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Immunomedics
, 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.
About Immunomedics
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(TM)
(DNL(TM)) method with us for making fusion proteins and multifunctional
antibodies. DNL(TM) 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.
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