Novartis and Medicines for Malaria Venture (MMV) announced the launch of Coartem Dispersible, a new paediatric formulation of Coartem (artemether/lumefantrine 20 mg/120 mg), for the treatment of uncomplicated malaria in infants and children.
Coartem Dispersible contains the same amounts of artemether and lumefantrine as Coartem, the leading artemisinin-based combination therapy (ACT) in Africa, and is the first dispersible fixed-dose ACT developed especially for children.
Each year there are more than one million malaria-related deaths around the world. Nine out of ten malaria deaths occur in sub Saharan Africa, and the vast majority of malaria-related deaths occur in children. In Africa alone, a child dies every 30 seconds from malaria.
"This new Coartem Dispersible tablet can help improve treatment and compliance saving many of the more than 700,000 children under five who die each year from malaria," said Dr Daniel Vasella, chairman and CEO of Novartis. "I am pleased that we can provide a clearly better formulation to help ensure children with malaria receive and can take an effective therapy."
Until now, many parents crushed bitter-tasting anti-malarial tablets for their children to swallow. The new sweet-tasting Coartem Dispersible tablets disperse quickly in small amounts of water, easing administration and ensuring effective dosing for children.
"The launch of Coartem Dispersible is an important milestone in the fight against malaria and marks the culmination of several years of successful collaboration with Novartis," said Dr Chris Hentschel, president and CEO of Medicines for Malaria Venture. "As malaria is essentially a paediatric disease, we are hopeful that this child-friendly formulation will contribute to a reduction in child mortality in Africa, and give children back their future."
A phase-III study recently published in The Lancet showed that Coartem Dispersible provides a high cure rate of 97.8 per cent, which is comparable to that of Coartem (98.5 per cent). Investigators also reported that it had a good safety profile.
As part of its ongoing commitment to patients and health workers, Novartis and MMV also provide malaria case management educational programs, which include hands-on training for local healthcare workers, customized training manuals, and user-friendly packaging to ensure that Coartem Dispersible is properly used and to improve patient compliance. Like Coartem, Coartem Dispersible will be provided to the public sector without profit to benefit those people most in need in the developing world. In addition to Swissmedic, Coartem Dispersible is approved by several regulatory authorities in Africa. These countries include Benin, Burkina Faso, Democratic Republic of Congo, Gabon, Ghana, Guinea, Ivory Coast, Kenya, Madagascar, Mauritania, Niger, Nigeria, Senegal, Togo, and Zambia.
In a unique collaboration with international organizations, Novartis has provided more than 215 million Coartem treatment courses to the public sector in Africa without profit since 2001. These treatments have helped to save approximately 550,000 lives.
Artemisinin is a compound derived from the sweet wormwood plant and has been used for centuries in traditional Chinese medicine to treat fever. An ACT is a combination of two or more drugs (one of which is an artemisinin derivative) that have different modes of action. Studies have shown that using two or more drugs in combination has the potential to delay the development of resistance. ACTs in particular have been found to be highly effective in treating malaria and their potential to delay resistance in areas of intense transmission is under investigation.