DOR BioPharma to File NDA for orBec'R'.

MIAMI -- DOR BioPharma, Inc. (AMEX: DOR) ("DOR" or the "Company") announced its intention to file a new drug application (NDA) with the FDA for orBec(R) (oral beclomethasone dipropionate) for the treatment of intestinal Graft-versus-Host Disease (iGVHD), a common serious complication of bone marrow transplantation for cancer. The decision follows recent correspondence and a pre-NDA meeting with the FDA.

"We are very encouraged by our meeting with the FDA," stated Michael Sember, President and Chief Executive Officer of DOR. "We are excited with the results of our pivotal Phase III clinical trial. In addition to the strong positive trends on our primary endpoint of median time to treatment failure at study Day 50 in our pivotal trial, we saw a statistically significant result in median time to treatment failure at study Day 80 (p-value 0.0226). This result, combined with a highly statistically significant outcome and approximately 70% reduction in the prospectively defined secondary endpoint of mortality at 200 days post transplant (p-value 0.006), has given us confidence in the consistency and clinical durability of activity of orBec(R). We believe that our pivotal Phase III clinical trial of orBec(R) and collectively all the clinical data before it, clearly demonstrate a clinical benefit to patients with no other alternative except high dose systemic corticosteroids. Our immediate priorities are to assemble a high quality data package to support the filing of an NDA as soon as possible but by the fourth quarter of 2005, and to submit the results of the pivotal trial for publication in a prominent peer-reviewed publication. We will also take steps to prepare for submission of a Marketing Authorization Application (MAA) with the European Medicines Evaluation Agency (EMEA)."

orBec(R) has previously been granted Orphan Drug Designation and has received "Fast Track" designation from the FDA.

George B. McDonald, MD, Head of the Gastroenterology/Hepatology Section at the Fred Hutchinson Cancer Research Center in Seattle, inventor of orBec(R), and a consultant to DOR stated, "Those working in the field of hematopoietic cell transplantation have long recognized that prolonged exposure to prednisone in patients with iGVHD led not only to weakness, debility, and changes in body habitus, but also to viral, bacterial, and fungal infections. The pivotal Phase III study provides a clear rationale for the use of orBec(R) in the treatment of iGVHD; control of iGVHD with an oral topical corticosteroid leads to less prednisone exposure, less systemic immunosuppression, fewer fatal infections, and possibly an enhanced graft-versus-leukemia (GVL) effect. The frequency of leukemic relapse after allogeneic hematopoietic cell transplant is lower in patients who experience GVHD after transplant, a phenomenon called the GVL effect. We hypothesize that avoidance of prolonged prednisone exposure preserves the GVL effect, resulting in fewer relapses of leukemia. orBec(R) appears to be safe. Thus, the benefit-to-risk ratio for the use of orBec(R) in the treatment of iGVHD seems strongly in favor of benefit. orBec(R) addresses the unmet medical need for an effective adjunctive therapy for iGVHD with minimal side effects."

About Intestinal Graft-versus-Host Disease

iGVHD is a life threatening condition that is one of the most common causes for the failure of bone marrow transplant procedures. These procedures are being increasingly utilized to treat leukemia and other cancer patients with the prospect of eliminating residual disease and reducing the likelihood of relapse. orBec(R) represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic. orBec(R) is intended to reduce the need for systemic immunosuppressive drugs to treat iGVHD.

About orBec(R)

orBec(R), if approved by the FDA, would be the first oral formulation of beclomethasone dipropionate (BDP) available in the United States. BDP is a highly potent, topically-active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the U.S. and worldwide since the early 1970's as a nasal spray and in a metered dose inhaler for the treatment of patients with allergic rhinitis and asthma. orBec(R) is delivered to the gastrointestinal (GI) tract for topical treatment of inflammation within the mucosal tissue. orBec(R) is being developed as a two-pill system with dual release characteristics that initially begins to release BDP in the stomach, and continues to release BDP as it travels down the GI tract for broader coverage in the intestines.

Prior Study Results

orBec(R) was previously tested in a randomized, double blind, placebo-controlled Phase II study (Gastroenterology, 1998; 115: 28-35). In that study, 60 patients with iGVHD were randomized to receive conventional prednisone therapy plus either orBec(R) or placebo. Initial responders continued to take orBec(R) or placebo for an additional 20 days, during which time the conventional therapy was rapidly tapered. The primary endpoint for this study was the clinically relevant determination of whether iGVHD patients at Day 30 were or were not able to consume at least 70% of their daily caloric intake by mouth, as compared to intravenous parenteral nutrition administered in the hospital. The treatment response at Day 30 was 22 of 31 (71%) vs. 12 of 29 (41%) in the orBec(R) and placebo groups respectively, achieving a statistically significant p-value of 0.02.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. is a biopharmaceutical company focused on the development of biomedical countermeasures and therapeutic products for areas of unmet medical need. Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the paradigm established by the recently enacted Project BioShield Act of 2004. Our biodefense products in development are bioengineered vaccines designed to protect against the deadly effects of ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine is currently the subject of a Phase I clinical trial in normal volunteers. We have also recently announced the initiation of a new botulinum toxin therapeutic development program based on rational drug design.

Through our BioTherapeutics Division, we are developing oral therapeutic products to treat unmet medical needs. Our lead product, orBec(R) (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of iGVHD as well as other gastrointestinal disorders characterized by severe inflammation. For further information regarding DOR BioPharma, please visit the Company's website located at http://www.dorbiopharma.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma's current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec(R) for the treatment of iGVHD and the prospects for regulatory filings for orBec(R). Where possible, DOR BioPharma has tried to identify these forward-looking statements by using words such as "anticipates", "believes", "intends", or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR BioPharma cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec(R), particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its technologies will prove to be safe and effective (including that the results of its Phase I clinical trial of RiVax(TM) will demonstrate acceptable safety and immunogenicity/efficacy), that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, that it will be able to maintain its listing on the American Stock Exchange, or that its business strategy will be successful. Important factors which may affect the future use of orBec(R) for iGVHD include the risks that: because orBec(R) did not achieve statistical significance in its primary endpoint in the pivotal Phase III clinical study (i.e. a p-value of less than or equal to 0.05), the FDA may not consider orBec(R) approvable based upon existing studies, orBec(R) may not show therapeutic effect or an acceptable safety profile in future clinical trials, if required, or could take a significantly longer time to gain regulatory approval than DOR BioPharma expects or may never gain approval; Dor BioPharma is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; or orBec(R) may not gain market acceptance; and others may develop technologies or products superior to orBec(R). These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR BioPharma's most recent reports on Form 10-QSB and Form 10-KSB. DOR BioPharma assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, and changes in circumstances or for any other reason.