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DOR BioPharma and Dowpharma Enter into a Joint Development Agreement for BT-VACC, DOR’s Oral Botulinum Toxin Vaccine Miami, FL - July 26, 2005 DOR BioPharma, Inc. (AMEX: DOR) ("DOR", or the "Company") today announced it has entered into a joint development agreement with DowpharmaSM contract manufacturing services, a business unit of The Dow Chemical Company (NYSE: DOW), to advance the development of DOR's proprietary oral botulinum vaccine, BT-VACC™. BT-VACC is designed to protect against botulism poisoning, which is one of the top five bioterrorism threats identified by the U.S. government. Under the agreement, Dowpharma will provide process development leading to current Good Manufacturing Practices (cGMP) production services for BT-VACC using its Pfēnex Expression Technology™, a Pseudomonas-based technology that accelerates speed to market for vaccines and biotherapeutics by surpassing the quality and yield capabilities of existing microbial systems. DOR's BT-VACC is an orally administered vaccine that protects against exposure to botulinum neurotoxins. Oral administration of BT-VACC produces protective antibodies that afford protection or prolonged survival of treated animals against 30,000 times the lethal dose of botulinum toxin serotype A. The oral route of administration of a vaccine is believed to be preferable to the injectable form due to benefits derived from safer and easier administration, lack of skilled medical personnel needed for administration, and relative ease of distribution to the civilian population. DOR believes that it is the only company developing an orally delivered botulinum toxin vaccine. Recent preclinical studies of BT-VACC for serotype B resulted in similar immunogenicity and protective efficacy results. Ongoing studies at Thomas Jefferson University are focused on serotype E and multivalent immunization experiments using serotype A, B and E antigens given simultaneously to animals. "This is an important relationship for us as we continue to develop BT-VACC," commented Michael T. Sember, president and CEO of DOR BioPharma, Inc. "Results to date indicate that BT-VACC has the ability to induce protective antibodies in appropriate animal models. With Dowpharma's Pfēnex Expression Technology, we intend to aggressively expedite the production of multiple botulinum toxin serotype antigens from the laboratory to cGMP production so that we can rapidly advance BT-VACC into the clinic." Dowpharma has an unmatched record in developing high-productivity strains of numerous protein products, for both clinical and industrial applications. Dowpharma has developed a Pseudomonas-based technology and know-how directed toward protein expression and downstream processing of expressed proteins and other biologically active compounds known as Pfēnex Expression Technology. Pfēnex is built around specially modified strains of Pseudomonas fluorescens bacteria that increase cellular expression of recombinant proteins and peptides while maintaining critical solubility and activity characteristics. "Dowpharma is committed to the development of biodefense products, as this is our third program to address bioterrorism threats," said Nick Hyde, business director, Dowpharma. "Pfēnex is proven to improve protein production and consistently outperforms other commercially available microbial expression systems such as E. coli, and we are honored to work with DOR to expedite the development of this important vaccine." Botulinum toxin, considered the most poisonous natural substance known to mankind, is classified as a Category A biothreat by the Centers for Disease Control (CDC), and has been used in a number of well-documented incidents. It is 100,000 times more toxic than sarin gas, and currently there is no FDA approved vaccine or therapeutic. The toxin is known to exist in seven different serotypes, designated A to G, but only three (A, B and E) account for almost all human cases of disease. Once exposed to botulinum toxin, blockage of peripheral nerve function and descending flaccid paralysis occurs which ultimately leads to death within hours. About DOR BioPharma, Inc. DOR BioPharma, Inc. is a biopharmaceutical company focused on the development of therapeutic products and biomedical countermeasures for areas of unmet medical need. Our lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host disease (iGVHD), a common serious complication of bone marrow transplantation for cancer, as well as other gastrointestinal disorders characterized by severe inflammation. We intend to file a new drug application (NDA) with the FDA for orBec® for the treatment of iGVHD later this year. Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the paradigm established by the recently enacted Project BioShield Act of 2004. Our biodefense products in development are bioengineered vaccines designed to protect against ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine, RiVax™, is currently the subject of a Phase I clinical trial in normal volunteers. We have also recently announced the initiation of a new 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. For Editorial Information: Evan Myrianthopoulos Kathleen Davis |
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