Proveblue(R) is the methylthioninium chloride or Methylene Blue active substance patented by Provepharm, compliant with current European Pharmacopeia standards
Provepharm, a French company specialized in the development of pharmaceutical applications, and Dr Franz Kohler Chemie (DFKC), a German leader in the manufacture and supply of organ preservation solutions and antidote pharmaceuticals, today announce that they have entered into a partnership to launch Provepharm’s drug product Methylthioninium chloride Proveblue 5mg/ml solution for injection (the Product) in Germany, for the acute symptomatic treatment of medicinal and chemical products-induced methaemoglobinaemia.
Under the agreement, DFKC is responsible for all commercial activities relating to the Product in Germany.
The Provepharm Proveblue(R) Methylene Blue active substance is the first Methylene Blue grade to meet European Pharmacopeia standards. It has enhanced purity in comparison to previous methylthioninium chlorides, which are generally of USP (United States Pharmacopeia) grade. The Product made of that substance gained approval by the European Medicines Agency in May 2011. It represents an improvement in quality compared to other methylthioninium chloride injectable drug products.
Additional benefits of the Product include an indication for chemical products-induced methaemoglobinaemia, as well as acute symptomatic treatment of medicinal products-induced methaemoglobinaemia and the indication to treat children and adolescents (aged 0-17 years old) as well as adults.
Methaemoglobinaemia is a life-threatening blood 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.
“We are pleased to be collaborating with DFKC which has such a good understanding of the antidotes market in Germany and we appreciate Dr G. Kohler’s decision to make the medicinal product available to German users and patients,” says Michel Feraud, CEO and founder of Provepharm.
“We are delighted to be collaborating with Provepharm with whom we share similar values and goals. The launch of the medicinal product in Germany contributes to our company’s strategy to launch products responding to medical needs,” says Dr Gernot Kohler, CEO of DFKC.