DOR Dor Biopharma

DOR BioPharma, Inc. (AMEX:DOR) ("DOR" or the "Company"), announced today that following written communications and meetings with the FDA and with the comparable regulatory authorities of the German, French and UK governments, it has established an expanded strategy for the submission of a New Drug Application (NDA) and Marketing Authorization Application (MAA) for orBec(R) for the treatment of intestinal Graft-versus-Host disease ("iGVHD"). Following a meeting on November 1, 2005 with the Division of Drug Oncology Products at the FDA, DOR intends to submit the NDA for orBec(R) in the United States in early 2006. On November 3rd, 4th and 7th, DOR met with the Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM) in Germany, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSaPS) in France, and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK respectively. Based on these meetings, which followed submission of a pre-meeting package, DOR has determined to submit an MAA to the centralized European Agency for the Evaluation of Medicinal Products (EMEA) in the first half of 2006. Michael T. Sember, President and CEO of DOR commented, "This was our first meeting with the Oncology Division following the transfer of reviewing responsibility from the Gastrointestinal Division. The meeting was very productive and provided DOR with valuable advice, particularly with regard to the Division's current weighting of the net clinical benefit of a product addressing an unmet medical condition such as iGVHD. The Division has informed us that the mortality results of the pivotal trial are of particular importance for their review of the NDA and they have asked for additional mortality information which we will provide. We were also very pleased with the cooperation and helpful advice of the European authorities and have thus decided to move ahead with the MAA filing ahead of our previous plans." In conjunction with our plans for submission of the MAA in Europe, we have increased our commercial activities in Europe and are now in discussions with a number of parties regarding a potential licensing arrangement. About DOR BioPharma, Inc. DOR BioPharma, Inc. is a biopharmaceutical company focused on the development of therapeutic products and biomedical countermeasures for areas of unmet medical need. 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 early 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 prior to a date set by AMEX for a hearing regarding the continued listing on AMEX of DOR BioPharma's common stock, 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's business strategy has been revised to include the issuance of its securities to acquire companies or assets. DOR BioPharma presently is involved in 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.