MORRIS PLAINS, N.J., April 22 /PRNewswire/ -- Immunomedics, Inc.
(Nasdaq: IMMU) announced today that it has launched LeukoScan(R), its
radiolabeled monoclonal antibody fragment for the detection of infectious disease, in Germany and Austria, with launch in the U.K. and Ireland scheduled for later this week. Initially, distribution of the product within the European Union will be handled by Mallinckrodt Medical, B.V., who also partners with Immunomedics for the sale and distribution of CEA-Scan(R) colorectal cancer imaging agent. LeukoScan which provides a one-step, rapid method of locating sites of infection within the body, received final clearance, from the European Commission in February for sale and marketing in the 15 nations comprising the European Union. The Company expects to begin promoting LeukoScan in the other European countries in the months ahead.
"We are very pleased with the initial market response to LeukoScan, particularly in Germany," said Dr. David M. Goldenberg, Chairman and CEO of Immunomedics. "This product offers a potentially valuable alternative to current methods for imaging infectious disease sites, and its availability has been eagerly anticipated since EC approval," Dr. Goldenberg added.
The approved indication for LeukoScan is the detection and diagnosis of osteomyelitis (bone infection) involving long bones, particularly in diabetic patients with foot ulcers, for which osteomyelitis can be a frequent complication. Coordination of sales and marketing activities for LeukoScan in Europe will be the responsibility of Philippe Barzin, General Manager of Immunomedics, B.V., the Company's European subsidiary located in Petten, The Netherlands. "We are excited by the prospect for this product, the initial orders for which have exceeded our expectations," Mr. Barzin commented. He also said that clinical results of LeukoScan in acute atypical appendicitis were presented at the recent Annual Meeting of the German Society for Nuclear Medicine in Kassel.
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 and antibody fragments designed to deliver radioisotopes and chemotherapeutic agents to tumors and sites of infection. The Company's first product, CEA-Scan(R) for the 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. Its second product, LeukoScan, for the detection of infectious diseases, is currently under review in the United States by the Food and Drug Administration. Immunomedics also has several other diagnostic imaging products and two therapeutic products in clinical trials.
This news release contains forward-looking statements that involve risk and uncertainty. The development and commercialization of the Company's imaging and therapeutic programs and products 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 and marketing, actions of regulatory authorities concerning product approval, actions of government and private organizations concerning reimbursement, the impact of competitive products and pricing, and the results of further clinical trials.
SOURCE Immunomedics, Inc. |
