Provepharm, a French company specialized in the development of pharmaceutical applications announces that Daiichi Sankyo, Co. Ltd., a global pharmaceutical firm, has filed an NDA
For the development and marketing of the injectable Methylene Blue medicinal product in Japan, made out of Provepharm’s Proveblue(R) Methylene Blue active substance.
In November 2011, Provepharm out-licensed to Daiichi Sankyo the exclusive rights for developing and marketing its medicinal product in Japan. It is already approved by the European Medicines Agency for the treatment of metheamoglobinaemia induced by medicinal and chemical products. It is traded in Europe as ’Methylthioninium chloride Proveblue 5mg/ml solution for injection’.
Methylene Blue is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs set up by the Ministry of Health, Labour and Welfare in Japan. Daiichi Sankyo is committed to making this drug available to Japanese patients waiting for it to be approved.
Methaemoglobinaemia is a disorder characterized by an abnormal amount of methaemoglobin in the blood, leading to an inability to effectively release oxygen to body tissue. The disorder can be inherited or acquired after exposure to certain chemicals or drugs, for example: anaesthetics, certain antibiotics and nitrites which are used in the preservation of food.
Provepharm is a subsidiary of the Provence Technologies Group. It is specialized in the development and commercialization of pharmaceutical drug products derived from active pharmaceutical ingredients (APIs) synthesized and patented by its parent company. Anticipating the pharmaceutical industry’s needs, Provepharm adopted a strategy of repositioning and rehabilitating known compounds in new indications. This development strategy is designed to cater for the growing demand for APIs that must comply with current quality demands. The first compound offered is Methylene Blue.
For more information, please visit http://www.provepharm.com
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model", which will respond to market and customer diversity and optimize growth opportunities across the value chain.
For more information, please visit http://www.daiichisankyo.com