MORRIS PLAINS, N.J., Nov. 14 /PRNewswire-FirstCall/ -- Immunomedics,
Inc. (Nasdaq: IMMU), a biopharmaceutical company focused on developing
therapeutic monoclonal antibodies, today announced that their partner, UCB
(Euronext Brussels: UCB), has received notification from FDA that the
clinical hold on existing trials with epratuzumab in patients with lupus
has been lifted.
"We are pleased that the FDA has agreed to remove the clinical hold
status of the trials, and we plan to continue to work closely with UCB to
make epratuzumab available to patients who were in the suspended trials,
and who remain in urgent need," commented Cynthia L. Sullivan, President
and Chief Executive Officer of Immunomedics.
Protocol amendments will now be submitted to Institutional Review
Boards to seek approval to treat patients who remain on the currently
suspended studies, and who are in need of re-treatment.
The clinical hold status resulted from observations by UCB after a
routine audit of the end-stage manufacturing processes by Immunomedics,
which resulted in UCB's concerns regarding sterility assurance of the final
product.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company focused on
the development of monoclonal, antibody-based products for the targeted
treatment of cancer, autoimmune and other serious diseases. We have
developed a number of advanced proprietary technologies that allow us to
create humanized antibodies that can be used either alone in unlabeled or
"naked" form, or conjugated with radioactive isotopes, chemotherapeutics or
toxins, in each case to create highly targeted agents. Using these
technologies, we have built a pipeline of therapeutic product candidates
that utilize several different mechanisms of action. We have recently
licensed our lead product candidate, epratuzumab, to UCB for the treatment
of all autoimmune disease indications worldwide. We have retained the
rights for epratuzumab in oncology indications for which UCB has been
granted a buy-in option. UCB has development, manufacture and
commercialization rights, and is responsible for all clinical trials
evaluating epratuzumab for the treatment of patients with moderate and
severe lupus. At present, there is no cure for lupus and no new lupus drug
has been approved in the U.S. in the last 40 years. We believe that our
portfolio of intellectual property, which includes approximately 108
patents issued in the United States, and more than 250 other issued patents
worldwide, protects our product candidates and technologies. We also have a
majority ownership in IBC Pharmaceuticals, Inc., which is developing a
novel dock and lock methodology, and a new method of delivering imaging and
therapeutic agents selectively to disease, especially different solid
cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based,
pretargeting methods. Visit our web site at http://www.immunomedics.com.
About UCB
Headquartered in Brussels (Belgium), UCB (http://www.ucb-group.com) is
a leading global biopharmaceutical company dedicated to the research,
development and commercialisation of innovative pharmaceutical and
biotechnology products in the fields of central nervous system disorders,
allergy/respiratory diseases, immune and inflammatory disorders and
oncology - - UCB focuses on securing a leading position in severe disease
categories. Employing over 8,300 people in over 40 countries, UCB achieved
revenue of 2.3 billion euro in 2005. UCB is listed on the Euronext Brussels
Exchange.
This release, in addition to historical information, may contain
forward- looking statements made pursuant to the Private Securities
Litigation Reform Act of 1995. Such statements, including statements
regarding clinical trials, out-licensing arrangements (including the timing
and amount of contingent payments), and capital raising activities, involve
significant risks and uncertainties and actual results could differ
materially from those expressed or implied herein. Factors that could cause
such differences include, but are not limited to, risks associated with new
product development (including clinical trials outcome and regulatory
requirements/actions), competitive risks to marketed products and
availability of required financing and other sources of funds on acceptable
terms, if at all, as well as the risks discussed in the Company's filings
with the Securities and Exchange Commission. The Company is not under any
obligation, and the Company expressly disclaims any obligation, to update
or alter any forward-looking statements, whether as a result of new
information, future events or otherwise.
For More Information:
Immunomedics, Inc.
Dr. Chau Cheng
Associate Director
Investor Relations & Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com
SOURCE Immunomedics, Inc.
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Related links:
http://www.immunomedics.com
http://www.ucb-group.com
http://www.prnewswire.com/comp/113121.html/
CONTACT:
Dr. Chau Cheng of Immunomedics, Inc.,
Associate Director, Investor Relations & Business Analysis,
+1-973-605-8200, ext. 123, ccheng@immunomedics.com
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