Project Leader: Dr Isabelle Borghini, MMV
Partners: Shin Poong Pharmaceuticals, South Korea and University of Iowa, IA, USA
Pyramax®, the fixed-dose combination of pyronaridine and artesunate has been developed as a cure for uncomplicated P. falciparum malaria and for the blood stage of P. vivax malaria. The tablet formulation was granted a positive scientific opinion from the European Medicines Agency (EMA) under Article 58 in February 2012.
In addition to the tablet formulation, a child-friendly granule formulation has been developed. This formulation, specifically designed for use in paediatric patients from 6 months (5 kg body weight) with acute uncomplicated malaria is presented in sachet form to be administered once a day for 3 days.
Shin Poong has manufactured the Pyramax® Granules for clinical studies and future commercial use at their facilities in South Korea. The facilities were inspected by the EMA in January 2011 and confirmed to be compliant with standards equivalent to European Good Manufacturing Practices.
A randomised, controlled, multicentre Phase III trial was performed to assess the efficacy, tolerability and safety of the Pyramax Paediatric granule formulation compared to artemether-lumefantrine treatment (crushed tablet) in over 500 infants ≤ 12 years of age with P. falciparum malaria. Conducted in disease-endemic countries in both sub-Saharan Africa (Mali, Ivory Coast, Kenya, Democratic Republic of Congo, Gabon, Burkina-Faso) and Asia (The Philippines), the trial achieved its primary endpoints, demonstrating Pyramax’s high level of efficacy in this patient population. The drug was also well tolerated and the granule formulation was shown to be easy to administer.
Additional data is being gathered in patients under 20 kg for both single and repeated treatment with Pyramax as part of the ongoing WANECAM longitudinal study of artemisinin combination therapies (ACTs), led by Prof. Djimdé and his collaborators in Mali, Burkina faso and Guinea.
Work is ongoing to submit the dossier for the Pyramax Paediatric formulation to EMA for review, through the Article 58 Opinion route.