Phrixus Pharmaceuticals announces European Access Program for Carmeseal- MDTM (P-188 NF) for patients with Duchenne muscular dystrophy
Ethicor to distribute Carmeseal-MDTM (P-188 NF) in Europe for the treatment of respiratory and cardiac dysfunction in Duchenne muscular dystrophy (DMD)
ANN ARBOR, MI – 2 December 2014
Phrixus Pharmaceuticals, Inc. and Ethicor Pharma Ltd. today announced the initiation of their European Access Program (EAP) for Carmeseal-MDTM (P-188 NF). EAP is intended to make Carmeseal-MD available to patients with respiratory and cardiac deficits in DMD through their specialty physicians, primarily cardiologists and pulmonologists, as unlicensed medicinal product (‘Special’). In accordance with local regulations, Ethicor will make Carmeseal-MD available in January 2015 to such patients regardless of their genetic mutation. “For boys and young men with DMD and for their parents time is of the essence. We are committed to making Carmeseal-MD available to patients and their physicians using the most expeditious pathway available,” stated Thomas A. Collet, President and Chief Executive Officer of Phrixus Pharmaceuticals, Inc.
The underlying agreement provides Ethicor with the distribution rights to Carmeseal-MD in the European Union, with the possibility of an expansion to other regions of the world, excluding the United States, Canada and Mexico, prior to and until the registration of the product in the different countries covered by the agreement. Under the European medicines legislation (Directive 2001/83/EC, Article 5(1)), Ethicor will be able to supply, prior to regulatory approval, Carmeseal- MD as a “Special”. A “Special” may be requested by an authorized healthcare professional to meet the special needs of an individual patient under their direct responsibility. Specials cannot be actively promoted to healthcare professionals. Once Carmeseal-MD becomes an approved drug in a given country, the marketing rights to the approved product in that country revert back to Phrixus.