- Immunomedics will receive initial payments totaling 38 million
U.S. dollars -
MORRIS PLAINS, N.J. and BRUSSELS, Belgium, May 10
/PRNewswire-FirstCall/ -- Immunomedics, Inc. (Nasdaq: IMMU), a
biopharmaceutical company focused on developing therapeutic monoclonal
antibodies, and UCB (Euronext Brussels: UCB), a leading global
biopharmaceutical company, today announced a collaboration and license
agreement for Immunomedics' lead product, epratuzumab. The agreement grants
UCB the exclusive worldwide rights to develop, market and sell epratuzumab
for all autoimmune disease indications. Epratuzumab's most advanced program
is for the treatment of Systemic Lupus Erythematosus (SLE): it has been
granted FDA Fast Track designation and is currently undergoing two phase
III clinical trials.
Immunomedics will receive initial cash payments totaling, before fees,
38 million U.S. dollars over the next ten business days and could receive
potential milestone payments of up to 145 million U.S. dollars in cash and
20 million U.S. dollars in equity investments, depending on geography
approval and approval in different indications over several years. In
addition to receiving royalties on sales, Immunomedics could also receive
sales bonuses upon reaching certain sales target levels.
"We are excited to collaborate with UCB, since they have demonstrated
leadership in the development of monoclonal antibodies. We believe that
they are well suited to optimize the potential of epratuzumab in multiple
autoimmune disease indications," commented Cynthia L. Sullivan, President
and Chief Executive Officer of Immunomedics. "Furthermore, our business
strategy of out-licensing compounds in late stage clinical development for
markets with unmet medical needs fits exceedingly well with UCB's focus on
securing leading positions in severe disease categories through its
successful worldwide marketing and sales organization. We look forward to
bringing epratuzumab to patients with autoimmune disorders through this
collaboration," she added.
"We are pleased to enter into this collaboration with Immunomedics, a
focused monoclonal antibody research and bio-manufacturing company.
Epratuzumab is a promising molecule which we expect to complement our
existing portfolio in autoimmune and inflammatory diseases. It offers a
unique mechanism of action in targeting B-cells, which is very
complementary to UCB's T-cell expertise. UCB plans to escalate activity in
the ongoing Phase III studies, with timelines and milestones to be updated
when fully integrated into our existing portfolio. The focus during our
evaluation of epratuzumab was on autoimmune indications, driven by the very
compelling clinical data in SLE, and our interest in furthering the
molecule in this and other autoimmune diseases," said Melanie Lee,
Executive Vice President, Research & Development of UCB.
Under the terms of the agreement, UCB will assume all costs associated
with current and future clinical development and commercialization of
epratuzumab for the treatment of patients with SLE.
About Epratuzumab
Epratuzumab, a humanized monoclonal antibody against the CD22 marker
expressed on activated B-cells, was developed and manufactured internally
at Immunomedics, and is covered by worldwide patent estate. It is
Immunomedics' lead product candidate being evaluated in two international
pivotal Phase III ("Alleviate A and B") trials for the treatment of
moderate and severe SLE. The FDA granted a Fast Track designation to the
clinical development program for epratuzumab for the treatment of patients
with SLE, following Immunomedics' completion of a Phase II trial.
Epratuzumab has also demonstrated good safety, tolerability, and
clinical activity in more than 340 patients with non-Hodgkin's lymphoma,
resulting in reports published in The Journal of Clinical Oncology and
Clinical Cancer Research. Three studies have been completed which indicate
a potential value in combining epratuzumab with rituximab, an approved CD20
monoclonal antibody.
About Systemic Lupus Erythematosus
Systemic Lupus Erythematosus (SLE) is a complex systemic autoimmune
disease of unknown etiology characterized by cellular and humoral defects,
resulting in a breakdown of immunological tolerance and production of auto
antibodies to a broad spectrum of nuclear antigens. Like other autoimmune
diseases, genetic and environmental influences are thought to trigger
disease. The clinical findings in SLE vary greatly and may begin abruptly
with fever simulating acute infection or may develop over months or years
with periodic episodes.
Incidence of SLE is thought to vary between 24-65 cases per 100,000
people in the US and EU, although some reports from the USA suggest a much
higher incidence. The disease has a gender bias and principally affects
women (90%).
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 believe that our
portfolio of intellectual property, which includes approximately 90 patents
issued in the United States, and more than 250 other issued patents
worldwide, protects our product candidates and technologies. Visit our web
site at http://www.immunomedics.com. We also have a majority ownership in
IBC Pharmaceuticals, Inc., which is developing a novel dock and lock
platform technology, 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.
About UCB
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 8,500 people in over
40 countries, UCB achieved revenue of 2.3 billion euro in 2005. UCB is
listed on the Euronext Brussels Exchange with a market capitalisation of
approximately 6.0 billion euro. Worldwide headquarters are located in
Brussels, Belgium.
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. UCB
Dr. Chau Cheng Jean-Christophe Donck
Associate Director Vice President
Investor Relations & Corporate Communications &
Business Analysis Investor Relations
(973) 605-8200, extension 123 +32.2.559.9346
ccheng@immunomedics.com jc.donck@ucb-group.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, Associate Director, Investor
Relations & Business Analysis, of Immunomedics, Inc.,
+1-973-605-8200, ext. 123, ccheng@immunomedics.com;
Jean-Christophe Donck, Vice President, Corporate Communications &
Investor Relations, of UCB, +32-2-559-9346,
jc.donck@ucb-group.com
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