Talecris Biotherapeutics Receives EU Orphan Drug Designation for Plasmin (Human) as a Treatment for Acute Peripheral Arterial Occlusion
Published: Mar 04, 2011
RESEARCH TRIANGLE PARK, N.C., March 3, 2011 /PRNewswire/ -- Talecris Biotherapeutics, Inc. (TLCR) announced today that it 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.
Through this designation, the European Medicines Agency (EMA) will provide Talecris with ten 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 U.S. Food and Drug Administration (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 5 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.
Plasmin is a stabilized formulation of the naturally-occurring blood enzyme Plasmin, which dissolves blood clots by breaking down their fibrin matrices and is being investigated for its ability to restore blood flow. Plasmin, derived from human plasma, is a direct-acting thrombolytic that exerts its effects directly at the site of the clot. In contrast, indirect-acting thrombolytics, such as Plasminogen activators, target clots indirectly by first stimulating the production of Plasmin.
Talecris recently completed a phase I/II multicenter clinical trial to investigate dose escalation and safety in the treatment of acute PAO. Study participants received Plasmin via catheter directly infused to the site of the clot. A phase II multicenter clinical trial has been initiated.
About Acute Peripheral Artery Occlusion (PAO)
Acute peripheral arterial occlusion (aPAO) 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 and cause 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 up to 1.7 per 10,000 people in the European Union 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 direct-acting thrombolytic drugs currently approved for this indication, and the treatments currently used (Plasminogen activators) typically require a prolonged infusion averaging 24 to 36 hours, which can increase the risk of bleeding complications.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics (Nasdaq: TLCR) 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, pulmonology, neurology and hemostasis. (http://www.talecris.com/)
Cautionary statement regarding forward-looking statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, quotations from management in this press release, statements regarding strategic and operation plans, and statements regarding the development or commercialization of therapies. Forward-looking statements are based on current beliefs and expectations and are subject to inherent risks and uncertainties. You are cautioned not to place undue reliance on forward-looking statements. Although Talecris believes that the forward-looking statements contained in this press release are reasonable, there is no assurance that expectations will be fulfilled.
The following factors, among others, could cause actual results to differ materially from those expressed or implied in forward-looking statements: possible U.S. legislation or regulatory action affecting, among other things, the U.S. healthcare system, pharmaceutical pricing and reimbursement, including Medicaid and Medicare; our ability to procure adequate quantities of plasma and other materials which are acceptable for use in our manufacturing processes from our own plasma collection centers or from third-party vendors; our ability to maintain compliance with government regulations and licenses, including those related to plasma collection, production and marketing; our ability to identify growth opportunities for existing products and our ability to identify and develop new product candidates through our research and development activities; and the timing of, and our ability to, obtain and/or maintain regulatory approvals for new product candidates, the rate and degree of market acceptance, and the clinical utility of our products. Additional information about factors that could affect the business and financial results of Talecris is contained in its final Prospectus filed pursuant to Rule 424(b)(1) with the Securities and Exchange Commission on October 1, 2009. Talecris undertakes no duty to update any forward-looking statement.
SOURCE Talecris Biotherapeutics, Inc.