SOURCE: DOR BioPharma, Inc.

November 28, 2007 07:30 ET

DOR BioPharma Announces Named Patient Access Program for orBec® in Collaboration With Orphan Australia Pty Ltd.

DOR Announces Issuance of Australian Patent for orBec®

EWING, NJ--(Marketwire - November 28, 2007) - DOR BioPharma, Inc., (OTCBB: DORB) ("DOR" or the "Company") announced today that it has entered into a Letter of Intent with Orphan Australia Pty Ltd. (Orphan Australia), a specialty pharmaceutical company based in Melbourne, Australia, pursuant to which Orphan Australia will act as DOR's Sponsor with regard to the administration of a Named Patient Access Program (NPAP) for orBec® to gastrointestinal Graft-versus-Host disease (GI GVHD) patients in Australia, New Zealand and South Africa.

The NPAP is a compassionate use drug supply program administered by the Therapeutic Goods Administration (TGA), under which medical practitioners can legally supply investigational drugs to their patients who qualify. The program enables a medical practitioner to access not yet approved medicines for seriously ill patients with prior notification to the TGA. Both Orphan Australia, acting as Sponsor for the program, and DOR will receive revenue for supplying orBec® under the NPAP. New Zealand and South Africa also have similar access mechanisms for supply under a "Named Patient" basis.

"The results of orBec®'s clinical trials that have recently been published in key peer reviewed journals have caught the attention of many bone marrow/stem cell transplantation specialists here in Australia," said John Michailidis, Chief Executive Officer of Orphan Australia. "Given the continuing need of their patients suffering from GI GVHD, these key opinion leaders have expressed a desire to promptly access orBec® to treat their patients. We are pleased to be able to gain access to this important drug for our clinicians and their transplant patients through the Named Patient Access Program."

Christopher J. Schaber, PhD, President and CEO of DOR BioPharma, stated, "We are very pleased to be working with Orphan Australia to make orBec® available to patients through the Named Patient Access Program. As we have stated before, our strategy is to develop orBec® as rapidly as possible so that the patients who need it will have access to it as soon as possible. We plan on moving forward to complete the clinical development of orBec® in as short a timeframe as possible. We will concurrently pursue similar types of programs in the United States, European Union, and the rest of the world so that GI GVHD patients will have this important treatment option."

DOR also announced today that the Australian Patent Office has granted the issuance of patent # 2002254205, entitled "Method of treating inflammatory conditions of the gastrointestinal tract using topically active corticosteroids." The patent claims cover the use of orBec® (oral beclomethasone) as well as other topically active corticosteroids to treat various inflammatory bowel diseases including GI GVHD.

About Orphan Australia Pty Ltd.

Orphan Australia is a privately owned pharmaceutical company based in Melbourne, providing hospital specialist products to Australia, New Zealand and recently commenced operations in selected South East Asian countries. Orphan Australia specializes in bringing to market novel compounds that treat serious or life-threatening diseases where treatment choices are limited or inadequate.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. (DOR) is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of bone marrow transplantation. DOR filed a New Drug Application for orBec® with the FDA for the treatment of acute GI GVHD and has recently received a not approvable letter in which the FDA has requested data from additional clinical trials to demonstrate the safety and efficacy of orBec®. A Marketing Authorization Application with the European Medicines Evaluation Agency has also been validated and is under review. orBec® is currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. orBec® may also have application in treating other gastrointestinal disorders characterized by severe inflammation. DOR has recently initiated a development program with its Lipid Polymer Micelle (LPM™) oral drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis, as well as a development program with its oral azathioprine technology for the treatment of oral GVHD.

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. DOR's ricin toxin vaccine, RiVax™, has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.

For further information regarding DOR BioPharma, please visit the Company's website located at

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec® for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBec®. Where possible, DOR 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 cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, 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 US Government or other countries, that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program, 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, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the risks that: the FDA's requirement that DOR conduct additional clinical trials to demonstrate the safety and efficacy of orBec® will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; DOR 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; orBec® may not gain market acceptance if it is eventually approved by the FDA; and others may develop technologies or products superior to orBec®. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Form 10-QSB and Form 10-KSB. DOR 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.