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DOR BioPharma Announces Potential $30 Million North American Partnership Agreement with Sigma-Tau Pharmaceuticals for orBec(R) in the Treatment of Graft-versus-Host Disease
Date:2/12/2009

dipropionate (BDP) is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma. orBec(R) is formulated for oral administration as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract, and the other tablet is intended to release BDP in the distal portions of the GI tract.

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to DOR, orBec(R) also benefits from orphan drug designations in the US and in Europe for the treatment of GI GVHD, which provide for seven and 10 years of post-approval market exclusivity, respectively.

About GI GVHD

GI GVHD is a debilitating and painful disease and constitutes an unmet medical need. It is a life-threatening condition and one of the most common causes for bone marrow and stem cell transplant failure. It is a common disorder among immunocompromised cancer patients after receiving hematopoietic cell transplantation. These procedures are being increasingly used to treat patients with leukemia and other cancers to eliminate residual disease and reduce the likelihood of relapse. Unlike organ transplants where the patient's body may reject the organ, in GVHD it is the donor cells that begin to attack the patient's (host's) body - most frequently the gastrointestinal tract, liver and skin. Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea. If left untreated, GI GVHD can progress to ulcerations in the lining of the GI tract, and in its most severe form, can be fatal. orBec(R) represents a novel oral, locally active therapy and is intended to red
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SOURCE DOR BioPharma, Inc.
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