News Details

George A. Robertson, Ph.D. Joins DOR BioPharma as Vice President..

2005/03/11 08:00:35

of Research and Development; BioDefense Expert Will Lead DOR's Botulinum Vaccine and Antidote Programs  MIAMI, Mar 11, 2005 (BUSINESS WIRE) -- DOR BioPharma, Inc. ("DOR" or the "Company") (AMEX:DOR) announced today the appointment of George A. Robertson, Ph.D. as the Company's Vice President of Research and Development. Dr. Robertson brings to DOR over 20 years of experience in the pharmaceutical, biopharmaceutical and biodefense industries, specializing in process development, manufacturing, validation, QA/QC and vaccine technical operations. Dr. Robertson began his pharmaceutical career at Merck, where he was Manager of the Biological Quality Control Laboratories and Biological Production Technical Services Senior Scientist for the introduction of Merck's Hepatitis A vaccine into GMP production.  Dr. Robertson's unique experience includes Director of Quality Control Operations, Wyeth Vaccines where he headed a 120-person Quality Control operation which included pharmaceutical chemical, biochemical, in vivo, microbiological and environmental testing activities. Previously, Dr. Robertson was Program Director for the BioReliance Corporation's 50,000 square foot vaccine manufacturing facility. During his tenure at the NCI-Frederick Cancer Research & Development Center, he contributed to every stage of the design, construction, commissioning and validation of the pilot biologics production program. Under his leadership, the facility produced over twenty new, bio-pharmaceutical products for clinical use.  Dr. Robertson has been a member of the United Nations' biological weapons inspection team in Iraq (1995) and a participant in the U.S. Department of Defense teams searching for biological weapons in the former Soviet Union. He served on the Defense Intelligence Agency Advisory Committee of Experts, evaluating future chemical and biological weapon threats. Retiring in 2000 as a Colonel, Dr. Robertson spent thirty years in special operations and intelligence with the U.S. Army Reserve.  Alexander P. Haig, Chairman of DOR BioPharma commented, "George adds important depth to our team. He has seen the bioweapons threat from all angles and has a unique breadth of experience, both in the military and in the biotech and pharmaceutical industries. We enthusiastically welcome him to our Company."  Following a term as a nationally-elected member of the USP Convention Committee of Revision and of the Bioproducts, Biopolymers and Vaccines Subcommittee, Dr. Robertson now sits on the U.S. Pharmacopeia ad hoc committee to revise Chapter 111 Biological Assays. He also served as a Special Consultant on the National Academy of Sciences, Institute of Medicine Committee to Assess the Safety and Efficacy of the Anthrax Vaccine.  Dr. Robertson earned a Ph.D. in Molecular Biology from the University of Pennsylvania and a post-graduate Business Administration Certificate from the Wharton School. He holds an M.S. in Biology from Villanova University and a B.S. in Biology from Washington and Lee University.  Dr. Robertson commented, "It is a great privilege and wonderful opportunity to become a member of the DOR team. I believe that we have some of best technology to meet the ricin toxin and botulinum toxin bioweapons threats that can help protect those who are on the front lines, both at home and abroad."  About DOR BioPharma, Inc.  DOR BioPharma, Inc. is a biopharmaceutical company focused on the development of biodefense vaccines and therapeutics for areas of unmet medical needs. Through its BioDefense Division, DOR is developing bioengineered vaccines designed to protect against the deadly effects of ricin and botulinum toxins for potential U.S. Government procurement. DOR has also recently announced the initiation of a new botulinum toxin therapeutic development program based on rational drug design. DOR's lead therapeutic product, orBec(R) (an oral formulation of beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host Disease (iGVHD), a severe, life-threatening form of gastrointestinal inflammation. DOR recently announced top line results of its pivotal Phase III clinical trial of orBec(R) in iGVHD in which orBec(R) demonstrated a highly statistically significant reduction in mortality during the prospectively defined Day 200 post-transplant period and positive trends on its primary endpoint. DOR will meet with the FDA in the coming months to determine the appropriate next steps for the development of orBec(R).  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 iGVHD 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 (including that the results of its Phase I clinical trial of RiVax(TM) will demonstrate acceptable safety and immunogenicity/efficacy), 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, that it will be able to maintain its listing on the American Stock Exchange, or that its business strategy will be successful. Important factors which may affect the future use of orBec(R) for iGVHD include the risks that: because orBec(R) did not achieve statistical significance in its primary endpoint in this 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.  SOURCE: DOR BioPharma, Inc.  CONTACT: DOR BioPharma, Inc., Miami Evan Myrianthopoulos, 305-534-3383 http://www.dorbiopharma.com  Copyright Business Wire 2005  -0-  KEYWORD: United States  North America  Florida INDUSTRY KEYWORD: Health  Biotechnology  Pharmaceutical  Other Health  Professional Services  Banking SUBJECT CODE: Personnel  11-Mar-2005 08:00