CONTACT: Joelle Dountio Ofimboudem, TAG: firstname.lastname@example.org; Kenly Sikwese, Afrocab:email@example.com
September 21, 2022 – As the global Long-Acting Technologies Community Advisory Board (LAT CAB) representing vast civil society networks, and people living with and affected by malaria, HIV, tuberculosis, and the hepatitis C virus (HCV) across the world, we welcome the efforts leading to the development of an investigational long-acting injectable (LAI) formulation of ivermectin to fight malaria transmission, mdc-STM currently in preclinical stage, and developed by MedinCell. We equally welcome the non-exclusive license agreement between the Medicines Patent Pool (MPP) and MedinCell announced on September 13, 2022 on mdc-STM allowing MPP to support the identification of suitable partners to develop and commercialize mdc-STM in low- and middle-income countries. This LAI formulation of ivermectin is based on MedinCell’s BEPO technology and offers a three-month action duration.
While this LAI is not able to prevent malaria, mosquitoes feeding on persons having received the LAI will either be killed or made less capable of transmitting malaria parasites, hence, decreasing the mosquito population and thus benefiting the whole community by lowering the risk of malaria transmission.
Based on the license, MPP would grant royalty-free sublicences for sales in public markets in low- and middle-income countries, while ‘reasonable royalties’ would be charged for sales in private markets. The license also includes a commitment by MedinCell to technology transfer in the form of know-how to the MPP for use by sublicensees for generic manufacturing.
Based on World Health Organization statistics, there were 241 million malaria cases resulting in 627,000 deaths worldwide in 2020, with sub-Saharan Africa bearing the greatest burden – 95% and 96% respectively– with over 80% of these deaths occurring in children under 5 years of age. The continuing high prevalence of malaria and the preventable deaths in our communities over 50 years after its eradication in high-income countries is unacceptable. Hence, the need for such a malaria LAI to reach the millions of people at higher risk of malaria as quickly as possible.
While still at a pre-clinical stage, if mdc-STM is eventually proven to be safe, efficacious, and acceptable it could help accelerate the achievement of the malaria eradication goals set out in the WHO Global Technical Strategy for Malaria 2016-2030.
While we are pleased that the license is non-exclusive and manufacturing of the LAI can be carried out in any country worldwide, charging royalties in private markets in low- and middle income countries where malaria is endemic will unfortunately not advance malaria eradication goals as the vast majority of treatment costs are paid for out-of-pocket by patients. The LAT CAB therefore strongly urges that the license be royalties-free across the board, including in private markets in low- and middle-income countries. We recommend that the MPP use this list of low- and middle-income countries from the Shionogi, Global Antibiotic Research and Development Partnership (GARDP) and Clinton Health Access Initiative (CHAI) license on the antibiotic cefiderocol as a guideline for future licenses with pharmaceutical companies.
As this malaria LAI is being developed the LAT CAB calls on national and international regulatory authorities to monitor this ongoing research, and prepare health systems to absorb long-acting therapies.
Also, given that this research is publicly funded, the LAT CAB calls on MedinCell, Unitaid and MPP to:
- Ensure community engagement with civil society organizations working on malaria to ensure their voices and concerns are taken into account in the product development process;
- Ensure that, when promoting manufacturing capacity for this LAI therapy, the lessons learned from the COVID-19 pandemic are taken into account and that manufacturing capacity is effectively established in low- and middle-income countries.