DOR Dor Biopharma

DOR BioPharma, Inc. (AMEX:DOR) ("DOR" or the "Company"), today provided a general update on various corporate matters. orBec(R) IND Transferred to FDA's Oncology Division DOR announced today that the IND for its orBec(R) program had been transferred from the FDA's Gastrointestinal Products Division to the Oncology Drug Products Division. From its inception till the present time, the orBec(R) IND has been held and guided by the Gastrointestinal Division. DOR has been and will continue to be in contact with the Oncology Division in the coming weeks to review the orBec(R) program and plan for the NDA filing. In its initial correspondence with DOR about the orBec(R) program, the FDA's Oncology Division had questions and comments about orBec(R) and the transplantation field in general to which DOR has submitted a response. DOR understands that the NDA, when submitted, will be reviewed primarily by the Oncology Drug Products Division with consultation from the Gastrointestinal Division. New orBec(R) Development Grant In other orBec(R) news, DOR has recently received a notice of grant from the FDA's Orphan Products Division for its grant application dated April 6, 2004 entitled "Oral BDP for the Treatment of GI GVHD". The grant totals $318,750 and supports the development of orBec(R) for the treatment of intestinal Graft-versus-Host disease (iGVHD). The proceeds of this grant will be used for data analysis and regulatory work in support of the planned NDA filing. RiVax(TM) Phase I Clinical Trial The clinical portion of DOR's Phase 1 clinical trial of RiVax(TM), its vaccine against ricin toxin, has been completed. DOR will announce the final results of the clinical trial at a later date in deference to its academic partner who will submit the trial results for publication. Michael T. Sember, President and Chief Executive Officer of DOR commented, "2005 has so far been an extremely productive and watershed year in the history of DOR. We have seen substantial progress this year in all three of our programs, and we look forward to the filing of our NDA for orBec(R). We are in contact with AMEX and are working diligently to regain compliance with the AMEX listing standards. As part of our strategy to broaden our oncology and gastrointestinal product pipeline, we are involved in negotiations to acquire novel new products that are synergistic with orBec(R). We are working towards opportunities in the very near term that we expect will increase shareholder value and also allow us to regain and maintain compliance with the continued listing standards." 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 gastrointestinal disorders characterized by severe inflammation. We plan to file a new drug application (NDA) with the FDA for orBec(R) for the treatment of intestinal iGVHD later this year or early next quarter. 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 by regaining compliance by October 15, 2005 or any extension thereto that may or may not be granted, or that it will be able to utilize the AMEX's listing review period (normally up to 52 days within which to have a hearing during which time delisting actions will ordinarily be stayed), 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.