SOURCE: DOR BioPharma, Inc.

September 10, 2008 07:00 ET

DOR BioPharma Announces Named Patient Access Program for Latin America in Collaboration With BurnsAdler

orBec® Positioned to Be Available Under Named Patient Programs in Over 50 Countries Worldwide

EWING, NJ--(Marketwire - September 10, 2008) - DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company"), a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines against certain bioterrorism agents, announced today that it has entered into a collaboration with BurnsAdler Pharmaceuticals, Inc. (BurnsAdler), a specialty pharmaceutical company based in North Carolina under which BurnsAdler will act as DOR's distributor of a Named Patient Access Program (NPAP) for orBec® to patients suffering from acute gastrointestinal Graft-versus-Host disease (GI GVHD) in all countries within Central America, South America and the Caribbean ("Latin America").

The NPAP is a compassionate use drug supply program under which medical practitioners can legally supply investigational drugs to their eligible patients. Under this program, investigational drugs can be administered to patients who are suffering from serious illnesses until the drug is approved by the regional regulatory authorities. BurnsAdler and DOR will share revenues generated by sales of orBec® through the NPAP. DOR will manufacture and supply orBec® to BurnsAdler, while BurnsAdler will be responsible for all distribution costs in the Territory.

"We are very pleased to be working with DOR on the NPAP for orBec®," said Bryan Somerville, President of BurnsAdler. "There is an acute need for a new drug to treat GI GVHD as a result of hematopoietic stem cell transplantation in Latin America. Given the impressive pharmacology orBec® has shown as well as the fact that it is the first directed therapy for patients suffering from GI GVHD, we are glad to be able to make this innovative drug available to patients in Latin America."

"We are pleased to be able to work with BurnsAdler to administer this important program," stated Christopher J. Schaber, PhD, President and CEO of DOR. "We have great confidence in BurnsAdler and their ability to manage the NPAP in Latin America."

Dr. Schaber continued, "We now have the potential to have named patient access programs in over 50 countries worldwide. While we work to complete orBec®'s clinical development, we are continuing our worldwide strategy of generating revenues to support ongoing development programs while making this important therapy available now to patients suffering from acute GI GVHD wherever possible."

DOR's Named Patient Programs Partners for orBec®

DOR Named Patient Access Partner                      Territory

BL&H                                      South Korea
BurnsAdler                                Mexico, Central and South America
                                          and the Caribbean
IDIS                                      European Union
Orphan Australia                          Australia, New Zealand and
                                          South Africa
Pacific Healthcare                        Brunei, Cambodia, Indonesia,
                                          Laos, Myanmar, Philippines,
                                          Thailand and Vietnam
Steward Cross                             Singapore and Malaysia

About BurnsAdler Pharmaceuticals, Inc.

BurnsAdler Pharmaceuticals, Inc., a portfolio company of Bourne Capital Partners, LLC, is a specialty pharmaceutical company that promotes, sells and distributes products throughout Latin America, including Mexico, Puerto Rico and the Caribbean. Through relationships with product developers from the Unites States and Europe, BurnsAdler helps deliver world-class medicine to these challenging international markets. BurnsAdler's portfolio strategy focuses on pharmaceutical products and medical devices used in oncology, gastroenterology, cardiovascular medicine, orthopedic medicine, hospitals and other critical care settings.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. (DOR) is a late-stage 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 or BDP), is a potent, locally acting corticosteroid being developed for the treatment of gastrointestinal Graft-versus-Host disease (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 received a not approvable letter in which the FDA has requested data from a confirmatory Phase 3 clinical trial to demonstrate the safety and efficacy of orBec®. orBec® is currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation. Additionally, DOR has a Lipid Polymer Micelle (LPM™) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

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, botulinum toxin and anthrax. 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, Inc., please visit the Company's website located at 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, 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 secure partnerships or obtain financing within the next nine months to meet operating expenses and to conduct its upcoming confirmatory Phase 3 trial of orBec®, 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.

Contact Information

  • Company Contact:

    Evan Myrianthopoulos
    Chief Financial Officer
    (609) 538-8200
    www.dorbiopharma.com

    DOR BioPharma, Inc.
    850 Bear Tavern Road, Suite 201
    Ewing, NJ 08628