Published in:
Open Access 01-12-2013 | Case study
MMV in partnership: the Eurartesim® experience
Published in: Malaria Journal | Issue 1/2013
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Background
This case study describes how a public-private partnership between Medicinesfor Malaria Venture (MMV) and Sigma-Tau Industrie Farmaceutiche Riunite SpAachieved international regulatory approval for use of the fixed-doseartemisinin-based combination therapy dihydroartemisinin-piperaquine(Eurartesim®) for the treatment of malaria, enablingmore widespread access to the medicine in malaria-endemic countries.
Case description
The combination of dihydroartemisinin and piperaquine demonstrated success inclinical trials for the treatment of malaria in Asia and Africa in the2000s. However, as it had not been developed to international regulatorystandards it was out of the reach of the majority of patients indisease-endemic countries, particularly those reliant on public healthcaresystems supported by international donor funding. To overcome this, as of2004 MMV worked in partnership with Sigma-Tau, Holleykin, Oxford University,the Institute of Tropical Medicine Antwerp, and the National Institute ofMalaria Research India to develop the dihydroartemisinin-piperaquinecombination to international standards. In 2011, the European Commissiongranted full marketing authorization to Sigma-Tau for Eurartesim.
Discussion and evaluation
The partnership between MMV, Sigma-Tau, and numerous other academic andindustrial partners across the world, led to the successful development toEMA regulatory standards of a high-quality and highly efficaciousanti-malarial treatment that otherwise would not have been possible. Thedossier has also been submitted to the WHO for prequalification, and asafety statement to guide correct use of Eurartesim has been produced. InJuly 2012, the first delivery to a disease-endemic country was made toCambodia, where the medicine is being used to treat patients and helpcounter the emergence of artemisinin resistance in the area. A paediatricdispersible formulation of Eurartesim is being developed, with the objectiveto submit the dossier to the EMA by the end of 2014.
Conclusions
The development of Eurartesim to international regulatory standardsexemplifies the strengths of the product development partnership model inutilising the individual skills and expertise of partners with differingobjectives to achieve a common goal. Successful uptake of Eurartesim bypublic health systems in malaria-endemic countries poses new challenges,which may require additional partnerships as we move forward.