A blood clot treatment being developed by Talecris Biotherapeutics has received an orphan drug designation from European regulators.
Research Triangle Park, North Carolina-based Talecris (NASDAQ:TLCR) is studying Plasmin in phase II clinical trials to assess its ability to treat acute peripheral arterial occlusion, or aPAO. The condition occurs when blood flow to the extremities, usually the legs, is blocked by a blood clot. It is most common in people with underlying peripheral artery disease.
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APAO can result in permanent nerve and muscle damage, the death of cell and tissue, and in severe cases, amputation or death. Current aPAO treatments use drugs or surgery. The existing drug treatments can increase the risk of bleeding complications. The Talecris compound Plasmin is a stabilized formulation of the naturally occurring blood enzyme plasmin, which dissolves blood clots. It is being investigated for its ability to restore blood flow.
Orphan drug status is reserved for new drugs that treat rare conditions where there is an unmet medical need. Regulatory agencies offer companies incentives to encourage development of new drugs for such conditions. The European Medicines Agency will give Talecris 10 years of market exclusivity if Plasmin is the first aPAO product to be approved in the European Union. The EMA will also provide Talecris clinical development assistance and reduced regulatory fees.
Talecris received U.S. orphan drug designation for Plasmin from the U.S. Food and Drug Administration in 2009.
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