DOR BioPharma Enters Into Collaborative Agreement With IDIS for Named Patient Access of orBec(R) in Europe
Tuesday July 15, 8:35 am ET
EWING, NJ--(MARKET WIRE)--Jul 15, 2008 -- DOR BioPharma, Inc. (OTC BB:DORB.OB - News) ("DOR" or the "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 www.idispharma.com.
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(TM)) 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 |
