EWING, NJ -- (Marketwire) -- 12/01/08 -- DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the
"Company") announced today that it has received $1.5 million under a 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 or oral BDP) and potentially other DOR
pipeline compounds until March 1, 2009.
Under the terms of the letter of intent, Sigma-Tau has purchased $1.5
million of DOR's common stock at the market price of $0.09 per share, which
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.
Gregg Lapointe, Chief Executive Officer of Sigma-Tau, commented, "As a
result of our long-standing relationship with DOR, we are confident
orBec® will prove successful in the confirmatory Phase 3 clinical
program. orBec® is also a very good fit with our rare disease focus,
particularly with our other development activities in the transplant area.
We look forward to finalizing our collaboration with DOR in the
progression of this important compound."
"We are very pleased with Sigma-Tau's interest in orBec®," said
Christopher J. Schaber, PhD, President and CEO of DOR. "We have known
Sigma-Tau for a long time and have observed their strong commitment in
working with other biotech companies, and have confidence in their
expertise in commercializing orphan products. We look forward to
productive discussions with Sigma-Tau to reach a mutually beneficial
collaboration."
The common stock sold to Sigma-Tau has not been registered under the
Securities Act of 1933 (the "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 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 GVHD, the organ system where GVHD is most
frequently encountered and highly problematic. 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 US 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 distal portions of the GI tract.
Two prior randomized, double-blind, placebo-controlled Phase 2 and 3
clinical trials demonstrated that orBec® provides clinically meaningful
outcomes when compared with the current standard of care, including a
lowered exposure to systemic corticosteroids following allogeneic
transplantation. Currently, there are no approved products to treat GI
GVHD. The Phase 3 trial was a 129-patient pivotal Phase 3 multi-center
clinical trial of orBec® conducted at 16 leading bone marrow/stem cell
transplantation centers in the US and France.
