DOR BioPharma Provides Regulatory Update on orBec.MIAMI Miami, cities, United States Miami (mīăm`ē, –ə). 1 City (1990 pop. 358,548), seat of Dade co., SE Fla., on Biscayne Bay at the mouth of the Miami River; inc. 1896. -- Reissuing release to correct ticker symbol for searching purposes. The corrected release reads: DOR BIOPHARMA PROVIDES REGULATORY UPDATE ON ORBEC DOR BioPharma, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :DORB DORB Data Object Request Broker ) ("DOR", or the "Company") announced today that it is providing new guidance on the filing of its New Drug Application ("NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ") and Marketing Authorization Application ("MAA MAA abbr. macroaggregated albumin ") submissions for orBec(R) for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD GVHD graft-versus-host-disease. GVHD Graft-versus-host disease, see there ). DOR's target for submission of the NDA for orBec(R) is now in the July - August timeframe of 2006. DOR's filing target in the EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. remains by the end of the 3rd Quarter 2006. Earlier this month, the Company conducted pre-submission meetings with the EMEA assigned rapporteur rap·por·teur n. One who is designated to give a report, as at a meeting. [Middle English raportour, judge, from Old French raporteur, from raporter, to bring back and co-rapporteur countries, namely the MPA MPA medroxyprogesterone acetate. (Medical Products Agency) of Sweden and the Spanish AEMPS AEMPS Agencia Española de Medicamentos y Productos Sanitarios (Spanish) (Agencia Espanola del Medicamento and Productos Sanitarios). The meetings were productive, and provided guidance and feedback from the agencies regarding the submission of the orBec MAA in the European Union. The Company will continue to work closely with the EMEA during the next quarter as it prepares its MAA filing. Michael Sember, President and Chief Executive Officer of DOR commented, "We are very near the end of our NDA assembly and filing program. The delay is due to the complexity and sheer size of the filing process. We remain highly enthusiastic about orBec(R) and its prospects and we are working diligently to file both the NDA and the MAA as soon as possible. Once filed, the NDA will contain additional information specifically requested by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. with regard to survival results in a Phase II study of oral beclomethasone (BDP BDP Botswana Democratic Party BDP Bund Der Pfadfinderinnen und Pfadfinder (German Scouts) BDP Boogie Down Productions BDP Bandwidth Delay Product BDP Beclomethasone Dipropionate BDP Business Development Program ) and our pivotal Phase III orBec(R) study. We have now added positive survival data in support of oral BDP at 200 days post transplant in the Phase II study, and 1 year post randomization randomization (ranˈ·d When approved, we expect that orBec(R) will be indicated for the treatment of GI GVHD associated with allogeneic allogeneic /al·lo·ge·ne·ic/ (-je-ne´ik) 1. having cell types that are antigenically distinct. 2. in transplantation biology, denoting individuals (or tissues) that are of the same species but antigenically bone marrow or stem cell transplant (BMT/SCT) procedures. Based on available statistics we estimate that there are approximately 12,000 such procedures annually in the U.S., and a comparable number in Europe. Estimates as to the annual rate of increase in these procedures vary between 2% and 20%. High rates of morbidity and mortality Morbidity and Mortality can refer to:
BMT/SCT is a very costly procedure and requires an intensive use of healthcare resources. Transplant centers are usually reimbursed at a fixed rate of approximately $250,000 per procedure and this is intended to cover all patient follow-up care. Re-hospitalization of these patients places a significant strain on the financial resources of these hospitals. For example, it is estimated that a single re-admission of these patients can cost the institution between $14,000 and $50,000. Under current standard of care, patients have a high rate of re-admission due to relapse of GI GVHD or leukemia. If patients become terminal and enter critical care, the costs mount quickly. In two separate randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blinded, placebo-controlled trials in GI GVHD, oral BDP and orBec(R) have shown approximately 55% and 67% reductions in mortality at 200 days post transplant. About DOR BioPharma, Inc. DOR BioPharma, Inc. is a biopharmaceutical company addressing life-threatening side effects of cancer and cancer treatments, serious gastrointestinal diseases and disorders, and biomedical countermeasures. Our 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 serious complication of bone marrow transplantation Bone Marrow Transplantation Definition The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets. for cancer, as well as other gastrointestinal disorders characterized by severe inflammation. We plan to file a new drug application (NDA) with the FDA for orBec(R) for the treatment of GI GVHD in the July - August timeframe of 2006. Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the paradigm established by the recently enacted Project BioShield Act The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for the donation of over $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. of 2004. Our biodefense products in development are bioengineered vaccines designed to protect against the deadly effects of ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine, RiVax(TM), has successfully completed a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in normal volunteers. We have also initiated a botulinum toxin therapeutic development program based on rational drug design. For further information regarding DOR BioPharma, please visit the Company's website located at http://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's current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec(R) for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBec(R). Where possible, DOR BioPharma 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 BioPharma cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec(R), 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 U.S. Government or other countries, 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(R) for gastrointestinal GVHD include the risks that: because orBec(R) did not achieve statistical significance in its primary endpoint in the pivotal Phase III clinical study (i.e. a p-value of less than or equal to 0.05), the FDA may not consider orBec(R) approvable based upon existing studies, orBec(R) may not show therapeutic effect or an acceptable safety profile in future clinical trials, if required, or could take a significantly longer time to gain regulatory approval than DOR BioPharma expects or may never gain approval; DOR BioPharma 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; or orBec(R) may not gain market acceptance; and others may develop technologies or products superior to orBec(R). These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR BioPharma's most recent reports on Form 10-QSB and Form 10-KSB. DOR BioPharma 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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