Talecris Biotherapeutics has been granted orphan drug designation by the European Commission for the development of Plasmin (human) to treat acute peripheral arterial occlusion (aPAO). Talecris is currently investigating Plasmin in a phase II clinical trial designed to assess its ability to treat aPAO, a condition in which arterial blood flow to the extremities, usually the legs, is blocked by a clot.
The European Medicines Agency (EMA) will provide Talecris with 10 years of market exclusivity if the product is the first to be approved in the European Union. In addition, under this designation EMA will provide Talecris with clinical development assistance and reduced regulatory fees. Talecris received orphan drug designation for Plasmin from the FDA in 2009.
"The European Commission's orphan drug designation represents another promising development milestone for Talecris in the expansion of our product pipeline, a pursuit that reflects our ongoing commitment to offer clinical advancements for patients with chronic and acute life-threatening conditions," said Steve Petteway, executive vice president, research and development at Talecris.
By providing incentives to the pharmaceutical industry, the EU legislative framework for orphan medicines encourages the development of products intended to diagnose, prevent and treat life-threatening or chronically-debilitating conditions that impact up to five in 10,000 people in the European Union. The initiative helps improve access to quality medical care for patients who have rare diseases for which there are few, if any, approved treatments.