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DOR Enters Into Letter of Intent With IDIS for Named Patient Access of orBec(R) in Europe
EWING, NJ, USA | May 22, 2008 | DOR BioPharma, Inc. (OTCBB: DORB) ("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gastrointestinal diseases and vaccines against certain bioterrorism agents, announced today that it has voluntarily withdrawn its European Marketing Authorization Application (MAA) for its investigational drug orBec(R) (oral beclomethasone dipropionate) for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD).
DOR reached this decision after consultation with the European Medicines Evaluation Agency (EMEA) and is based on the assessment that confirmatory evidence of clinical efficacy will be required for approval, which is consistent with the request made by the US Food and Drug Administration (FDA) in their October 18, 2007 non-approvable letter. The withdrawal of an MAA application does not prejudice the possibility of DOR making a new application at a later stage.
As part of DOR's ongoing European regulatory and development strategy, DOR has entered into a letter of intent for a Named Patient Program (NPP) for orBec(R) for the treatment of GI GVHD with IDIS, worldwide specialists in the management of NPPs. The NPP will allow DOR to ensure that patients with GI GVHD, an unmet medical need, can access orBec(R) legally and ethically.
"After carefully evaluating the EMEA's assessment of our MAA, we believe that withdrawal of the MAA is appropriate at this time," stated Christopher J. Schaber, PhD, President and CEO of DOR BioPharma. "Given the FDA request for an additional clinical trial, we knew that the need for additional clinical data by the EMEA was a reasonable possibility. However, we remain confident in the pharmacology of orBec(R) and the clinical data that we have in hand from the two randomized, double-blind, placebo-controlled studies. We anticipate meeting with the EMEA to review the design of our upcoming confirmatory Phase 3 clinical trial. In the meantime, our mission remains unchanged, to deliver orBec(R) to patients who desperately need this therapeutic option throughout the world. With this focus in mind, we are extremely pleased to have entered into a letter of intent with IDIS, a well regarded and experienced company, to implement our NPP in Europe. We anticipate being able to potentially generate meaningful revenues for orBec(R) in Europe through the NPP during the conduct of the Phase 3 clinical trial.
"We are delighted to be working with DOR BioPharma to ensure that GI GVHD patients with an urgent unmet medical need have access to orBec(R) and can benefit from DOR BioPharma's innovative therapy," said John Lagus, Vice President of Business Development for IDIS. "IDIS will work in close partnership with DOR BioPharma to manage NPP requests in a way that is reliable, responsible and legal, ensuring 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 the life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec(R) (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(R) 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(R). orBec(R) 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 also 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.
SOURCE: DOR BioPharma, Inc. |
