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:12/6/2016)... ... December 06, 2016 , ... ... platforms, announced today that the company has engaged in a collaborative research partnership ... (MRDA) with the CSU Office of the Vice President for Research. This agreement ...
(Date:12/6/2016)... WARSAW, Ind. , Dec. 6, 2016 ... (the "Company") today announced the pricing terms of ... up to $1.25 billion aggregate purchase price (excluding accrued ... applicable settlement date and excluding fees and expenses ... of the debt securities identified in the table ...
(Date:12/6/2016)... ... December 06, 2016 , ... RoviSys, a leading ... in Aurora, Ohio, announced the opening of their new office building today. Located ... facility is home to 200 employees focused on providing sales, engineering, and support ...
(Date:12/5/2016)... ... December 05, 2016 , ... The Real Dirt ... premier cannabis technology and application experts, Chip Baker. Chip Baker formerly co-founded Royal ... the past 30 years, Chip Baker other industry veterans have made the evolution ...
Breaking Biology Technology:
(Date:12/6/2016)... , Dec. 6, 2016 Valencell , the ... it has seen a third consecutive year of triple ... technology in 2016 with a 360 percent increase in ... This increase was driven by sales of its wrist ... interest in its technology for hearables for fitness and ...
(Date:12/2/2016)... India , December 1, 2016 ... Authentication type (Fingerprint, Voice), Future Technology (Iris Recognition ... and Region - Global Forecast to 2021", published ... USD 442.7 Million in 2016, and is projected ... at a CAGR of 14.06%.      ...
(Date:11/30/2016)... 2016  higi SH llc (higi) announced today ... national brands, industry thought-leaders and celebrity influencers looking ... for taking steps to live healthier, more active ... higi has built the largest self-screening health station ... people who have conducted over 185 million biometric ...
Breaking Biology News(10 mins):