Regenerative medicine company Tengion Inc. (NSDQ:TNGN) has been granted orphan drug designation on its technology, originally developed to help patients with bladder cancer who have had their bladders removed.
Orphan drug status offers incentives for development of products that address rare, unmet medical needs that affect fewer than 200,000 patients in the U.S.
The U.S. Food & Drug Administration’s orphan drug designation for Tengion’s Neo-Urinary Conduit gives the company seven years of U.S. marketing exclusivity if it receives regulatory approval. The company could also get tax credits for clinical research expenses and a waiver of some FDA fees.
The East Norriton, Pa.-based regenerative medicines maker’s platform technology for organ regeneration can create organs and tissues that the body will recognize as its own. The technology is used to make functional tissue that can form a conduit that diverts urine from the ureters to a removable, disposable bag outside the body.
Patients who have their bladders removed currently have such conduits created from their bowel tissues, which raises several complications.
The technology is intended to offer an alternative to current practices of using tissue from one part of the body to replace tissue in another, which can cause complications. It could also be an alternative to organ donation, which requires life-long anti-rejection medicines.
The company has some big backers. Medical device goliath Medtronic Inc. (NYSE:MDT) revealed its 17 percent stake and a right of first refusal to purchase technology from Tengion earlier this year.
Tengion’s tissue generation technology is in a phase 1 clinical trial. You can watch a video of construction of a conduit here.