Canada Approves of LeukoScan(R) for osteomyelitis detection - Immunomedics

Main Category: Bones / Orthopedics
Article Date: 21 Jan 2005 - 9:00 PDT


Immunomedics, Inc (Nasdaq: IMMU) today announced that the Biologics and Genetics Therapies Directorate at the Health Products and Food Branch of Health Canada has approved the marketing and use of LeukoScan(R) (sulesomab) for the detection of osteomyelitis.

"We are pleased that the Canadian government has approved this important diagnostic product for imaging bone infection. The advantage of LeukoScan(R) is its ease of use and that it eliminates the multiple risks associated with the conventional white blood cell labeling method. Our distributor in Canada will be GE Healthcare Medical Diagnostics (formerly Amersham Health) (NYSE: GE)," remarked Cynthia L. Sullivan, President and Chief Executive Officer.

Osteomyelitis is commonly a disease of childhood but adults with lowered immunity and diabetes are also susceptible. Early diagnosis of infection in diabetic patients with foot ulcers is critical, since prompt treatment with antibiotics may decrease the need for amputation. Nuclear Medicine imaging with LeukoScan(R) has been shown to be highly sensitive for detecting osteomyelitis in patients with diabetic foot ulcers, and may also be useful for monitoring the efficacy of antibiotic treatment. LeukoScan(R) works by preferentially binding to activated granulocytes in the blood stream and at the site of infection. Because more activated granulocytes are at the site of infection than in circulation or bone marrow, there is less non-specific activity. The product is sold through distributors in Australia, throughout Europe and the Middle East, with registrations pending in Argentina, India, and Israel.

Immunomedics is a 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 believe that our portfolio of intellectual property, which includes approximately 90 issued patents in the United States, and more than 250 other issued patents worldwide, protects our product candidates and technologies.

This release, in addition to historical information, contains forward- looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements, 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), competitive risks to marketed products and availability of financing and other sources of capital, as well as the risks discussed in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2004. 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.

Company Contact: Chau Cheng, Associate Director, Investor Relations & Business Analysis, (973) 605-8200, extension 123. Visit the Company's web site at immunomedics.com

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