Provepharm has announced that it has just received official marketing authorization for its Methylthioninium Chloride Proveblue from the European Medicines Agency.
This authorization means that clinicians will be able to treat European patients for the first time with this injectable drug based on the active principal methylthioninium chloride Proveblue™ (or methylene blue), which embodies the quality and safety characteristics currently required of a pharmaceutical product.
The active principal Proveblue™ is the only methylene blue in the world that is compliant with the monograph of the European pharmacopoeia and to ICH Q3A standards on impurities in new active substances. It has a very high degree of purity and is virtually free of metallic contaminants such as heavy metals.
Securing European marketing approval is a major milestone for Provepharm in commercial development terms. It effectively gives the company access to the markets of all 27 European Union countries, as well as the three countries linked to the EU (Norway, Iceland and Liechtenstein).
Furthermore, it will give a major boost to its plans for extending the product’s commercialization to the world market, as well as being a significant asset for developing other pharmaceutical applications.
Provepharm’s European Marketing Authorization Application (MAA) for Proveblue™ already prompted a leading Japanese pharmaceutical company to carry out a general audit, including the supply chain, and this company has just confirmed its wish to acquire exclusive rights to the product for the Japanese market.
In the United States, where no marketing authorization has yet been granted for injectable products based on methylene blue, several candidates have already expressed an interest in Proveblue™.
Over and beyond these key markets, Provepharm has already made contact with several companies on other continents, which opens up the possibility of international coverage and confirms the potential of Proveblue™.
The new process utilized to produce Proveblue™, which has greatly reduced the organic and inorganic impurities (heavy metals), is a perfect illustration of the innovative nature of the paths and processes used by Provepharm.
“For that reason, we are convinced that other Proveblues exist in the form of ‘abandoned products’ and that it is possible to give them a second life,” said the chairman of Provepharm, Michel Féraud. “Our researchers are all working on other products as well.”
Provepharm is preparing to create another three or four posts to handle the marketing of Proveblue™ at a European level.