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January
4 ,
2007 DOR
BioPharma Receives $3 Million from Sigma-Tau Pharmaceuticals
for Exclusive Right to Negotiate orBec® Strategic
Alliance.
Miami,
FL. – January 4, 2007 - DOR BioPharma, Inc.
(OTCBB: DORB) (“DOR” or the “Company”)
announced today that it has received $3 million
under a non-binding letter of intent with Sigma-Tau
Pharmaceuticals, Inc. (“Sigma-Tau”),
which grants Sigma-Tau an exclusive right to negotiate
terms and conditions for a possible business transaction
or strategic alliance regarding orBec® (oral
beclomethasone dipropionate) and potentially other
DOR pipeline compounds until March 1, 2007.
Under
the terms of the agreement, Sigma-Tau has purchased
$1 million of DOR’s common stock at the market
price of $0.246 per share, representing approximately
four million shares. An additional $2 million was
paid in cash, and will be considered an advance
payment to be deducted from upfront monies due to
DOR by Sigma-Tau pursuant to any future orBec commercialization
arrangement reached between the two parties. If
no agreement is reached by March 1, 2007, DOR will
return the $2 million to Sigma-Tau within 60 days.
If DOR does not pay Sigma Tau back in cash by May
31, 2007, interest will accrue at a rate of 6% compounded
annually and Sigma Tau will have the option in its
sole discretion of converting the accrued amount
into common stock at a price per share equal to
80% of the market price at the time the payment
is made.
“We
are exceptionally pleased with Sigma-Tau’s
interest in orBec® and in DOR’s pipeline
products,” said Christopher J. Schaber, Ph.D.,
President and CEO of DOR. “We view Sigma-Tau
as an excellent potential partner for orBec®
especially with regard to the EU territory. We look
forward to productive discussions with Sigma-Tau
to reach a mutually beneficial arrangement.”
The
common stock sold to Sigma-Tau has not been registered
under the Securities Act or any state securities
laws, and the securities may not be offered or sold
absent registration or an applicable exemption from
the registration requirements of the Securities
Act and applicable state securities laws.
About
orBec®
orBec®
represents a first-of-its-kind oral, locally acting
therapy tailored to treat the gastrointestinal manifestation
of Graft-versus-Host Disease (“GVHD”),
the organ system where GVHD is most frequently encountered
and is highly problematic. orBec®, if approved
by the EMEA and the FDA, would be the first approved
treatment for GI GVHD and the first oral formulation
of beclomethasone dipropionate ("BDP")
available in the European Union and the United States,
respectively. orBec® is intended to reduce the
need for systemic immunosuppressive drugs to treat
GI GVHD. BDP is a highly potent, topically active
corticosteroid that has a local effect on inflamed
tissue. BDP has been marketed in the U.S. and worldwide
since the early 1970s as the active pharmaceutical
ingredient in a nasal spray and in a metered dose
inhaler for the treatment of patients with allergic
rhinitis and asthma. orBec® is formulated for
oral administration as a single product consisting
of two tablets; one tablet is intended to release
BDP in the proximal portions of the GI tract, and
the other tablet is intended to release BDP in the
more distal portions of the GI tract.
About
Sigma-Tau Pharmaceuticals, Inc.
Sigma-Tau
Pharmaceuticals, Inc. is a U.S. based, wholly-owned
subsidiary of the Sigma-Tau Group, and is dedicated
solely to the global development and commercialization
of medicines for patients with rare (“Orphan”)
diseases. Sigma-Tau Pharmaceuticals, Inc. is based
in Gaithersburg, Maryland.
The
Sigma-Tau Group is a privately held, research focused
pharmaceutical company headquartered in Pomezia
(Rome), Italy, with subsidiaries in France, Switzerland,
the Netherlands, Portugal, Germany, Spain, and the
U.S. Employing 2,400 people worldwide (400 in R&D),
the Sigma-Tau Group focuses on several therapeutic
areas, including cardiovascular, metabolism, central
and peripheral nervous system, immunology and oncology,
with a portfolio comprising 48 projects and clinical
trials currently being conducted in 32 different
indications.
About
DOR BioPharma, Inc.
DOR
BioPharma, Inc. is a 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),
is a potent, locally-acting corticosteroid being
developed for the treatment of GI GVHD, a common
and potentially life-threatening complication
of bone marrow transplantation. DOR has filed
an NDA with the FDA for the treatment of GI GVHD,
and has received an FDA PDUFA date of July 21,
2007. An MAA with the EMEA for orBec® has
also been filed and validated. orBec® may
also have application in treating other gastrointestinal
disorders characterized by severe inflammation.
Through its Biodefense Division, DOR is developing
biomedical countermeasures pursuant to the recently
enacted 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 and
botulinum toxin. The ricin toxin vaccine, RiVaxTM,
has been evaluated successfully in a Phase 1 clinical
trial in normal volunteers
For further information regarding DOR BioPharma,
please visit the Company's website located at
www.dorbiopharma.com.
Forward
Looking Statements
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 U.S.
Government or other countries, that the U.S. 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: because orBec®
did not achieve statistical significance in its
primary endpoint in the pivotal Phase 3 clinical
study (i.e. a p-value of less than or equal to 0.05),
the FDA may not consider orBec® approvable based
upon existing studies, orBec® 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
expects or may never gain approval; 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; or orBec® may not gain market
acceptance; 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.
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