MORRIS PLAINS, N.J., Dec. 7 /PRNewswire-FirstCall/ -- Immunomedics, Inc. , a leading biopharmaceutical company focused on developing monoclonal antibodies, today announced that U.S. patent 7,151,164 will issue on December 19, 2006, covering methods for treating B-cell disorders using the Company's monoclonal antibody that binds to the CD20 antigen present on B-lymphocytes. The allowed claims cover the use of the Company's product, hA20, which is a humanized anti-CD20 monoclonal antibody for the treatment of B-cell lymphomas, leukemias and autoimmune diseases.
"This patent strengthens our position for the advancement of a new anti-CD20 antibody for the treatment of B-cell mediated diseases. Our hA20 antibody has demonstrated a number of features that we believe differentiate it from other anti-CD20 antibodies, such as more rapid administration, less adverse events during infusion and activity at lower doses," commented Cynthia L. Sullivan, Company President and CEO. "We are particularly interested in the efficacy at lower doses, because this could permit evaluation of different formulation, such as subcutaneous injections, which could be more convenient and economical for doctors and patients," she further remarked.
About hA20
hA20 was constructed using the same human donor frameworks and methods employed to make the Company's anti-CD22 antibody, epratuzumab. Epratuzumab has been studied in over 300 non-Hodgkin's lymphoma (NHL) patients and can be infused within an hour. hA20 displays similar binding avidity, specificity, and mechanisms of action as rituximab, but has structural differences, and to date, shows an excellent safety and tolerability profile, even when infused within 2 hours. At a single low dose of 120 mg/m2, hA20 depleted circulatory B-cells, and produced high complete responses in recurrent NHL patients with prior rituximab treatments when given once weekly over 4 concurrent weeks. Doses between 120 and 750 mg/m2 were evaluated in this multi-center clinical trial. To-date, no patients have shown an elevated immune response to repeated injections of hA20. An update of the ongoing Phase I study of hA20 will be presented next week at the 2006 annual meeting of the American Society of Hematology in Orlando, FL.
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 have recently licensed our lead product candidate, epratuzumab, to UCB, S.A. for the treatment of all autoimmune disease indications worldwide. We have retained the rights for epratuzumab in oncology indications for which UCB has been granted a buy-in option. UCB has development, manufacture and commercialization rights, and is responsible for all clinical trials evaluating epratuzumab for the treatment of patients with moderate and severe lupus. At present, there is no cure for lupus and no new lupus drug has been approved in the U.S. in the last 40 years. We believe that our portfolio of intellectual property, which includes approximately 108 patents issued in the United States, and more than 250 other issued patents worldwide, protects our product candidates and technologies. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel dock and lock methodology, 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. Visit our web site at http://www.immunomedics.com.
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: Dr. Chau Cheng Associate Director, Investor Relations & Business Analysis (973) 605-8200, extension 123 ccheng@immunomedics.com
Immunomedics, Inc.CONTACT: Dr. Chau Cheng, Associate Director, Investor Relations & BusinessAnalysis, +1-973-605-8200, extension 123, ccheng@immunomedics.com
Web site: http://www.immunomedics.com/
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