Dihydroartemisinin: More Life-boat than Death-ride
Dennis Schmatz, Medicines for Malaria Venture
29 July 2010
Sir,
I write in response to the commentary article in your journal entitled “The pharmaceutical death-ride of dihydroartemisinin” (Malaria Journal 2010, 9:212 doi:10.1186/1475-2875-9-212), written by Dr Frans Herwig Jansen, President of Dafra Pharma International, Belgium. As President and Chief Executive Officer of MMV, I would like to clarify a few points:
Medicines for Malaria Venture (MMV), in partnership with sigma-tau Industrie Farmaceutiche Riunite, has indeed developed a stable fixed-dose artemisinin-based combination therapy (ACT) of dihydroartemisinin and piperaquine (DHA-PQP). Stability data collected according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for Zones III/IV has shown that the combination is stable for 24 months up to temperatures of 30°C, relative humidity up to 65%. The complete dossier, including all chemistry, manufacturing and control (CMC) data on stability, degradation, impurities and their full characterization and toxicological qualification, was submitted for regulatory approval to the European Medicines Agency (EMA) in July 2009.
The EMA is Europe’s primary agency responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products. The Agency plays a role in stimulating innovation and research in the pharmaceutical sector and gives scientific advice and protocol assistance to companies for the development of new medicinal products. As far as MMV is concerned, the decision on DHA-PQP’s stability is in the hands of experts who routinely review the stability of all drugs for the European market.
DHA-PQP is one of several clinical development projects in MMV’s antimalarial portfolio, which contains over 50 projects. Piperaquine is a bisquinoline with a relatively long half-life compared to other partner drugs within current ACTs. As a result, and proven by clinical trials, DHA-PQP is effective both in treating clinical malaria and in providing longer protection from re-infection than other ACTs.
DHA-PQP is not an ‘inadequate drug’. We believe it is a life-saving medicine that will be a much-needed addition to the malaria arsenal. It is one of the most widely investigated ACTs available, and is now being evaluated for regulatory approval by a stringent international authority. The submission of DHA-PQP by sigma-tau to EMA is in line with MMV’s overarching commitment to ensuring that all products from its antimalarial drug pipeline are developed and manufactured to the highest international standards of good practice and quality (including their stability) before being made available to malaria-endemic countries. Not only are we guided by this commitment but we encourage all our drug development partners to work towards these high standards.
Sincerely, Dennis Schmatz
Competing interests
Dennis Schmatz is the President and Chief Executive Officer of Medicines for Malaria Venture – a nonprofit foundation created to discover, develop and deliver new, affordable antimalarial drugs through effective public-private partnerships.
Dihydroartemisinin: More Life-boat than Death-ride
29 July 2010
Sir,
I write in response to the commentary article in your journal entitled “The pharmaceutical death-ride of dihydroartemisinin” (Malaria Journal 2010, 9:212 doi:10.1186/1475-2875-9-212), written by Dr Frans Herwig Jansen, President of Dafra Pharma International, Belgium. As President and Chief Executive Officer of MMV, I would like to clarify a few points:
Medicines for Malaria Venture (MMV), in partnership with sigma-tau Industrie Farmaceutiche Riunite, has indeed developed a stable fixed-dose artemisinin-based combination therapy (ACT) of dihydroartemisinin and piperaquine (DHA-PQP). Stability data collected according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for Zones III/IV has shown that the combination is stable for 24 months up to temperatures of 30°C, relative humidity up to 65%. The complete dossier, including all chemistry, manufacturing and control (CMC) data on stability, degradation, impurities and their full characterization and toxicological qualification, was submitted for regulatory approval to the European Medicines Agency (EMA) in July 2009.
The EMA is Europe’s primary agency responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products. The Agency plays a role in stimulating innovation and research in the pharmaceutical sector and gives scientific advice and protocol assistance to companies for the development of new medicinal products. As far as MMV is concerned, the decision on DHA-PQP’s stability is in the hands of experts who routinely review the stability of all drugs for the European market.
DHA-PQP is one of several clinical development projects in MMV’s antimalarial portfolio, which contains over 50 projects. Piperaquine is a bisquinoline with a relatively long half-life compared to other partner drugs within current ACTs. As a result, and proven by clinical trials, DHA-PQP is effective both in treating clinical malaria and in providing longer protection from re-infection than other ACTs.
DHA-PQP is not an ‘inadequate drug’. We believe it is a life-saving medicine that will be a much-needed addition to the malaria arsenal. It is one of the most widely investigated ACTs available, and is now being evaluated for regulatory approval by a stringent international authority. The submission of DHA-PQP by sigma-tau to EMA is in line with MMV’s overarching commitment to ensuring that all products from its antimalarial drug pipeline are developed and manufactured to the highest international standards of good practice and quality (including their stability) before being made available to malaria-endemic countries. Not only are we guided by this commitment but we encourage all our drug development partners to work towards these high standards.
Sincerely,
Dennis Schmatz
Competing interests
Dennis Schmatz is the President and Chief Executive Officer of Medicines for Malaria Venture – a nonprofit foundation created to discover, develop and deliver new, affordable antimalarial drugs through effective public-private partnerships.