Healthcare Industry News: orphan drug designation
News Release - June 9, 2009
Talecris Biotherapeutics Receives Orphan Drug Designation for Plasmin (Human) to Treat Acute Peripheral Arterial OcclusionRESEARCH TRIANGLE PARK, N.C.--(HSMN NewsFeed)--Talecris Biotherapeutics, Inc. today announced that it has been granted orphan drug designation by the U.S. 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 U.S. 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.
About Acute Peripheral Artery Occlusion (PAO)
Acute Peripheral Arterial Occlusion (PAO) occurs when blood flow to the extremities becomes blocked by a blood clot. This condition is most common in people with underlying peripheral artery disease, in which fatty plaque builds up in artery walls causing narrowing of the arteries and restricted blood flow to legs and arms. Without prompt intervention, acute PAO can result in significant complications such as permanent nerve and muscle damage, tissue necrosis, and in severe cases, amputation or death.
There is an unmet medical need for a proven thrombolytic agent to treat acute PAO which affects approximately 100,000 people in the United States each year. Current methods focus on pharmacologic, mechanical, or surgical removal of the blood clot, or bypass grafting to direct flow around the area of the clot. However, there are no clot-busting drugs currently approved for this indication, and the treatments currently used (plasminogen activators) typically require a prolonged infusion averaging 24 to 36 hours and produce increased risk of bleeding complications.
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. Plasmin is delivered via catheter directly to the site of the clot. Plasmin is a direct-acting thrombolytic, in contrast to plasminogen activators, which act indirectly by stimulating the production of plasmin.
Safety and dosing results from the first clinical trial of Plasmin in humans, a Phase I/II study in hemodialysis graft occlusion, have recently been published (Shlansky-Goldberg et al., J Thromb Haemost 2008; 6: 944-950).
Plasmin is now being tested in a phase I/II multicenter clinical trial to investigate dose escalation and safety of Plasmin in acute PAO. Additional study outcomes to be assessed include Plasmin’s ability to restore blood flow and avoidance of a surgical procedure to restore blood flow.
Plasmin is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, neurology, pulmonology, and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.
Talecris, with revenues of approximately $1.4 billion in 2008, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 4,500 talented people worldwide. To learn more about Talecris and how its employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.
Source: Talecris Biotherapeutics
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