MIAMI and EAST RUTHERFORD, N.J., July 20, 2005 (PRIMEZONE) -- DOR BioPharma, Inc. (AMEX:DOR) ("DOR", or the "Company") and a subsidiary of Cambrex Corporation (NYSE:CBM) today announced that they have successfully achieved, ahead of schedule, the first milestone of fermentation and downstream process development in their development and manufacturing agreement for RiVax(tm), DOR's ricin toxin vaccine.
DOR and Cambrex entered into an agreement in January 2005 under which Cambrex would provide process development and cGMP (current Good Manufacturing Processes) production services for the development and manufacture of clinical quantities of RiVax(tm). The companies' work has been conducted under a Challenge Grant totaling $6.4 million awarded to DOR in September 2004 by the National Institute of Allergy and Infectious Diseases (NIAID), a unit of the National Institutes of Health. The Challenge Grant program was created by NIAID to stimulate participation by industry in research on specific infectious diseases of public health importance.
"We are very pleased with the substantial progress we have made with Cambrex thus far," stated Michael T. Sember, DOR's CEO and President. "Cambrex took a low yield E coli process and achieved a 10 fold increase in yields. Cambrex's proven capabilities in cGMP manufacturing will go a long way in ensuring, through this agreement, that sufficient quantities of RiVax(tm) are available to support further commercial development activities and potential purchases by the U.S. government and allied nations."
Based on the successful completion of this milestone, DOR and Cambrex have decided to extend their development and manufacturing agreement. Under this next phase of the agreement, the companies will work to enable the large-scale production of RiVax(tm) for additional clinical testing and eventual commercial production.
"It is extremely rewarding to work with DOR in support of our national biodefense program," commented Steve Klosk, Chief Operating Officer of Cambrex's Biopharmaceutical business. "We are very pleased that DOR has selected Cambrex as their manufacturer of choice for the potential commercialization of RiVax(tm)."
Ricin toxin is a potential bioterror threat due to its highly lethal toxicity in small doses, ease of manufacture, and ability to be aerosolized. Exposure to small amounts, especially by inhalation, can lead to lung damage, nausea, fever, abdominal pain, and death within several days. The need for protective countermeasures against ricin has been emphasized by its recent and continued use as a biological weapon. Currently there are no FDA approved vaccines against ricin toxin. DOR has recently announced positive interim results from its Phase I clinical trial of RiVax(tm), which is the first ricin toxin vaccine ever to be clinically tested in humans.
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(r) (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(r) 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 the deadly effects of ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine, RiVax(tm), 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.
About Cambrex Corporation
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 1,900 people worldwide. For more information please visit the Cambrex website located at www.cambrex.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 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.