DOR Dor Biopharma

DOR BioPharma, Inc. (AMEX:DOR) ("DOR", or the "Company") announced today that it is focusing its resources on the preparation of New Drug Application ("NDA") and Marketing Authorization Application ("MAA") submissions and potential regulatory approvals for orBec(R) for the treatment of intestinal Graft-versus-Host disease ("iGVHD"). The Company is also providing guidance regarding its projected rate of cash expenditures for 2006. The Company believes it can achieve its current strategic goals for the year with average quarterly cash expenditures of approximately $800,000, or about $270,000 per month, although first quarter expenditures will likely be a little higher. Following the Company's November 1st 2005 pre-NDA meeting with the FDA's Oncology drug products division, DOR's target for submission is by the end of the first quarter of 2006. In addition, the Company is preparing a regulatory filing for Europe that it expects will be submitted before the end of the second quarter of 2006. Earlier this week, the Company had a pre-submission meeting in London with the EMEA. The meeting was an important procedural one which provided the Company with authoritative procedural, regulatory and legal advice on the filing. The Company will continue to work closely with the EMEA in the coming months as it prepares its MAA filing. Michael Sember, President and Chief Executive Officer of DOR commented: "We remain highly enthusiastic about orBec(R) and its prospects and we are diligently preparing both an NDA and well as an MAA. Our meeting with the FDA oncology products division on November 1st and the subsequent meetings with the German, French and UK regulatory authorities were encouraging and instructive. Our goal continues to be the submission of both high quality dossiers in as timely a fashion as possible. Additionally, we are taking steps to broaden the indications for orBec(R) beyond the treatment of iGVHD." When approved, orBec(R) will be indicated for use in iGVHD associated with allogeneic bone marrow or stem cell transplant (BMT/SCT) procedures. Based on the latest statistics available we estimate there are approximately 12,000 such procedures annually in the U.S. and a comparable number in Europe. Estimates as to the annual rate of increase in these procedures vary between 2% and 20%. High rates of morbidity and mortality occur in this patient population. The successful treatment of iGVHD represents an important unmet medical need. The FDA has previously granted orBec(R) both orphan drug designation and Fast Track Designation. Once the NDA is submitted, DOR believes orBec(R) may qualify for six month priority review from the date of filing. BMT/SCT is a very costly procedure and requires an intensive use of healthcare resources. Transplant centers are usually reimbursed at a fixed rate of approximately $250,000 per procedure and this is intended to cover all of a patient's follow-up care. Re-hospitalization of these patients can put a significant strain on the financial resources of these hospitals. For example, it is estimated that a single readmission of these patients can cost the institution between $14,000 and $50,000 and in the case of iGVHD patients are generally hospitalized while they rely on parenteral nutrition for sustenance. Under current standard of care, these patients have a high rate of readmission due to relapse of iGVHD or leukemia. These factors contribute to the high rate of mortality in iGVHD patients and if the patients become terminal and enter critical care, the costs mount quickly. In two separate randomized, double-blinded, placebo-controlled trials in iGVHD, orBec(R) has shown an approximately 70% reduction in mortality as well as a significant reduction iGVHD relapse rates in the pivotal trial. About DOR BioPharma, Inc. DOR BioPharma, Inc. is a biopharmaceutical company addressing life-threatening side effects of cancer and cancer treatments, serious gastrointestinal diseases and disorders, and biomedical countermeasures. Our lead product, orBec(R) (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host disease (iGVHD), a common serious complication of bone marrow transplantation for cancer, as well as other GI disorders characterized by severe inflammation. We plan to file a new drug application (NDA) with the FDA for orBec(R) for the treatment of iGVHD in the first quarter of 2006. 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, RiVax(TM), has completed the clinical portion of its Phase I clinical trial in normal volunteers. We have also announced the initiation of a new botulinum toxin therapeutic development program based on rational drug design. 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, 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 ("AMEX") by completing a transaction which will provide it with shareholders' equity of at least $6 million, 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). DOR BioPharma presently is involved in financing negotiations which could result in the issuance of a significant number of shares of its equity securities, thereby diluting the equity interests of present stockholders. 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.