MMV in collaboration with the Bill & Melinda Gates Foundation.

KAE609 (cipargamin) is another compound with a novel mechanism of action, which displays extremely rapid parasite clearance in patients. It is being developed for the treatment of severe malaria with financial support from Wellcome.

In 2020, Novartis advanced another novel malaria therapy, INE963, a fast acting long-lasting antimalarial with an entirely new mechanism of action. INE963 is in early clinical trials. It is developed in collaboration with MMV and received the organization’s “Project of the Year” award in 2020.

The clinical trials for ganaplacide are conducted as part of the WANECAM2 consortium, while trials for cipargamin and our infant formulation are part of the PAMAfrica research consortium led by MMV. Both trials are funded by the European and Developing Countries Clinical Trials Partnership (EDCTP).

Renewed commitment to malaria elimination

In June 2022, at the Kigali Summit on Malaria and Neglected Tropical Diseases (NTDs), Novartis announced a five-year (2021-2025) financial commitment of USD 250 million to advance R&D of new treatments to combat malaria and NTDs.

The company will also continue with activities to support the development of an optimized formulation for neonates and infants under 5kg, for whom no treatment currently exists.

Quote
"The story of the Novartis child-friendly ACT is proving that partnerships are key, not only to develop new, high-quality medicines for malaria but also to deliver these to vulnerable populations."
Dr. David Reddy
CEO, Medicines for Malaria Venture
Results and milestones

Since 2001, working with partners, Novartis has delivered more than 1 billion treatments of Coartem®, including more than 450 million Coartem® Dispersible treatments, without profit to malaria-endemic countries, contributing to a significant reduction of the death toll from malaria

Geographic Reach
  • Africa
  • Americas
  • Eastern Mediterranean
  • South-East Asia
  • Western Pacific
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Disease Area
  • Infectious and Parasitic Disease
  • Women’s and Child Health
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Target Population
  • Children
  • Youth
  • Women
  • Men
  • Elderly
  • Marginalized/indigenous people
Partner organizations
Academia or research institute

PAMAfrica research consortium

WANECAM2

Private Foundation or Development Organization

Wellcome Trust

Bill and Melinda Gates Foundation

Government

National Malaria Control Programs (NMCPs)

Ministries of Health in malaria-endemic countries

Professional and Trade Associations

European and Developing Countries Clinical Trials Partnership Programme (EDCTP)

Product Development Partnerships

Medicines for Malaria Venture (MMV)