DOR BioPharma Plans FDA NDA and European MAA Filing Strategy for orBec

DOR BioPharma, Inc. (AMEX:DOR) ("DOR" or the "Company"),
announced today that following written communications and meetings
with the FDA and with the comparable regulatory authorities of the
German, French and UK governments, it has established an expanded
strategy for the submission of a New Drug Application (NDA) and
Marketing Authorization Application (MAA) for orBec(R) for the
treatment of intestinal Graft-versus-Host disease ("iGVHD").
   Following a meeting on November 1, 2005 with the Division of Drug
Oncology Products at the FDA, DOR intends to submit the NDA for
orBec(R) in the United States in early 2006. On November 3rd, 4th and
7th, DOR met with the Bundesinstitut fur Arzneimittel und
Medizinprodukte (BfArM) in Germany, the Agence Francaise de Securite
Sanitaire des Produits de Sante (AFSSaPS) in France, and the Medicines
and Healthcare products Regulatory Agency (MHRA) in the UK
respectively. Based on these meetings, which followed submission of a
pre-meeting package, DOR has determined to submit an MAA to the
centralized European Agency for the Evaluation of Medicinal Products
(EMEA) in the first half of 2006.
   Michael T. Sember, President and CEO of DOR commented, "This was
our first meeting with the Oncology Division following the transfer of
reviewing responsibility from the Gastrointestinal Division. The
meeting was very productive and provided DOR with valuable advice,
particularly with regard to the Division's current weighting of the
net clinical benefit of a product addressing an unmet medical
condition such as iGVHD. The Division has informed us that the
mortality results of the pivotal trial are of particular importance
for their review of the NDA and they have asked for additional
mortality information which we will provide. We were also very pleased
with the cooperation and helpful advice of the European authorities
and have thus decided to move ahead with the MAA filing ahead of our
previous plans."
   In conjunction with our plans for submission of the MAA in Europe,
we have increased our commercial activities in Europe and are now in
discussions with a number of parties regarding a potential licensing
arrangement.

   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 GI disorders
characterized by severe inflammation. We plan to file a new drug
application (NDA) with the FDA for orBec(R) for the treatment of iGVHD
in early 2006.
   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 ("AMEX") by completing a transaction which
will provide it with shareholders' equity of at least $6 million prior
to a date set by AMEX for a hearing regarding the continued listing on
AMEX of DOR BioPharma's common stock, 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.