Healthcare Industry News:  fast track designation 

Biopharmaceuticals Oncology FDA

 News Release - February 5, 2009

Immunomedics' hPAM4 Labeled With Yttrium-90 Receives Fast Track Designation From FDA for Therapy of Pancreatic Cancer

MORRIS PLAINS, N.J., Feb. 5, 2009 -- (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 it has received notice from the U.S. Food and Drug Administration (FDA) granting yttrium-90-labeled hPAM4 fast track designation for the treatment of pancreatic cancer.

The fast track programs, under the FDA Modernization Act of 1997, are designed to facilitate drug development and to expedite the review of new drugs that are intended to treat serious or life threatening conditions. Compounds selected must demonstrate the potential to address unmet medical needs. The fast track designation allows for close and frequent interaction with the agency. A designated fast track drug may also be considered for priority review with a shortened review time, rolling submission, and accelerated approval if applicable. The designation does not, however, guarantee approval or expedited approval of any application for the product.

``We are pleased to receive the fast track designation from the FDA which is an acknowledgement of the need for viable treatment options for patients with pancreatic cancer,'' remarked Cynthia L. Sullivan, President and CEO. ``The current Phase Ib fractionated dose-escalating study of hPAM4 in combination with gemcitabine is enrolling patients as fast as the protocol permits and we look forward to closely working with FDA for the development and regulatory review of this important new antibody, a potential first-in-class radioimmunotherapeutic agent for pancreatic cancer,'' continued Ms. Sullivan.

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 134 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 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.

Source: Immunomedics

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