If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  LeukoScan Recommended For European Approval MORRIS PLAINS, N.J., Oct. 16, 1996 -- Immunomedics, Inc. (Nasdaq: IMMU) today announced that the Committee for Proprietary Medicinal Products (CPMP) unanimously rendered a positive opinion for the approval of LeukoScan(R), the Company's diagnostic imaging product for detecting sites of infection or inflammation, to the European Agency for the Evaluation of Medicinal Products (EMEA). This recommendation is the final regulatory step before authorization is granted by the European Commission for marketing the product in the 15 nations comprising the European Union. The Company plans to file for FDA approval of LeukoScan for use in patients with bone infection or with atypical appendicitis, a second indication, in the near future, and is currently negotiating with potential partners for marketing the product in Europe and the U.S., if or when approved. The indication considered for LeukoScan was the detection and diagnosis of osteomyelitis (bone infection), involving the long bones and, in particular, osteomyelitis in diabetic patients with foot ulcers. 0steomyelitis can be a frequent complication of diabetes. "This is our second product to receive a favorable review by Europe's central regulatory agency in less than six months," commented Immunomedics' Chairman and CEO, Dr. David M. Goldenberg. "We are particularly pleased that the CPMP opinion would permit multiple use in patients with no measurable levels of an immune response to the product, and we believe LeukoScan may potentially replace tests which have risks for infection due to the necessity of handling patients' blood." LeukoScan is a small antibody fragment (Fab') which reacts with a class of white blood cells (WBC) that accumulate at sites of infection or inflammation. Use of this product does not require the handling of a patient's blood. After being labeled with technetium-99m by a proprietary, convenient method, the targeting agent can reveal sites of infection as early as one hour after injection by using a conventional nuclear camera. The same principle of labeling a small antibody fragment with this common radioisotope is the basis of the Company's entire radiopharmaceutical imaging product line. This same-day, targeting method for rapid diagnosis uses an agent that has not shown an immune response in more than 300 patients tested, distinguishing this product and the Company's technology from most other monoclonal antibody imaging products. Immunomedics is a biopharmaceutical company focused on the development, manufacture and commercialization of diagnostic imaging and therapeutic 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 infection or other diseases. The Company's first product, CEA-Scan(R) for detection of colorectal cancer, has been approved in both the U.S. and Europe and is being marketed by Mallinckrodt Group, Inc. and its European affiliate, Mallinckrodt Medical B.V. Immunomedics also has several other diagnostic imaging products and a therapeutic product in clinical trials. This news release contains forward-looking statements that involve risk and uncertainties. The development of the Company's imaging and therapeutic programs may differ materially from the Company's expectations. Among the factors that could result in a materially different outcome are the inherent uncertainties accompanying new product development, actions of regulatory authorities, and the results of further clinical trials.
|
