Novasep, a leading supplier of manufacturing solutions to the life sciences industries, and Provepharm, a start-up specialized in the development of pharmaceutical applications for Proveblue, announced the successful validation by Novasep of a cGMP manufacturing process for the Proveblue active pharmaceutical ingredient. This is a major step in bringing compliant methylene-blue-based drugs to market.
At the same time, Provepharm announces that the European Medicines Agency (EMEA) has accepted for evaluation the Marketing Authorisation Application (MAA) for Provepharm’s Methylthioninium chloride Proveblue solution for injection under the Community centralized procedure.
Patented and compliant Proveblue active pharmaceutical ingredient (API) opens the way to researching and developing methylene-blue-based drug products in a variety of applications, including urinary and ocular antiseptics as well as anti-malarial agents.
Methylene blue is widely used as a dye in therapeutic and diagnostic applications. But, until now, it has existed only in highly impure form and generally contains high levels of heavy metals that are toxic in patients. Proveblue, developed by Provepharm, is the first methylene blue API to allow pharmaceutical and medical device manufacturers to offer methylene blue products with improved risk/benefit ratio.
Proveblue API complies with regulatory standards, worldwide. It is the first grade of methylene blue compliant with the European Pharmacopoeia and International Conference on Harmonisation requirements. It also complies with the EMEA Guideline on the specification limits for residues of metal catalysts.
The acceptance by the EMEA of the Methylthioninium chloride Proveblue solution for injection MAA under the Community centralized procedure means fast evaluation and if accepted will result in a single authorization covering EU’s 27 countries.
Part of the challenge in bringing this distinguishing product to market lay in developing and implementing a manufacturing process to reduce impurities in the API. The process developed by Provepharm and implemented by Novasep results in up to 100 times fewer metal impurities and significantly improved organic purity.
Provepharm turned to Novasep in February 2009 to undertake the scale-up of its original synthesis process. Novasep committed to this challenge and dedicated a project team at its Chasse sur Rhône facility near Lyon, France to tackle this fast-track project. Novasep successfully scaled up this challenging chemistry, including the development and/or transfer of complex analytical methods, and was able to validate the process in September 2009, only six months after being instructed by Provepharm. In October 2009, Novasep was successfully inspected by the French Medicines Agency (AFSSAPS) for this process.
“Solving the tough industrialization 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, CEO of Provepharm. “Novasep showed great expertise and technical performance as well as 100 per cent commitment to the project. Novasep is to be congratulated for its results-oriented approach.”
“We are delighted to have been able to help Provepharm make this highly significant breakthrough,” said René de Vaumas, executive VP in charge of Novasep Synthesis Sales and R&D. “Provepharm’s grasp of development and regulatory processes has enabled us to jointly prepare all the data for the filing of the MAA and the drug master files in less than a year. This is a particularly good example of Novasep’s core expertise and ability to resolve challenging synthesis and purification projects, and bring them to industrial scale in a timely manner. We look forward to the commercial success of this project.”
Novasep develops, markets and operates innovative technologies providing life science industries with safe and cost-effective production of active molecules.
Provepharm is an affiliated company of the Provence Technologies Group, devoted to developing and marketing pharmaceutical drug products from active pharmaceutical ingredients synthesized and patented by its parent company.