Filter News

DOR BioPharma, Inc. And Cambrex Corporation Enter Into A Development And Manufacturing Process Agreement For RiVax(TM)

Published: Jan 07, 2005

MIAMI and EAST RUTHERFORD, N.J., Jan. 7 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc. and a subsidiary of Cambrex Corporation have entered into an agreement with respect to process development for potential large scale production of DOR's proprietary ricin vaccine, RiVax(TM). Under the agreement, Cambrex will provide process development and cGMP (current Good Manufacturing Processes) production services for RiVax(TM).

(Logo: http://www.newscom.com/cgi-bin/prnh/20000613/CAMBREXLOGO )

Ricin toxin is a potential bioterror threat due to its highly lethal toxicity in small doses, ease of manufacture, and ability to be aerosolized. The need for protective countermeasures against ricin has been emphasized by its recent and continued use as a biological weapon.

"We believe RiVax(TM) could be an integral part of the U.S. Government's biodefense arsenal," stated Gregory J. Davenport, Ph.D., President of DOR's Biodefense Division. "Cambrex has significant cGMP capacity and a proven track record of manufacturing other developmental vaccines. We are pleased to be working with Cambrex as we endeavor to meet all the requirements for potential procurement by the U.S. Government."

DOR will work with Cambrex pursuant to DOR's recently awarded $5.2 million National Institutes of Health (NIH) ricin vaccine development grant. The specific milestones for the RiVax(TM) development program funded under the grant to be undertaken by Cambrex include development of a robust process for production and purification of the vaccine. Under the current agreement, Cambrex will be developing the manufacturing process to enable large scale production to produce quantities sufficient for additional clinical testing, fulfillment of all FDA requirements for licensure and, approved, commercial production.

"If these milestones are successfully achieved, DOR will have sufficient vaccine available for future clinical trials, and will be capable of manufacturing RiVax(TM) at scale," commented Alexander P. Haig, Executive Chairman of DOR. "Our goal is to position ourselves as a qualified supplier of ricin vaccine to the U.S. Government. We intend to aggressively pursue all future procurement contracts with the ultimate goal of providing a safe and effective ricin vaccine to our military and at-risk civilians."

"We are excited to work with DOR on the RiVax(TM) project," commented Gary Mossman, Chief Operating Officer of Cambrex. "We have extensive experience developing production capabilities for vaccines of all types, and we feel privileged to work on this important vaccine that could be a critical component of our national defense."

In accordance with current FDA guidance, DOR has previously demonstrated the safety and effectiveness of RiVax(TM) in multiple relevant animal models. The Company has recently announced the initiation of an investigator-sponsored Phase I clinical study to be conducted at the University of Texas, to test the safety and immunogenicity of RiVax(TM) in human volunteers using previously produced cGMP material from UT Southwestern. Once these conditions are satisfied, the federal government has the authority under the BioShield Act of 2004 to procure bioterror countermeasures for addition to the Strategic National Stockpile prior to Food and Drug Administration approval.

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 toxin and botulinum toxin. DOR's lead therapeutic product, orBec(R) (an oral formulation of beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed to treat inflammation in the mucosal lining of the intestine and stomach that can occur following allogeneic bone marrow and stem cell transplants. DOR plans to meet with FDA as soon as possible to review the data from its pivotal Phase III clinical trial in intestinal Graft-versus-Host Disease. For further information regarding DOR BioPharma, please visit the Company's website located at http://www.dorbiopharma.com/.

About Cambrex

Cambrex is a global, diversified life science company dedicated to providing products and services to accelerate the discovery and commercialization of human therapeutics. The Company employs approximately 1900 people worldwide. For more information, please visit Cambrex's website at http://www.cambrex.com/.

Forward Looking Statements

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. 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, 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; that it will be able to maintain its listing on the American Stock Exchange; or that its business strategy will be successful. 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.

Photo: http://www.newscom.com/cgi-bin/prnh/20000613/CAMBREXLOGOCambrex Corporation

CONTACT: Evan Myrianthopoulos, Chief Financial Officer of DOR BioPharma,Inc., +1-305-534-3383; or Anne-Marie Hess, Director, IR & CorporateCommunications of Cambrex Corporation, +1-201-804-3062, orannemarie.hess@cambrex.com

Back to news