Pervasis Case Study

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Pervasis Receives Orphan Drug Designation in Europe for Vascugel® to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis Cell-Based Therapy Aims to Regulate the Body’s Healing Response, Promoting Vascular Repair, Reducing the Need for Repeat Surgical Procedures and Improving Patient Outcomes Cambridge, Mass., March 1, 2011 — Pervasis Therapeutics, Inc. announced today that the European Commission (EC) has granted Orphan Drug Designation for Vascugel® for the prevention of hemodialysis vascular access failure in patients with end stage renal disease (ESRD). The designation follows a positive opinion from The Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) earlier this year. Vascugel is a novel endothelial cell-based therapy that aims to regulate the body’s healing response following surgical interventions to create vascular access which are necessary for ESRD patients undergoing hemodialysis. By promoting and enhancing vascular repair, Vascugel reduces the need for repeat surgical interventions and improves overall patient outcomes. ESRD is an advanced and irreversible condition treated mainly by hemodialysis or kidney transplantation. It is estimated that more than 250,000 ESRD patients in the EU receive hemodialysis, a blood purification therapy designed to replace critical kidney functions – such as filtering waste. Orphan Drug Designation by the EC provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU). In addition to a 10year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation provides companies with scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, as well as reductions in certain fees....
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