DOR BioPharma, Inc. Has Voluntarily Withdrawn European Marketing Authorization Application (MAA) For Orbec(R) For The Treatment Of Gastrointestinal Graft-Versus-Host Disease (GI GVHD)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® 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® 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® 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® 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® 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® 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® (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 also 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.
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.
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Source: DOR BioPharma, Inc.