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Target product profiles
The discovery and development of new medicines is a long term project. It is therefore important that at the outset there is clear agreement about what success looks like – a definition of the gold standard which may be in place in ten years time. This is the target ‘product profile’. In malaria we have the complication that a new medicine will consist of several active ingredients, and so in addition to a target product profile, there is also a need for a target ‘candidate’ profile, for each of the individual medicines.
In this document we explore the requirements for a candidate that makes up part of a ‘single exposure, radical cure’ for malaria. In parallel, the types of medicines that will be needed in the case that artemisinin resistant malaria becomes widespread are discussed. Finally new medicines for the prevention of infection in certain target vulnerable populations are explored. In all cases, new medicines must add a significant benefit compared with the current gold standard. They must be active against all known resistant strains, and as much as possible about potential resistance should be known. Significant benefit could be seen in terms of dose in man, speed of onset, overall reduction in parasitaemia and lack of an adverse event profile clinically.
Download the complete target product profile document [PDF: 84Kb, 17 pages]
View the target product profile document by section
- Introduction [PDF: 20Kb, 2 pages]
- Why do we need target product profiles (TPPs)? [PDF: 25Kb, 1 page]
- Combination medicines and the profile of individual medicines [PDF: 40Kb, 3 pages]
- Key characteristics of a clinical candidate [PDF: 27Kb, 3 pages]
- TPP 1: Single Exposure Radical Cure for the treatment of acute uncomplicated malaria in children and adults [PDF: 23Kb, 2 pages]
- TPP 2: Non-artemisinin-based combination therapy (NACT) for treatment of acute uncomplicated malaria in children and adults [PDF: 24Kb, 2 pages]
- TPP 3: Treatment of complicated/severe/cerebral malaria caused by Plasmodium falciparum in adults and children who are unable to take drugs orally [PDF: 22Kb, 2 pages]
- TPP 4: Target Candidate Profile for a single agent for the radical cure of malaria caused by Plasmodium vivax and P. ovale [PDF: 22Kb, 2 pages]
- TPP 5: Target Candidate Profile for a single agent to block the transmission of Plasmodium [PDF: 21Kb, 2 pages]
- TPP 6: Intermittent preventative treatment of malaria in pregnant women (IPTp) [PDF: 17Kb, 1 page]
- TPP 7: Chemoprophylaxis of malaria [PDF: 19Kb, 1 page]
This document was written by Timothy Wells, based on the 2008 Target Product Profiles which were assembled by Winston Gutteridge and Brian Greenwood. It reflects the discussions we have had at ESAC over the last two years, and we would like to thank both the advisors on our ESAC and the MMV staff members who have participate in this discussion and elaboration of some of the concepts over the last six months, especially Simon Campbell, Kip Guy Alan Hudson, and Dennis Schmatz.
The profiles have been refined further as a result of discussions with the MalERA group chaired by Pedro Alonso and Chris Plowe in 2009, and the WHO Disease Reference Group for Malaria chaired by Pedro Alonso in 2010. We are also grateful for the advice received from the EMA, the FDA and WHO Prequalification over the last three years. The work on parasite reduction ratios was led by Andrew Humberstone and Jeremy Burrows, and will be submitted for publication in the near future. This reflects the inputs from discussion on the Target Product Profile of the Malaria Eradication research agenda, particularly the definition of single exposure, radical cure and prophylaxis (SERCaP). Thanks to the many readers and reviewers for their comments, and all suggestions for further development are welcome (wellst [at] mmv [dot] org).