Immunomedics to present CEA-Scan to FDA advisory panel February 16, 1996.

MORRIS PLAINS, N. J.--(HealthWire)--Jan. 12, 1996--Immunomedics, Inc. (NASDAQ: IMMU) announced today that the U.S. Food and Drug Administration (FDA) has scheduled the Company to present its colorectal cancer imaging agent, CEA-Scan(TM), for review by the FDA's Medical Imaging Drugs Advisory Committee (MIDAC) on February 16, 1996.

MIDAC is comprised of imaging specialists; however, the Committee will be supplemented with medical and surgical oncologists for the February 16, 1996 review of CEA-Scan(TM).

"We appreciate the FDA's efforts that have facilitated the review of our application by MIDAC and we believe that all significant differences concerning data and image interpretation, between the Company and the FDA have been resolved," commented Dr. David M. Goldenberg, chairman of Immunomedics, Inc. "We are working with the FDA in an effort to prepare a cohesive presentation to MIDAC," he added.

CEA-Scan(TM) comprises an antibody fragment (Fab') of a mouse monoclonal antibody against the tumor marker, carcinoembryonic antigen (CEA). "CEA is expressed by more than 90% of colorectal cancers as well as by a large number of other carcinomas, such as those of the lungs, breast, pancreas, uterus and ovary, and it has been shown that this tumor marker can serve as a useful target for radiolabeled antibodies," noted Dr. Goldenberg. In the the United States, colorectal cancer cases increase by about 138,000 each year, and colorectal cancer is estimated to kill over 48,000 Americans annually. "Using a small antibody fragment at a low dose has made the product virtually free of an immune reaction by the patient to the foreign protein, while linking the fragment with technetium-99m, a very common radioisotope in nuclear medicine permits tumor detection within a few hours, using conventional nuclear cameras," Dr. Goldenberg said.

"We plan to present data supporting the use of CEA-Scan(TM) to better define the spread of colorectal cancer, especially in combination with computed tomography, and which should help avoid unnecessary surgery in patients who would not benefit from this intervention," Dr. Goldenberg explained. He cautioned, however, "We are, of course, unable to predict either the judgement of the advisory panel, or the final decision by the FDA. Nor are we able to predict when either decision will be announced. On October 17, 1995 the FDA's Oncologic Drugs Advisory Committee deferred a decision on the approvability of CEA-Scan(TM) and recommended that the product be reviewed by MIDAC and select oncology consultants and further recommended that the Company and the FDA resolve certain differences in data and imaging interpretation. The current status of the Company's Product License Application on CEA-Scan(TM) for colorectal cancer imaging remains not-approvable, pending the outcome of the MIDAC meeting and Immunomedics resolving all issues to the satisfaction of the FDA.

Immunomedics is a biopharmaceutical company applying innovative technology in antibody selection, modification and chemistry to the development of products for the detection and treatment of cancer and infectious diseases. Integral to these products are highly specific monoclonal antibodies designed to deliver radioisotopes and chemotherapeutic agents to tumors and sites of infectious or other diseases. In addition to CEA-Scan(TM), the Company's infectious disease imaging agent, LeukoScan(R), is undergoing regulatory review in Europe for imaging osteomyelitis (bone infections). Immunomedics also has several other diagnostic imaging products and a therapeutic product in human clinical trials.

CONTACT: Immunomedics, Inc.

Amy Factor, 201/605-8200