MMV’s Sixth Annual Stakeholders’ Meeting took place from 6-8 May 2006 in Livingstone, Zambia
During the Stakeholders’ meeting, MMV was extremely pleased to present its Project of the Year award to Shin Poong Pharm. Co., Ltd (Shin Poong) of Seoul South Korea for their work on the antimalarial fixed-dose combination drug, Pyronaridine-Artesunate.
This project was chosen from 20 projects in MMV’s portfolio for its outstanding progress through clinical development. This next-generation artemisinin-combination therapy (ACT) could become a major weapon against drug-resistant malaria. Since the inception of the award five years ago, this is the first time the award has been given to a project in clinical development rather than in the earlier phases of drug discovery.
Pyronaridine-Artesunate is a new fixed-dosed combination based on artemisinin combination therapy (ACT), currently the most effective type of antimalarial treatment. It has completed its large Phase II studies with 470 patients in Asia and Africa. While data are being processed for final analysis and reporting, planning has started for a multi-center large Phase III trial. Both adult and children will be enrolled for the efficacy trials set to start in mid-summer. These studies will be followed by another study in younger children which will assess efficacy of a new pediatric formulation. If the Phase III trials confirm the phase II results, regulatory filing to the European Medicines Agency (EMEA) and the Korean Food and Drug Agency is expected by the end of 2007 with the new antimalarial ready to market in 2008.
MMV’s Expert Scientific Advisory Committee selected the Pyronaridine-Artesunate project for its achievements not only in successful progress from Phase I to Phase II clinical studies and excellent presentation of the data, but also in the quality of the management of the project.