DOR BioPharma Plans FDA NDA and European MAA Filing Strategy for orBec
November 15 2005 - 9:04AM
Business Wire
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.
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