Healthcare Industry News: Dock-and-Lock
News Release - March 18, 2008
Immunomedics' Milatuzumab Receives FDA Orphan Drug Designation for Therapy of Multiple MyelomaMORRIS PLAINS, N.J., March 18, 2008 (Healthcare Sales & Marketing Network) -- Immunomedics, Inc., (NasdaqGM:IMMU ), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to milatuzumab for the treatment of multiple myeloma.
The designation allows the Company to have a seven-year market exclusivity for milatuzumab in multiple myeloma upon final approval by the FDA. Other financial benefits and incentives include waiver of Prescription Drug User Fee Act (PDUFA) filing fees, tax credits for the costs of clinical research, and assistance in clinical research study designs.
``We are pleased to receive Orphan Drug designation for milatuzumab. Preclinical studies by us and other scientists have shown that milatuzumab inhibits the growth of human multiple myeloma and lymphoma cells in culture and in mouse models, and blocks the over-expression of CD74 in chronic lymphocytic leukemia cells, which leads to increased cell death. We have initiated Phase I/II studies to evaluate the therapeutic potential of milatuzumab in patients with multiple myeloma, non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL),'' commented Cynthia L. Sullivan, President and CEO.
In addition, John P Leonard, MD, Professor of Medicine at Weill Medical College of Cornell University, is conducting a Phase I study in patients with recurrent NHL or CLL funded in part by a grant from the National Cancer Institute.
About Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells, a type of white blood cell, which typically occurs in older patients. According to the American Cancer Society, there will be an estimated 19,920 new cases of multiple myeloma and 10,690 deaths from this disease in the United States in 2008. Standard treatments include anticancer drugs, steroids, stem cell transplantation, and radiation therapy. The overall five-year survival rate is 34%.
Milatuzumab is a humanized anti-CD74 antibody constructed using the same human backbone as epratuzumab, whose safety has been demonstrated in clinical trials of patients with B-cell malignancies and autoimmune disorders. Milatuzumab is being studied for the treatment of multiple myeloma, non-Hodgkin's lymphoma, and chronic lymphocytic leukemia.
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 exclusively licensed our lead product candidate, epratuzumab, to UCB (http://www.ucb-group.com) for the treatment of all autoimmune disease indications worldwide. Epratuzumab's most advanced program is for the treatment of systemic lupus erythematosus (SLE). 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 have retained the rights for epratuzumab in oncology indications for which UCB has been granted a buy-in option. The Company is conducting clinical trials with veltuzumab in patients with non-Hodgkin's lymphoma and immune thrombocytopenic purpura, epratuzumab as a potential therapeutic for patients with lymphoma and leukemia, 90Y-epratuzumab for the therapy of patients with lymphoma, 90Y-hPAM4 for pancreas cancer therapy and milatuzumab as a therapy for patients with multiple myeloma, non-Hodgkin's lymphoma, and chronic lymphocytic leukemia. 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 (DNL) 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. 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, patent protection, 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 partner for the further development of epratuzumab for autoimmune 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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