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The global pipeline of new medicines for the control and elimination of malaria.

Anthony MP, Burrows JN, Duparc S, Moehrle JJ, Wells TN - Malar. J. (2012)

Bottom Line: Simpler regimens, such as a single-dose cure are needed, compared with the current three-day treatment.In addition, new medicines that prevent transmission and also relapse are needed, but with better safety profiles than current medicines.The nascent pipeline of new medicines is significantly stronger than five years ago.

View Article: PubMed Central - HTML - PubMed

Affiliation: Medicines for Malaria Venture (MMV), 20 rte de Pré-Bois 1215, Geneva, Switzerland.

ABSTRACT
Over the past decade, there has been a transformation in the portfolio of medicines to combat malaria. New fixed-dose artemisinin combination therapy is available, with four different types having received approval from Stringent Regulatory Authorities or the World Health Organization (WHO). However, there is still scope for improvement. The Malaria Eradication Research agenda identified several gaps in the current portfolio. Simpler regimens, such as a single-dose cure are needed, compared with the current three-day treatment. In addition, new medicines that prevent transmission and also relapse are needed, but with better safety profiles than current medicines. There is also a big opportunity for new medicines to prevent reinfection and to provide chemoprotection. This study reviews the global portfolio of new medicines in development against malaria, as of the summer of 2012. Cell-based phenotypic screening, and 'fast followers' of clinically validated classes, mean that there are now many new classes of molecules starting in clinical development, especially for the blood stages of malaria. There remain significant gaps for medicines blocking transmission, preventing relapse, and long-duration molecules for chemoprotection. The nascent pipeline of new medicines is significantly stronger than five years ago. However, there are still risks ahead in clinical development and sustainable funding of clinical studies is vital if this early promise is going to be delivered.

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Sales (USD) of fixed dose artemisinin combination therapy 2006 2010. These data are compiled from estimates supplied by the WHO-prequalified manufacturers and from data provided by AMFm and include only WHO-prequalified or Global Fund-approved generic versions of the medicines. Sales of DHA/piperaquine have been around two million per year, and naphthoquine artemisinin around one million per year. Mefloquine-artesunate numbers are significantly lower. These numbers compare well with the lower range of the estimates predicted by the Clinton Foundation[42]. The total number of malaria patients was estimated by WHO to have fallen to 225 million in 2009[7].
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Figure 2: Sales (USD) of fixed dose artemisinin combination therapy 2006 2010. These data are compiled from estimates supplied by the WHO-prequalified manufacturers and from data provided by AMFm and include only WHO-prequalified or Global Fund-approved generic versions of the medicines. Sales of DHA/piperaquine have been around two million per year, and naphthoquine artemisinin around one million per year. Mefloquine-artesunate numbers are significantly lower. These numbers compare well with the lower range of the estimates predicted by the Clinton Foundation[42]. The total number of malaria patients was estimated by WHO to have fallen to 225 million in 2009[7].

Mentions: Today, first-line medicines against malaria are fixed-dose artemisinin combination therapy (ACT). These medicines are assumed to be active against the blood stages of all of the major forms of Plasmodium which infect humans: falciparum, vivax, malariae, ovale and knowlesi. Fixed-dose combination therapy has the advantage over co-blistered presentations in that it eliminates the potential for monotherapy[4], which is to be avoided since it risks the emergence and selection of resistant parasites[5]. Six of these have been reviewed by regulatory authorities throughout the world (see Table1, Figures1 and2). Artemether-lumefantrine (Coartem® and Coartem® Dispersible from Novartis), artesunate-amodiaquine (Coarsucam™/Artesunate Amodiaquine-Winthrop® from Sanofi), pyronaridine-artesunate (Pyramax® from Shin Poong Pharmaceuticals) and mefloquine-artesunate from Cipla/DNDi– have been prequalified by WHO[6]. Their launch has had a dramatic impact on the number of courses of treatment available to malaria patients. There has been rapid growth from 62.3 million treatments in 2006 to 159.7 million in 2010 (see Figure2) although, still, not all medicines reach the patients who need them[7]. Considerable progress has been made on price, with the costs of an adult course of treatment falling to $1.00–$1.40. For infants the price can be as low as $0.30[8], although in 2011 prices rose due to perceived artemisinin shortages[9].


The global pipeline of new medicines for the control and elimination of malaria.

Anthony MP, Burrows JN, Duparc S, Moehrle JJ, Wells TN - Malar. J. (2012)

Sales (USD) of fixed dose artemisinin combination therapy 2006 2010. These data are compiled from estimates supplied by the WHO-prequalified manufacturers and from data provided by AMFm and include only WHO-prequalified or Global Fund-approved generic versions of the medicines. Sales of DHA/piperaquine have been around two million per year, and naphthoquine artemisinin around one million per year. Mefloquine-artesunate numbers are significantly lower. These numbers compare well with the lower range of the estimates predicted by the Clinton Foundation[42]. The total number of malaria patients was estimated by WHO to have fallen to 225 million in 2009[7].
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3472257&req=5

Figure 2: Sales (USD) of fixed dose artemisinin combination therapy 2006 2010. These data are compiled from estimates supplied by the WHO-prequalified manufacturers and from data provided by AMFm and include only WHO-prequalified or Global Fund-approved generic versions of the medicines. Sales of DHA/piperaquine have been around two million per year, and naphthoquine artemisinin around one million per year. Mefloquine-artesunate numbers are significantly lower. These numbers compare well with the lower range of the estimates predicted by the Clinton Foundation[42]. The total number of malaria patients was estimated by WHO to have fallen to 225 million in 2009[7].
Mentions: Today, first-line medicines against malaria are fixed-dose artemisinin combination therapy (ACT). These medicines are assumed to be active against the blood stages of all of the major forms of Plasmodium which infect humans: falciparum, vivax, malariae, ovale and knowlesi. Fixed-dose combination therapy has the advantage over co-blistered presentations in that it eliminates the potential for monotherapy[4], which is to be avoided since it risks the emergence and selection of resistant parasites[5]. Six of these have been reviewed by regulatory authorities throughout the world (see Table1, Figures1 and2). Artemether-lumefantrine (Coartem® and Coartem® Dispersible from Novartis), artesunate-amodiaquine (Coarsucam™/Artesunate Amodiaquine-Winthrop® from Sanofi), pyronaridine-artesunate (Pyramax® from Shin Poong Pharmaceuticals) and mefloquine-artesunate from Cipla/DNDi– have been prequalified by WHO[6]. Their launch has had a dramatic impact on the number of courses of treatment available to malaria patients. There has been rapid growth from 62.3 million treatments in 2006 to 159.7 million in 2010 (see Figure2) although, still, not all medicines reach the patients who need them[7]. Considerable progress has been made on price, with the costs of an adult course of treatment falling to $1.00–$1.40. For infants the price can be as low as $0.30[8], although in 2011 prices rose due to perceived artemisinin shortages[9].

Bottom Line: Simpler regimens, such as a single-dose cure are needed, compared with the current three-day treatment.In addition, new medicines that prevent transmission and also relapse are needed, but with better safety profiles than current medicines.The nascent pipeline of new medicines is significantly stronger than five years ago.

View Article: PubMed Central - HTML - PubMed

Affiliation: Medicines for Malaria Venture (MMV), 20 rte de Pré-Bois 1215, Geneva, Switzerland.

ABSTRACT
Over the past decade, there has been a transformation in the portfolio of medicines to combat malaria. New fixed-dose artemisinin combination therapy is available, with four different types having received approval from Stringent Regulatory Authorities or the World Health Organization (WHO). However, there is still scope for improvement. The Malaria Eradication Research agenda identified several gaps in the current portfolio. Simpler regimens, such as a single-dose cure are needed, compared with the current three-day treatment. In addition, new medicines that prevent transmission and also relapse are needed, but with better safety profiles than current medicines. There is also a big opportunity for new medicines to prevent reinfection and to provide chemoprotection. This study reviews the global portfolio of new medicines in development against malaria, as of the summer of 2012. Cell-based phenotypic screening, and 'fast followers' of clinically validated classes, mean that there are now many new classes of molecules starting in clinical development, especially for the blood stages of malaria. There remain significant gaps for medicines blocking transmission, preventing relapse, and long-duration molecules for chemoprotection. The nascent pipeline of new medicines is significantly stronger than five years ago. However, there are still risks ahead in clinical development and sustainable funding of clinical studies is vital if this early promise is going to be delivered.

Show MeSH
Related in: MedlinePlus