Tengion Announces Expanded European Orphan Medicinal Product Designation For Neo-Bladder Augment

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals;  Neurology / Neuroscience
Article Date: 22 Sep 2008 - 7:00 PDT

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Tengion Inc., a clinical stage regenerative medicine company focused on the development of neo-organs and neo-tissues, today announced that the European Medicines Agency (EMEA) and the European Commission (EC) have formally designated the Tengion Neo-Bladder Augment™ as an Orphan Medicinal Product for the treatment of neurogenic bladder associated with spinal cord injury. This expands the Tengion Neo-Bladder Augment's existing orphan designation. Tengion announced in April 2008 that its Neo-Bladder Augment was granted EMEA and EC orphan designation for the treatment of neurogenic bladder in spina bifida patients.

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 European marketing exclusivity upon marketing approval.

Spinal cord injuries can cause neurogenic bladder, a condition that can lead to kidney failure and incontinence, even when patients receive optimal medical treatment. Although satisfactory methods of treatment for neurogenic bladder have been authorized by EMEA, Tengion's Neo-Bladder Augment may provide significant clinical benefit to those spinal cord injury patients who suffer from neurogenic bladder and warrant surgical intervention for their condition.

"We are extremely pleased that EMEA and the European Commission have further recognized the Neo-Bladder Augment's potential to significantly improve the treatment of neurogenic bladder, in this case in patients with spinal cord injury," said Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion. "We look forward to continuing to work with the EMEA, as well as with the U.S. Food and Drug Administration, to move our neo-organs through the respective regulatory pathways."

About Tengion

Tengion, a clinical stage regenerative medicine company, focuses on developing, manufacturing and commercializing human neo-organs and neo-tissues using our Autologous Organ Regeneration Platform™. Tengion uses biocompatible materials and a patient's own (autologous) cells to create a functional neo-organ or neo-tissue that is designed to catalyze 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. www.tengion.com