DOR BioPharma Enters Into Collaborative Agreement With IDIS for Named Patient Access of orBec(R) in Europe

SOURCE:

DOR BioPharma, Inc.

2008-07-15 07:36:00

DOR BioPharma Enters Into Collaborative Agreement With IDIS for Named Patient Access of orBec® in Europe

EWING, NJ–(EMWNews – July 15, 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, serious

gastrointestinal diseases and vaccines against certain bioterrorism agents,

announced today that it has executed a definitive collaborative agreement

with IDIS Limited (“IDIS”), for the supply and distribution within the

European Union of the Company’s investigational drug orBec® (oral

beclomethasone dipropionate) for the treatment of gastrointestinal

Graft-versus-Host disease (“GI GVHD”) via a named patient program (“NPP”).

IDIS is the leading specialist in the management of NPPs in Europe. An NPP

is a compassionate use drug supply program under which medical

practitioners can legally supply investigational drugs to qualifying

patients. Under an NPP, investigational drugs can be administered to

patients who are suffering from serious illnesses until the drug is

approved by the European Medicines Evaluation Agency (“EMEA”) or a national

health authority. The NPP will allow DOR to provide a treatment option to

patients with GI GVHD, an unmet medical need. The GI GVHD market in Europe

is believed to be about 60% of the more than 10,000 allogeneic bone

marrow/stem cell transplantations occurring there annually.

“We are very pleased to partner with IDIS to make orBec® available to GI

GVHD patients in Europe,” stated Christopher J. Schaber, PhD, President and

CEO of DOR BioPharma. “We remain steadfast in our mission to deliver

orBec® to patients who desperately need a therapeutic option. Based on

its reach and focus, IDIS is clearly the optimal choice as a partner for

implementing the NPP in Europe. We anticipate initiating this program soon

knowing there is potential to generate revenues that will help to support

the confirmatory orBec® Phase 3 clinical trial. We have already received

inquiries from clinicians in Europe interested in the availability of

orBec® for their patients.”

“We are delighted to be working with DOR to provide patients with GI GVHD

access to orBec®, so they can benefit from DOR’s innovative therapy,”

said John Lagus, Vice President of Business Development for IDIS. “IDIS

will work in close partnership with DOR to manage NPP requests in a way

that is reliable and responsible while ensuring that all the regulatory

obligations are met.”

About IDIS

IDIS is the world leader in the development and implementation of Named

Patient Programs and has a proven track record of working in strategic

partnership with US-based companies to bring new medicines to Europe for

the first time. IDIS supports its customers in over 100 countries

worldwide, supplying more than 400 different medicines per month and

responding to more than half a million requests on a named-patient basis to

medical professionals worldwide. Headquartered near central London, IDIS

has been a strategic partner to more than 40 pharmaceutical and biotech

companies. For more information on IDIS, please visit the website

www.idispharma.com.

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. DOR has initiated a

development program with its 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 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, enter into a definitive agreement with IDIS for a NPAP for

orBec® for the treatment of GI GVHD, 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.

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

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