Immunomedics Announces Termination of Agreement and Return of Worldwide Rights
to Veltuzumab for All Non-Cancer Indications
MORRIS PLAINS, N.J., Oct. 9, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc.
(Nasdaq:IMMU), a biopharmaceutical company primarily focused on the
development of monoclonal antibody-based products for the targeted treatment
of cancer, autoimmune and other serious diseases, today announced that the
Company has received notification from Takeda Pharmaceutical Company of the
termination of the licensing agreement signed between Nycomed GmbH and
Immunomedics for the worldwide rights to veltuzumab, the humanized anti-CD20
antibody, for all non-cancer indications.
The notification was received subsequent to the Company's filing of
arbitration proceedings in an effort to resolve the dispute the Company has
with Nycomed concerning delays in the development of veltuzumab, which the
Company argues is a material breach of the licensing agreement.
As a result of the termination, all rights to veltuzumab revert to the Company
and both parties have begun discussions regarding the transition of veltuzumab
back to the Company. In addition, the Company will continue to pursue the
arbitration procedure to address its claim for damages due to delays in the
development of veltuzumab and expects the arbitration to continue while the
product transition takes place.
"I want to emphasize that this transfer of veltuzumab back to us is not due to
a lack of efficacy or safety of the antibody but a lack of progress with its
development," commented Cynthia L. Sullivan, President and Chief Executive
Officer of Immunomedics. "We have begun the process of evaluating our options
for this important antibody," Ms. Sullivan added.
The Company licensed the worldwide rights to develop, manufacture and
commercialize veltuzumab, in the subcutaneous formulation, for the treatment
of all non-cancer indications to Nycomed GmbH in July 2008. Nycomed was
acquired by Takeda Pharmaceutical Company in September, 2011.
Immunomedics is a New Jersey-based biopharmaceutical company primarily 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, cytokines 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.Our lead product candidate,
epratuzumab, is currently in two Phase III clinical trials in lupus. In
oncology, we are planning to launch a Phase III pivotal trial for clivatuzumab
labeled with a radioisotope in advanced pancreatic cancer patients. Other
solid tumor therapeutics in Phase II clinical development include 2
antibody-drug conjugates, labetuzumab-SN-38 (IMMU-130) and hRS7-SN-38
(IMMU-132).We also have a majority ownership in IBC Pharmaceuticals, Inc.,
which is developing a novel DOCK-AND-LOCK™ (DNL™) method with us for making
fusion proteins and multifunctional antibodies. DNL™ is being used
particularly to make bispecific antibodies targeting cancers and infectious
diseases as a T-cell redirecting immunotherapy, as well as bispecific
antibodies for next-generation cancer and autoimmune disease therapies. We
believe that our portfolio of intellectual property, which includes
approximately 230 active patents in the United States and more than 400
foreign patents, protects our product candidates and technologies.Our
strength in intellectual property has resulted in the top-10 ranking in the
2012 IEEE Spectrum Patent Power Scorecards in the Biotechnology and
Pharmaceuticals category.For additional information on us, please visit our
website at www.immunomedics.com. The information on our website does not,
however, form a part of this press release.
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), forecasts of future operating results, potential
collaborations, 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 any cash payment that the Company might
receive in connection with a sublicense involving a third party and UCB, which
is not within the Company's control, new product development (including
clinical trials outcome and regulatory requirements/actions), our dependence
on UCB for the further development of epratuzumab for non-cancer indications,
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.
CONTACT: For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Grant Management
(973) 605-8200, extension 123
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