Singapore, Nov 29, 2011: Japan based Daiichi Sankyo has announced the execution of a license agreement for the development of Methylthioninium chloride solution for injection from PROVEPHARM SAS, France, for the treatment of life-threatening medicinal and chemical products induced methaemoglobinaemia in Japan.

The patients with the methaemoglobinaemia with increase of blood methaemoglobin concentration exhibit signs and symptoms such as cyanosis, headache, dizziness, shortness of breath, and loss of consciousness. Methylthioninium chloride has been approved by European Medicines Agency and used for the treatment of methaemoglobinaemia in EU as “Methylthioninium chloride Proveblue 5mg/ml, Solution for Injection”, but not in Japan.

This is one of the agents publicly offered for a development company by the Review Committee on Unapproved Drugs and Indications with High Medical Needs set up the Ministry of Health, Labour and Welfare. As a part of its CSR effort, Daiichi Sankyo is committed to making unapproved and off-label drugs available to patients who are waiting for them to be approved.

Working group held by the MHLW that aims to accelerate the development process for drugs not yet approved in Japan but which have been available in Europe and the U.S