European Medicines Agency (EMEA) Grants Orphan Drug Status for the
Treatment of Spina Bifida
EAST NORRITON, Pa., April 1 /PRNewswire/ -- Tengion Inc. announced today that the European Medicines Agency (EMEA) and the European Commission (EC) have formally designated Tengion's autologous urothelial and smooth muscle cells -- the Neo-Bladder Augment(TM) -- as an Orphan Medicinal Product for the treatment of spina bifida.
This Orphan Medicinal Product Designation qualifies Tengion and its Neo- Bladder Augment for EMEA regulatory incentives, including eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees. Orphan Product designation also enables the Neo-Bladder Augment to qualify for 10 years of marketing exclusivity in the EU upon marketing approval.
In accordance with directives set forth by the European Commission, EMEA's Committee for Orphan Medicinal Products (COMP) agreed that Tengion's Autologous Neo-Bladder Construct meets the criteria for being designated as an EU Orphan Medicinal Product, for the treatment of spina bifida. Spina bifida is a debilitating illness that frequently results in neurogenic bladder. Although satisfactory methods of treatment for the neurogenic bladder have been authorized by EMEA, justifications have been provided that the Neo- Bladder Augment may be of significant clinical benefit to those patients with spina bifida who suffer from neurogenic bladder and warrant surgical intervention for their condition.
"We are extremely pleased that EMEA and the European Commission has recognized the Neo-Bladder Augment's potential to significantly improve the treatment of neurogenic bladder in spina bifida patients -- a critically underserved patient population," said Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion. "We look forward to continuing to work with the EMEA, as we are with the U.S. Food and Drug Administration, to determine the most effective and efficient regulatory path forward for our neo-organs and neo-tissues."
Tengion, a clinical stage biotechnology company, focuses on developing, manufacturing and commercializing human neo-organs and neo-tissues using our Autologous Organ Regeneration Platform(TM). Tengion uses biocompatible materials and a patient's own (autologous) cells to create a functional neo- organ or neo-tissue that is designed to harness an individual's ability to regenerate specific organ tissue, catalyzing the body's innate ability to regenerate. Tengion's product candidates may ultimately address the most critical problems facing organ and tissue failure patients, enabling people to lead healthier lives without donor transplants or the side effects of related therapies. For more information on the company and current clinical trials, visit Tengion online at: http://www.tengion.com.
|SOURCE Tengion Inc.|
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