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DOR BioPharma Announces Named Patient Access Program for orBec(R) in Thailand and Other ASEAN Countries in Collaboration With Pacific Healthcare EWING, NJ--(MARKET WIRE)--Aug 27, 2008 -- DOR BioPharma, Inc. (OTC BB:DORB.OB - News) ("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
Pacific Healthcare Thailand Co., Ltd. (Pacific), a specialty
pharmaceutical
company based in Bangkok, under which Pacific will act as
DOR's Sponsor to
administer a Named Patient Access Program (NPAP) for orBec®
to patients
suffering from acute gastrointestinal Graft-versus-Host
disease (GI GVHD)
in Thailand as well as other Association of Southeast Asian
Nations (ASEAN)
member countries including Brunei, Cambodia, Indonesia,
Laos, Myanmar,
Philippines and Vietnam (the Territory).
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 various regional regulatory authorities. Pacific and DOR will share revenues generated by sales of orBec® through the NPAP. DOR will manufacture and supply orBec® to Pacific, while Pacific will be responsible for all distribution costs in the Territory. "As a Board member and the largest shareholder of DOR, I am well acquainted with orBec®'s pharmacology, compelling clinical data and its demonstrated ability to help GI GVHD patients," said Cyrille F. Buhrman, Chairman and Chief Executive Officer of Pacific Healthcare Group. "We are very pleased to be able to make this innovative treatment for acute GI GVHD available through the NPAP to our Thai and other ASEAN member nation patients." "We are pleased to be able to work with our Board member Cyrille Buhrman and Pacific Healthcare to administer this important program," stated Christopher J. Schaber, PhD, President and CEO of DOR. "We are very familiar with Pacific Healthcare and have great confidence in their ability to manage the NPAP in Thailand and their other Territories. We have now established named patient access programs in Europe, Australia, New Zealand, South Korea, South Africa and all of the 10 ASEAN member nations. While we work to complete orBec®'s clinical development, we are continuing our worldwide strategy of making this important therapy available to patients suffering from acute GI GVHD wherever possible." About orBec® Named Patient Programs DOR is working with its partners to make orBec® available worldwide via Named Patient Access Programs (NPAPs) for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of bone marrow transplantation. The NPAP is a compassionate use drug supply program under which medical practitioners can legally supply investigational drugs to their patients who qualify. Under this program, investigational drugs can be administered to patients who are suffering from serious illnesses until the drug is approved.
DOR Named Patient Access Partner Territory
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IDIS European Union
BL&H Co. South Korea
Pacific Healthcare Co. Brunei, Cambodia, Indonesia, Laos,
Myanmar, Philippines, Thailand and
Vietnam
Steward Cross Singapore and Malaysia
Orphan Australia Australia, New Zealand and South AfricaAbout Pacific Healthcare Thailand Co., Ltd. Pacific Healthcare Group was established in 1961 and is currently one of the leading importers and distributors of healthcare products in Thailand and the Philippines. According to the IMS, Pacific Healthcare Thailand is one of the fastest growing distributors for four consecutive years. Pacific Healthcare Group has more than 350 full-time employees, 85 percent of whom are in sales and marketing operations. Its main activities can be divided into four categories offering a full range of marketing, sales services, warehouse and physical distribution, import and custom clearance and product registration: pharmaceuticals, medical device and consumer health. Pacific has been trusted by more than 30 global principals including: Ansell, Asence, Balt, Bausch & Lomb, Bioniche, Chiesi, Dairy Goat Cooperatives, DSM, Ferrer, Ferring, Frieslandfoods, Echosens, Grifols, Guerbet, Healtheries, Italfarmaco, Ipsen, Ipca, JMS, Kimberly Clark Healthcare, Medinova, Minntech, Nasaleze, Nordmark, Nutrition21, Pierre Fabre, Terumo, TEVA, and more. Its distribution network covers the entire geography of Thailand and countries in Southeast Asia, and specializes in the following channels: hospitals, clinics, pharmacies (OTC) and modern trade and is also certified for wholesale and distribution GMP. 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(TM)) 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(TM), 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: Company Contact:
Evan Myrianthopoulos
Chief Financial Officer
(609) 538-8200
http://www.dorbiopharma.com
DOR BioPharma, Inc.
850 Bear Tavern Road, Suite 201
Ewing, NJ 08628
Source: DOR BioPharma, Inc.
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