MIAMI and EAST RUTHERFORD, N.J., Jan. 7 /PRNewswire-FirstCall/ -- DOR
BioPharma, Inc. (Amex: DOR) and a subsidiary of Cambrex Corporation
(NYSE: CBM) 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.
SOURCE Cambrex Corporation
 back to top
Related links:
http://www.cambrex.com
http://www.dorbiopharma.com
Photo Notes:http://www.newscom.com/cgi-bin/prnh/20000613/CAMBREXLOGO
Company News On-Call:
http://www.prnewswire.com/comp/134219.html
CONTACT:
Evan Myrianthopoulos, Chief Financial Officer
of DOR BioPharma, Inc., +1-305-534-3383; or Anne-Marie Hess,
Director, IR & Corporate Communications of Cambrex Corporation,
+1-201-804-3062, or annemarie.hess@cambrex.com
|
