DOR BioPharma Granted SME Status by the European Commission and the EMEA.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. -- DOR Dor or Dora, Canaanite seaport, ancient Palestine (modern Israel), N of Caesarea Palestinae. It was never a Jewish city but rather a Phoenician outpost. It was rebuilt by the Romans; still visible are the ruins of a temple and a theater. BioPharma, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :DORB DORB Data Object Request Broker ) ("DOR" or the "Company"), announced today that the European Commission and the centralized European Agency for the Evaluation of Medicinal Products (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. ) has granted DOR incentives for Small and Medium Sized Enterprises (SME (1) (Small and Medium-sized Enterprise) See SMB. (2) (Subject Matter Expert) An individual who is well-versed in the policies and procedures of a particular department or division. ). The SME program is a new initiative by the EMEA that is dedicated to addressing the particular needs of small and medium size companies developing medicinal products in Europe. Companies that are granted SME status are able to seek assistance, information and training from dedicated EMEA personnel, particularly for Marketing Authorization Applications (MAA MAA abbr. macroaggregated albumin ). In addition, SME status may accord companies reduced or deferred fees associated with marketing authorization applications, scientific advice and inspections. Restricted to companies based in the European Union, SME status has been granted to DOR despite the company being based in the United States because Voisin Consulting, a regulatory consulting SME firm with headquarters in France, is representing the Company in Europe. "We are very pleased to be one of the first US companies to benefit from the incentives granted by the SME initiative in Europe," commented Michael T. Sember, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of DOR. "SME status represents important economic incentives for a small company such as DOR. The SME status will facilitate the filing process to obtain the ultimate approval of orBec(R) in the European Union. We are particularly gratified grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. to be among the first US companies to receive this designation. Our plan is to submit an 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 in the US this quarter and subsequently the MAA." About Voisin Consulting Voisin Consulting is a regulatory consulting firm headquartered in France, Paris and Rennes, with offices in Lausanne, Switzerland, and Melbourne, Australia. Voisin has been advising and assisting DOR with the preparation of the MAA in Europe for orBec(R) (oral beclomethasone dipropionate), to be submitted for the treatment of gastrointestinal Graft-versus-Host disease (GVHD GVHD graft-versus-host-disease. GVHD Graft-versus-host disease, see there ). DOR and Voisin Consulting received an SME number that can be used for the activities of DOR in Europe when performed in collaboration with Voisin Consulting. Voisin Consulting SME status can be used to assist other non European Union SMEs. 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 bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. countermeasures. Our lead product, orBec(R) (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and being developed for the treatment of gastrointestinal Graft-versus-Host disease (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 GI disorders characterized by severe inflammation. We plan to file a new drug application (NDA) with 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. for orBec(R) for the treatment of gastrointestinal GVHD in the second quarter 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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