Talecris Biotherapeutics has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the development of Plasmin (Human) to treat acute peripheral arterial occlusion (PAO). Talecris is currently investigating Plasmin in a phase I/II clinical trial designed to assess its ability to treat PAO, a condition in which arterial blood flow to the extremities, usually the legs, is blocked by a clot. Currently, there are no FDA approved treatments for acute PAO.

"We are extremely pleased to have received orphan drug designation for Plasmin, a development stage product that has the potential to significantly improve the treatment of this limb-threatening and life-threatening condition," said Steve Petteway, senior vice president, Research and Development, Talecris Biotherapeutics, "Talecris is dedicated to developing a safe, fast, and effective therapy to rapidly lyse clots."

Orphan drug designation is granted to companies to encourage the development of treatments that prevent, diagnose or treat rare, life-threatening or chronic illnesses that affect fewer than 200,000 people per year in the US. The designation provides incentives such as tax credits and potentially seven years market exclusivity to companies willing to support the costly research and development programs associated with developing specialized drugs for a small population of individuals.

Plasmin, derived from human plasma, is a stabilized formulation of the naturally-occurring blood enzyme that dissolves blood clots by breaking down the fibrin matrices to restore blood flow.