DOR BioPharma, Inc. Files New Drug Application With FDA To Market orBec For GI GVHD; First GI-Directed Therapy To Treat The Most Common Life Threatening Complication Of Hematopoietic Stem Cell Transplantation

MIAMI--(BUSINESS WIRE)--Sept. 22, 2006--DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company"), announced today that it has submitted in the Electronic Common Technical Document format a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") to market orBec(R) (oral beclomethasone dipropionate) for the treatment of gastrointestinal Graft-versus-Host disease ("GI GVHD"), the most common life-threatening complication of allogeneic hematopoetic stem cell transplantation. orBec(R) is a two pill system containing the highly potent topically active corticosteroid beclomethasone dipropionate designed to specifically target and treat upper and lower GI GVHD with reduced systemic immunosuppressive side effects. Systemic immunosuppressive agents, such as prednisone, that are currently the standard treatment for GI GVHD are associated with high rates of mortality due to infection and debility. orBec(R) has previously been granted Fast Track designation for the treatment of GI GVHD by the FDA and thus may qualify for priority review.