The Swiss-based nonprofit organization Medicines for Malaria Venture (MMV) received a $115 million grant from the Bill & Melinda Gates Foundation to support the continued development of new, affordable antimalarial drugs for people in endemic regions. The award is MMV’s fifth and largest from the foundation.
MMV has built a portfolio of over 50 new antimalaria projects, of which 10 are in clinical development, explains Timothy Wells, M.D., the venture’s CSO. “Over the last few months with our partners, we have launched a high-quality antimalarial designed especially for children (Coartem® Dispersible), submitted another antimalarial to the EMEA for regulatory approval (Euroartesim™), and are in the process of collating the regulatory dosier for a third antimalarial (Pyramax®).”
Coartem Dispersible was launched by MMV and partner, Novartis, in January. The drug is a pediatric formulation of Coartem® (artemether/lumefantrine 20 mg/120 mg) for the treatment of uncomplicated malaria in infants and children. Coartem Dispersible has been approved in Switzerland and in 14 countries in Africa. It will be provided at cost to the public sector in malaria-endemic countries.
Eurartesim was developed in collaboration with sigma-tau Industrie Farmaceutiche Riunite in Rome. The drug was submitted to the EMEA for regulatory approval in July. Eurartesim is being developed for administration using a three-day dosing regimen. MMV claims that the drug has been found to be highly effective against P. Falciparum malaria in both adults and children.
Currently in late-stage clinical development, Pyramax is a fixed-dose combination of artesunate with 4-aminoquinoline pyronaridine for the treatment of uncomplicated P. falciparum and P. vivax. In 2008, MMV completed four pivotal Phase III trials with Pyramax, involving a total of 3,533 patients in 18 countries. In all cases the trials achieved their primary endpoints of noninferiority compared with current standard of care at 28 days.
Pyramax is being developed in collaboration with Shin Poong Pharmaceuticals, which MMV says has been working on process improvements to bring down the cost of therapy toward $1 for a three-day treatment course. Shin Poong has also opened a new $40 million GMP production facility with the capacity to provide hundreds of millions of treatments once the product is launched.