Methylene blue poised to move into the clinic
pharmafile | February 24, 2010 | News story | Manufacturing and Production, Research and Development | Novasep, ProveBlue, Provepharm, malaria
A new purer form of the reagent methylene blue could take the compound out of the testing laboratory and into the clinic as a treatment for a wide range of indications including malaria and urinary tract infections.
The new version, called ProveBlue (methylthioninium chloride) and developed by Provepharm in collaboration with French manufacturing process specialist Novasep, has been submitted for approval by the European Medicines Agency (EMA).
At the same time, Novasep’s manufacturing process for the ProveBlue active ingredient has been given a green light by the EMA, after a successful inspection by the French medicines regulatory authority (AFSSAPS) in October 2009.
Although originally developed in the 19th century as a malaria treatment, it fell out of favour because of side effects and since then has been tested sporadically in conditions ranging from cancer to Alzheimer’s disease.
It is also widely used in diagnostics and pharmaceutical manufacturing, for example to test the integrity of packaging materials, and has some therapeutic applications such as the treatment of methemoglobinaemia, a disorder than can result from an inherited genetic defect or as a side effect of certain pharmaceuticals.
Provepharm believes that use of its material could allow pharmaceutical companies to update licenses for methylene blue-based products and resume commercialisation, as well as pursue new indications.
The key hurdle towards its broader use as a therapeutic has been the difficulties associated with getting a highly-pure solution of methylene blue without the impurities thought to be responsible for many of its adverse reactions.
At the moment, methylene blue “generally contains high levels of heavy metals that are toxic in patients”, according to Provepharm, adding that Novasep’s processing expertise helped reduce the level of impurities in the API 100-fold.
“Solving the tough industrialisation process with the help of Novasep has enabled Provepharm to win acceptance for evaluation of its MAA – a major step in our development,” said Michel Feraud, chief executive of Provepharm.
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