Immunomedics files for European regulatory approval of infectious disease detection product, LeukoScan.

MORRIS PLAINS, N.J.--(HealthWire)--August 1, 1995--Immunomedics Inc. (NASDAQ; IMMU) announced today that it has filed an application with the European Medicines Evaluation Agency ("EMEA") for approval to market LeukoScan(R), its monoclonal antibody-based agent for the detection and diagnosis of osteomyelitis (bone infection) in long bones and diabetic foot ulcers.

By filing with the EMEA, the company is seeking European Union approval in all fifteen member states.

LuekoScan(R) is a monoclonal anitbody fragment directly labeled with technetium-99m, an inexpensive frequently used radioisotope with high quality imaging capability. Following a simple, five-minute labeling procedure, a small amount of the antibody is administered to the patient. The antibody seeks out and binds to granulocytes (white blood cells) associated with a potentially wide range of infectious diseases, and carries the radioisotope to the infection site. The patient can be imaged, in certain circumstances within an hour of administration, using a standard nuclear medicine gamma camera.

Currently, infectious disease and nuclear medicine specialists use indium-111 labeled white blood cells to image infectious disease. This procedure requires withdrawing a patient's blood sample to isolate white blood cells, labelling those with these cells with indium-111 before re-injection into the patient, followed by a 24 to 48-hour waiting period before the imaging procedure can be performed. This extended process delays treatment decisions and necessitates the handling of potentially infectious blood samples.

"We believe that quick and easy preparation of LeukoScan(R), the shorter waiting time between administration and imaging, and the elimination of patient blood handling may give LeukoScan(R) significant clinical advantages over indium-111 labeled white blood cell imaging procedures," said Dr. David Goldenberg, chairman of Immunomedics. "We are seeking a corporate partner with established marketing and sales operations to assist in the commercialization of LeukoScan(R) in Europe."

Clinical data from all the sites participating in the Phase III trial for LeukoScan(R) will be presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy ("ICAAC") in September. The company is continuing to enroll patients into the Phase III clinical trials, particularly for infected prosthesis and appendicitis indications for this product. As with all regulatory filings, in general, there can be no assurance that the application will be approved by the EMEA or, more specifically, that comparability of LeukoScan(R) to indium-111 white blood cell imaging will be an adequate basis for regulatory approval.

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. The company's colorectal cancer imaging agent, CEA-Scan(TM), is under review for marketing approval by the U.S. Food and Drug Administration, as well as by regulatory agencies in Europe and Canada. In addition, Immunomedics currently has a therapeutic product and several other diagnostic imaging products in clinical trials.

CONTACT: Immunomedics Inc.

Amy Factor, 201/605-8200