Navigation Links
Tengion Announces European Orphan Drug Designation for Neo-Bladder Augment
Date:4/1/2008

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."

About Tengion

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.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Tengion Appoints Jeff Randall to Board of Directors
2. Tengion to Present at Merrill Lynch Global Pharmaceutical, Biotechnology & Medical Device Conference
3. Preclinical Efficacy Data Demonstrate Ability of Tengions Neo-Bladder Augment to Restore Bladder Function
4. DiObex Announces Presentation of Scientific Poster at Annual Meeting of American Society for Clinical Pharmacology and Therapeutics
5. DaVita Announces Retirement of Former Chief Medical Officer Charles J. McAllister, M.D.
6. Human Pheromone Sciences Announces Quarterly and Full Year Results
7. Dragon Pharma announces 2007 full year financial results
8. Genaera Corporation Announces 2007 Financial Results
9. Genmab Announces Year End 2007 Financial Results
10. Immunosyn Corporation Announces 2007 Results, Files 10KSB
11. Elbit Imaging Ltd. Announces Results For Fiscal Year 2007
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... June 24, 2016 Epic Sciences unveiled ... cancers susceptible to PARP inhibitors by targeting homologous ... (CTCs). The new test has already been incorporated ... multiple cancer types. Over 230 clinical ... response pathways, including PARP, ATM, ATR, DNA-PK and ...
(Date:6/23/2016)... , June 23, 2016   Boston Biomedical ... novel compounds designed to target cancer stemness pathways, ... been granted Orphan Drug Designation from the U.S. ... of gastric cancer, including gastroesophageal junction (GEJ) cancer. ... designed to inhibit cancer stemness pathways by targeting ...
(Date:6/23/2016)... MONICA, Calif. , June 23, 2016  The Prostate Cancer Foundation ... pioneer increasingly precise treatments and faster cures for prostate cancer. Members of the ... institutions across 15 countries. Read More About the Class ... ... ...
(Date:6/23/2016)... ... ... In a new case report published today in STEM CELLS Translational Medicine, doctors ... being treated for breast cancer benefitted from an injection of stem cells derived from ... frequent side effect of cancer treatment. , Lymphedema refers to the swelling ...
Breaking Biology Technology:
(Date:6/9/2016)... Finland , June 9, 2016 ... National Police deploy Teleste,s video security solution to ensure the ... France during the major tournament ... data communications systems and services, announced today that its video ... Prefecture to back up public safety across the ...
(Date:6/3/2016)... 2016 Das DOTM ... Nepal hat ein 44 Millionen ... Kennzeichen, einschließlich Personalisierung, Registrierung und IT-Infrastruktur, an ... und Implementierung von Identitätsmanagementlösungen. Zahlreiche renommierte internationale ... teilgenommen, aber Decatur wurde als konformste und ...
(Date:6/2/2016)...   The Weather Company , an IBM Business (NYSE: ... capability in which consumers will be able to interact with ... via voice or text and receive relevant information about the ... Marketers have long sought an advertising solution that can create ... relevant and valuable; and can scale across millions of interactions ...
Breaking Biology News(10 mins):