From: The global pipeline of new medicines for the control and elimination of malaria
 | Artemether lumefantrine | Artesunate amodiaquine | Dihydroartemisinin piperaquine | Pyronaridine artesunate | Artesunate mefloquine | Artemisinin naphthoquine |
---|---|---|---|---|---|---|
Partner | Novartis, MMV | Sanofi, DNDi, (MMV) | sigma-tau, Pfizer, MMV | Shin Poong, MMV | Farmanguinhos/DNDi, Cipla; Mepha | AMMS, Kunming Pharma Corp |
Trade name | Coartem®; Coartem-® Dispersible | Coarsucam®; ASAQ-Winthrop® | Eurartesim® | Pyramax® | ASMQ | ARCO® |
Approval Date | 1Q'01/1Q'09 Swiss-Medic | 2Q'07 Morrocco Prequalified 4Q’08 | 4Q'11 EMA | 1Q'12 EMA and Prequalification | 2Q'08 Brazil Prequalification anticipated | 2005 China |
Stringent Approval | Yes: CH, US-FDA, WHO Prequalified | No: Morocco, WHO Prequalified | EMA Submitted; approved by the CHMP in Jun 2011, and EU in Oct 2011 | EMA Submitted. Approved by the Korean FDA in Aug 2011; approved by EMA in Feb 2012 | Farmanguinhos/DNDi No: Brazil, WHO Prequalification submitted; Mepha product approved in West Africa and Portugal | No: Sino-FDA for the moment |
Formulation | Tablet (adult), dispersible flavoured tablets (child) | Dispersible tablets for all ages | Tablet (adult, child), dispersible formulation for children (submission in 2014) | Tablet (adult), sachet with granules (child), (submission in 2014) | Tablet (adult, child) | Tablet (adult, child) |
Key Strengths | 350 million treatments to date. Paediatric formulation is dispersible and flavoured | First line therapy in francophone Africa. Three-year shelf life. Once per day, three days. Paediatric dose. | Once per day, three-day treatment course. Long terminal half-life of piperaquine. Strong post-treatment protection of 42 days | Once per day, three-day treatment. Granulated paediatric formulation with taste-masking. Best preclinical and clinical data against Plasmodium vivax. | Once a day, three-day treatment. Strong post-treatment prophylaxis. Active against chloroquine resistant P. vivax. | Single dose treatment, may be split over two days. |
Key Weakness | Twice per day | Amodiaquine resistance in some countries. GI adverse events | Previous concerns on stability, but data now support two years under Zone IVb conditions | Tablets can only be given to patients >20 kg. Limited repeat dose data. Currently only recommended for a single treatment | Psychiatric and GI adverse events. Mefloquine-resistant strains exist. Concern over use where mefloquine prophylaxis is recommended. Currently relatively expensive ($2.50) | No GCP clinical studies or safety data. Insufficient information on ARCO for children. No stringent regulatory approval |
Market size & strength 2010 | First line treatment in 35 countries. 82 million treatments (37 million Coartem-® Dispersible) per year. Estimated 21 million are generic artemether/lumefantrine. | 45 million (fixed-dose combinations). First line treatment in 17 countries (West Africa) | Two million treatments per year. Registered in 30% of African countries. First line therapy in Cambodia, on treatment guidelines in six countries | Not launched yet. Should be medicine of choice in Asia/Pacific dual-infection areas. | Still relatively small (200,000 treatments). An Indian approval would significantly change this. | Registered in more than 10 countries. Treats one million patients per year. |
Stability | 24 months | 36 months | 24 months | 24+ months | 36 months (Brazil) | Unknown |
Public sector pricing (USD) | $0.74 weighted average (from $0.37-$1.41 depending on weight) | $0.60 weighted average (from $0.30-$1.50 depending on weight) | Estimated $0.90-$1.10 weighted average (from $0.50-$1.50 depending on weight). Final price may be higher due to DHA prices | $1.10 weighted average (from $0.34-$2.12, lowest to highest weight band). Final price may be higher due to artesunate prices | Currently at $2.50 per adult. New mefloquine synthesis should make the price similar to other ACT | Not sold in the public sector. |