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Immunomedics Announces U.S. Patents Awarded for CD20 Antibody, Veltuzumab, and Reagents Used in Pretargeted Imaging and Therapies MORRIS PLAINS, N.J., Oct. 14, 2008 (GLOBE NEWSWIRE) -- Immunomedics,
Inc. (NasdaqGM:IMMU - News), a biopharmaceutical company focused
on developing monoclonal antibodies to treat cancer and
other serious diseases, announced that U.S. patent 7,435,803
was issued today covering the composition of matter and
the use of humanized, chimeric and human anti-CD20 antibodies
and antibody fusion proteins or fragments thereof comprising
at least the veltuzumab antibody that targets the CD20 antigen
present on B-lymphocytes, leukemias, and lymphomas. The
allowed claims cover the use of veltuzumab and bispecific
antibody protein constructs for the treatment and diagnosis
of B-cell disorders, such as B-cell malignancies and autoimmune
diseases. The patent also protects the subcutaneous formulation
of veltuzumab, which the Company recently licensed to Nycomed
GmbH for all non-cancer indications. ``We believe the new patent substantially strengthens our intellectual property portfolio relating to anti-CD20 antibodies by protecting chimeric, humanized or human monoclonal antibodies comprising the veltuzumab complementarity-determining region sequences, fusion proteins that incorporate such antibodies, and DNA sequences, vectors, or transfected cells encoding the expression of such antibodies. The patent also protects methods of treating B-cell lymphomas and leukemias, and B-cell related autoimmune diseases, by administering our proprietary anti-CD20 antibodies,'' commented Cynthia L. Sullivan, President and CEO. Additionally, on September 30, 2008, the Company's patent application, ``Production and use of novel peptide-based agents for use with bispecific antibodies,'' was issued as U.S. patent 7,429,381. This patent covers kits and methods of use of bispecific antibodies or fragments comprising the humanized 679 antibody, the Company's proprietary antibody that binds to the histamine-succinyl-glycine (HSG) hapten-peptide. These bispecific antibodies are designed to be used with HSG haptens for the delivery of therapeutic and diagnostic agents in pretargeting methods. Pretargeting techniques potentially can be used for the diagnosis and treatment of a wide variety of diseases, including cancer, autoimmune disease and infectious disease. Because pretargeting preferentially increases the delivery of imaging and therapeutic agents to diseased tissues compared to normal tissues, it results in an increased effectiveness of these agents while decreasing the prevalence of undesirable side effects. ``We believe this patent further strengthens the Company's extensive patent portfolio in the field of diagnostic imaging and therapy,'' commented Ms. Sullivan. About Veltuzumab Constructed using the same donor frameworks as epratuzumab, the Company's anti-CD22 humanized antibody, veltuzumab is an anti-CD20 monoclonal antibody having 90-95% human antibody sequences. Antibody-dependent cell-mediated cytotoxicity, apoptosis and growth inhibition are similar between rituximab and veltuzumab. However, veltuzumab has a significantly lower off-rate (increased residence time on lymphoma cells) in all lymphoma cell lines tested, and demonstrates significantly higher complement-dependent cytotoxicity in certain human lymphoma cells in vitro. Veltuzumab is the first subcutaneously-applied, humanized, anti-CD20 antibody tested in clinical trials and has shown an excellent safety and tolerability profile, providing convenience to patient and physician. To-date, no patients have shown an elevated immune response to repeated injections of veltuzumab. Veltuzumab has completed Phase II clinical trials in patients with NHL, showing a high complete response rate in follicular lymphoma, even at low doses of 80-120 mg/m(2) once-weekly for 4 weeks. Patients with ITP have also responded to low doses of veltuzumab in an ongoing Phase I/II clinical trial. 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 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 also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology for making fusion proteins and multifunctional antibodies, 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. We believe that our portfolio of intellectual property, which includes approximately 116 patents issued in the United States and more than 295 other patents issued worldwide, protects our product candidates and technologies. For additional information on us, please visit our website at http://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, 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), our dependence on our licensing partners for the further development of epratuzumab for autoimmune indications and veltuzumab 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: Immunomedics
Dr. Chau Cheng, Associate Director, Investor Relations &
Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com
Source: Immunomedics, Inc.
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