MORRIS PLAINS, N.J., Dec. 19, 2008 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA) has issued a positive opinion on the Company's application for orphan designation of yttrium-90 labeled hPAM4 for the treatment of pancreatic cancer.
According to EMEA, orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 persons in the European Union. Companies with an orphan designation for a medicinal product benefit from incentives such as fee waivers, a 10 year market exclusivity period post authorization for designated products; scientific assistance for marketing authorizations, and the possibility of a Community marketing authorization.
"With this designation from EMEA, the Company now has orphan drug status for PAM4 in the two major markets, United States and the European Union, for pancreatic cancer treatment," commented Cynthia L. Sullivan, President and CEO. "Enrollment in the ongoing Phase Ib clinical trial is progressing well," she continued.
About hPAM4
hPAM4 is a humanized monoclonal antibody targeting an epitope in the MUC1 antigen expressed in most pancreatic cancer, but not pancreatitis, normal pancreas or most other normal tissues. Preclinical studies with PAM4 labeled with the radioisotope, yttrium-90, demonstrated favorable tumor responses, which could be further improved when given in combination with gemcitabine. The Phase I single dose-escalation study of yttrium-90 labeled hPAM4 in pancreatic cancer patients has also produced encouraging results. The radiolabeled humanized antibody is currently in a Phase Ib fractionated dose-escalation study in combination with gemcitabine for the treatment of patients with newly diagnosed stage III or stage IV cancer of the pancreas.
About Pancreatic Cancer
According to the National Cancer Institute, pancreatic cancer is the fourth leading cause of cancer death in the United States. In 2008, an estimated 37,680 Americans will be diagnosed with the disease, and about 34,290 patients will die from it. For those patients with small and localized disease that can be completely resected surgically, 5-year survival rates improve to 18% to 24%. Currently, the standard therapy for pancreatic cancer is gemcitabine, alone or in combination with other chemotherapeutics.
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 123 patents issued in the United States and more than 300 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.