Exhibit 99.1
IMMUNOMEDICS AND UCB ANNOUNCE WORLDWIDE DEVELOPMENT COLLABORATION AND
LICENSE AGREEMENT FOR EPRATUZUMAB
- 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.
-0- 05/10/2006
/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/
/Company News On-Call: http://www.prnewswire.com/comp/113121.html/
/Web site: http://www.immunomedics.com
http://www.ucb-group.com /
(IMMU)