2008-07-15 07:36:00
DOR BioPharma Enters Into Collaborative Agreement With IDIS for Named Patient Access of orBec® in Europe
EWING, NJ–(EMWNews – July 15, 2008) – DOR BioPharma, Inc. (
“Company”), a late-stage biopharmaceutical company developing products to
treat the life-threatening side effects of cancer treatments, serious
gastrointestinal diseases and vaccines against certain bioterrorism agents,
announced today that it has executed a definitive collaborative agreement
with IDIS Limited (“IDIS”), for the supply and distribution within the
European Union of the Company’s investigational drug orBec® (oral
beclomethasone dipropionate) for the treatment of gastrointestinal
Graft-versus-Host disease (“GI GVHD”) via a named patient program (“NPP”).
IDIS is the leading specialist in the management of NPPs in Europe. An NPP
is a compassionate use drug supply program under which medical
practitioners can legally supply investigational drugs to qualifying
patients. Under an NPP, investigational drugs can be administered to
patients who are suffering from serious illnesses until the drug is
approved by the European Medicines Evaluation Agency (“EMEA”) or a national
health authority. The NPP will allow DOR to provide a treatment option to
patients with GI GVHD, an unmet medical need. The GI GVHD market in Europe
is believed to be about 60% of the more than 10,000 allogeneic bone
marrow/stem cell transplantations occurring there annually.
“We are very pleased to partner with IDIS to make orBec® available to GI
GVHD patients in Europe,” stated Christopher J. Schaber, PhD, President and
CEO of DOR BioPharma. “We remain steadfast in our mission to deliver
orBec® to patients who desperately need a therapeutic option. Based on
its reach and focus, IDIS is clearly the optimal choice as a partner for
implementing the NPP in Europe. We anticipate initiating this program soon
knowing there is potential to generate revenues that will help to support
the confirmatory orBec® Phase 3 clinical trial. We have already received
inquiries from clinicians in Europe interested in the availability of
orBec® for their patients.”
“We are delighted to be working with DOR to provide patients with GI GVHD
access to orBec®, so they can benefit from DOR’s innovative therapy,”
said John Lagus, Vice President of Business Development for IDIS. “IDIS
will work in close partnership with DOR to manage NPP requests in a way
that is reliable and responsible while ensuring that all the regulatory
obligations are met.”
About IDIS
IDIS is the world leader in the development and implementation of Named
Patient Programs and has a proven track record of working in strategic
partnership with US-based companies to bring new medicines to Europe for
the first time. IDIS supports its customers in over 100 countries
worldwide, supplying more than 400 different medicines per month and
responding to more than half a million requests on a named-patient basis to
medical professionals worldwide. Headquartered near central London, IDIS
has been a strategic partner to more than 40 pharmaceutical and biotech
companies. For more information on IDIS, please visit the website
About DOR BioPharma, Inc.
DOR BioPharma, Inc. (DOR) is a late-stage 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 or BDP), is a potent, locally acting corticosteroid being
developed for the treatment of gastrointestinal Graft-versus-Host disease
(GI GVHD), a common and potentially life-threatening complication of bone
marrow transplantation. DOR filed a New Drug Application for orBec® with
the FDA for the treatment of acute GI GVHD and received a not approvable
letter in which the FDA has requested data from a confirmatory Phase 3
clinical trial to demonstrate the safety and efficacy of orBec®.
orBec® is currently the subject of an NIH-supported, Phase 2, randomized,
double-blind, placebo-controlled trial in the prevention of acute GVHD.
Oral BDP may also have application in treating other gastrointestinal
disorders characterized by severe inflammation. DOR has initiated a
development program with its Lipid Polymer Micelle (LPM™) drug delivery
technology for the oral delivery of leuprolide for the treatment of
prostate cancer and endometriosis.
Through its Biodefense Division, DOR is developing biomedical
countermeasures pursuant to the 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,
botulinum toxin and anthrax. DOR’s ricin toxin vaccine, RiVax, has been
shown to be well tolerated and immunogenic in a Phase 1 clinical trial in
normal volunteers.
For further information regarding DOR BioPharma, Inc., please visit the
Company’s website located at 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, 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 US Government or other
countries, enter into a definitive agreement with IDIS for a NPAP for
orBec® for the treatment of GI GVHD, that the US 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: the FDA’s requirement that DOR conduct additional clinical trials to
demonstrate the safety and efficacy of orBec® will take a significant
amount of time and money to complete and positive results leading to
regulatory approval cannot be assumed; 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; orBec® may not gain market acceptance if it is eventually
approved by the FDA; 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.
Company Contact: Evan Myrianthopoulos Chief Financial Officer (609) 538-8200 www.dorbiopharma.com |
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