Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the European Commission (EC) has granted marketing authorization for NUMIENT (Levodopa and Carbidopa), a modified-release oral capsule formulation for the symptomatic treatment of adult patients with Parkinson's disease. The review of this application was conducted under the centralized licensing procedure as a therapeutic innovation, and is applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
"We are pleased that NUMIENT was approved by the European Commission as this not only showcases our R&D capabilities outside the US but is an additional positive review of our quality systems by another regulatory authority," said Fred Wilkinson, President and Chief Executive Officer of Impax. "NUMIENT addresses one of the most significant unmet needs for patients living with this disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled."
"This is our first branded drug approved for commercialization outside the United States and we are in active discussions with potential partners to support the commercialization of NUMIENT in Europe and the rest of the world. We are analyzing the options that will help facilitate the introduction of this product into the global market," concluded Mr. Wilkinson.
The EC decision is based on results from three Phase 3 controlled clinical studies which assessed the safety and efficacy of NUMIENT in patients with early (levodopa-naive) and advanced Parkinson's disease in the U.S. and in Europe.