Dor (AMEX:DOR)
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DOR BioPharma, Inc. (AMEX:DOR) ("DOR", or the "Company")
announced today that it is focusing its resources on the preparation
of New Drug Application ("NDA") and Marketing Authorization
Application ("MAA") submissions and potential regulatory approvals for
orBec(R) for the treatment of intestinal Graft-versus-Host disease
("iGVHD"). The Company is also providing guidance regarding its
projected rate of cash expenditures for 2006. The Company believes it
can achieve its current strategic goals for the year with average
quarterly cash expenditures of approximately $800,000, or about
$270,000 per month, although first quarter expenditures will likely be
a little higher.
Following the Company's November 1st 2005 pre-NDA meeting with the
FDA's Oncology drug products division, DOR's target for submission is
by the end of the first quarter of 2006. In addition, the Company is
preparing a regulatory filing for Europe that it expects will be
submitted before the end of the second quarter of 2006. Earlier this
week, the Company had a pre-submission meeting in London with the
EMEA. The meeting was an important procedural one which provided the
Company with authoritative procedural, regulatory and legal advice on
the filing. The Company will continue to work closely with the EMEA in
the coming months as it prepares its MAA filing.
Michael Sember, President and Chief Executive Officer of DOR
commented: "We remain highly enthusiastic about orBec(R) and its
prospects and we are diligently preparing both an NDA and well as an
MAA. Our meeting with the FDA oncology products division on November
1st and the subsequent meetings with the German, French and UK
regulatory authorities were encouraging and instructive. Our goal
continues to be the submission of both high quality dossiers in as
timely a fashion as possible. Additionally, we are taking steps to
broaden the indications for orBec(R) beyond the treatment of iGVHD."
When approved, orBec(R) will be indicated for use in iGVHD
associated with allogeneic bone marrow or stem cell transplant
(BMT/SCT) procedures. Based on the latest statistics available we
estimate there are approximately 12,000 such procedures annually in
the U.S. and a comparable number in Europe. Estimates as to the annual
rate of increase in these procedures vary between 2% and 20%. High
rates of morbidity and mortality occur in this patient population. The
successful treatment of iGVHD represents an important unmet medical
need. The FDA has previously granted orBec(R) both orphan drug
designation and Fast Track Designation. Once the NDA is submitted, DOR
believes orBec(R) may qualify for six month priority review from the
date of filing.
BMT/SCT is a very costly procedure and requires an intensive use
of healthcare resources. Transplant centers are usually reimbursed at
a fixed rate of approximately $250,000 per procedure and this is
intended to cover all of a patient's follow-up care.
Re-hospitalization of these patients can put a significant strain on
the financial resources of these hospitals. For example, it is
estimated that a single readmission of these patients can cost the
institution between $14,000 and $50,000 and in the case of iGVHD
patients are generally hospitalized while they rely on parenteral
nutrition for sustenance. Under current standard of care, these
patients have a high rate of readmission due to relapse of iGVHD or
leukemia. These factors contribute to the high rate of mortality in
iGVHD patients and if the patients become terminal and enter critical
care, the costs mount quickly. In two separate randomized,
double-blinded, placebo-controlled trials in iGVHD, orBec(R) has shown
an approximately 70% reduction in mortality as well as a significant
reduction iGVHD relapse rates in the pivotal trial.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company addressing
life-threatening side effects of cancer and cancer treatments, serious
gastrointestinal diseases and disorders, and biomedical
countermeasures. 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 the first quarter of
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, 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 presently is involved in financing 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.