EAST NORRITON, Pa., June 9, 2011 /PRNewswire/ — Tengion, Inc.
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
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