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Tengion Announces FDA Orphan-Drug Designation for Neo-Urinary Conduit
Date:6/9/2011

EAST NORRITON, Pa., June 9, 2011 /PRNewswire/ -- Tengion, Inc. (Nasdaq: TNGN) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to the Company's Neo-Urinary Conduit™, for treatment of bladder dysfunction requiring incontinent urinary diversion.  

"This designation is another important step in advancing the development of our Neo-Urinary Conduit, our lead clinical product candidate, currently being studied in patients with bladder cancer," said Sunita Sheth, M.D., Chief Medical Officer of Tengion.  

Orphan drug designation entitles Tengion to seven years of U.S. marketing exclusivity for the Neo-Urinary Conduit if and when it receives regulatory approval, as well as additional incentives in the form of tax credits for clinical research expenses and a waiver of the FDA's application user fee. Orphan-drug status is granted by the FDA to promote the development of new therapies for medical conditions affecting fewer than 200,000 individuals in the United States.

About Tengion

Tengion, a clinical-stage biotechnology company, has pioneered the Organ Regeneration Platform™ that enables the Company to create proprietary product candidates that are intended to harness the intrinsic regenerative pathways of the body to produce a range of native-like organs and tissues. Tengion's product candidates seek to eliminate the need to utilize other tissues of the body for a purpose to which they are poorly suited, procure donor organs or administer anti-rejection medications.  An initial clinical trial is ongoing for the Company's lead product candidate, the Neo-Urinary Conduit, an autologous implant that is intended to catalyze regeneration of native-like bladder tissue for bladder cancer patients requiring a urinary diversion following bladder removal.  The Company's lead preclinic
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SOURCE Tengion, Inc.
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Related medicine technology :

1. Tengion Presents New Data in Nine Posters and Two Oral Presentations at TERMIS North America Annual Meeting
2. Tengion Advances Clinical Trial for Neo-Urinary Conduit™ in Bladder Cancer Patients
3. Tengion Provides Business Update and Reports Third Quarter 2010 Financial Results
4. Tengion Reviews Pipeline Progress at First Analyst and Investor Meeting; Strategic & Clinical Updates Provided for Regenerative Medicine Programs
5. Tengion Announces First Implantation of Neo-Urinary Conduit™ in Initial Clinical Trial in Patients with Bladder Cancer
6. Tengion Presents New Data Demonstrating Functional Regeneration in a Diabetic Chronic Kidney Failure Model at the International Society for Cellular Therapy
7. Tengion Appoints Sunita B. Sheth, M.D., Chief Medical Officer
8. Tengion Scientists Publish Key Preclinical Findings Demonstrating the Benefits of Organ Regeneration Vs. Repair
9. Preclinical Data Demonstrate Ability to Regenerate an Entire Bladder With Tengion Neo-Bladder Replacement(TM)
10. Tengion Launches Third Phase 2 Clinical Trial of Regenerated Human Bladder
11. Tengion Launches Second Phase 2 Clinical Trial of Regenerated Human Organ
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