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Friday October 4 9:53 AM EDT
Colorectal Cancer Detection Agent Cleared For Sale In Europe
Immunomedics And Mallinckrodt Announce European Commission Approval For
Cea-Scan (Arcitumomab)
MORRIS PLAINS, N.J., and ST. LOUIS, Oct. 4 /PRNewswire/ -- Immunomedics Inc
, together with Mallinckrodt Group Inc , today announced final clearance has
been received from the European Commission ("EC") to market CEA-Scan(R)
(Arcitumomab). This clearance allows the product to be marketed for
colorectal cancer detection in all 15 countries comprising the European
Union. The product is already licensed for use in the U.S.
Colorectal cancer is the third leading cancer killer in the Western World.
Each year there are approximately 175,000 new cases of colorectal cancer in
Europe and the disease is estimated to kill over 100,000 Europeans annually.
"We are excited to move ahead with our strategy of selling this product on
both sides of the Atlantic," said Dr. David M. Goldenberg, chairman of
Immunomedics, Inc. "We look forward to combining our efforts with
Mallinckrodt to seize the opportunity we believe exists for this unique
cancer imaging agent."
The product provides additional information in patients with no evidence of
disease by standard diagnostic methods currently available, and in whom
there is a suspicion of cancer recurrence or spread. "By identifying about
40% more patients who are operable for potential cure, CEA-Scan may offer
hope to some patients. Moreover, by identifying about twice as many patients
for whom surgical removal would be fruitless, these patients will not be
operated on, will not suffer the effects of surgery, and the health care
system will not have to bear the cost," stated Philippe Barzin, General
Manager of Immunomedics B.V., the Company's European subsidiary located in
Petten, The Netherlands.
David Morra, president of the Nuclear Medicine Division of Mallinckrodt
Group, said, "We share Immunomedics' excitement over the clearance of
CEA-Scan in Europe, and we are eager to launch and market the product
throughout Europe. Oncology is a significant area of focus for
Mallinckrodt's nuclear medicine division, and CEA-Scan is an important
addition to our product portfolio in the United States and Europe."
Mallinckrodt is a dynamic, international growth company serving specialty
markets in human healthcare and chemicals. Dedicated to improving healthcare
and chemistry, the company is a major producer of diagnostic imaging agents,
medical devices, pain relief pharmaceuticals, catalysts, and laboratory and
microelectronic chemicals. The St. Louis, Missouri-based company, with
fiscal 1996 net sales of $2.2 billion, sells more than 2,000 products in
more than 100 countries. Mallinckrodt employs about 10,400 people worldwide.
The Mallinckrodt web site address is www.mallinckrodt.com.
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 infectious disease
imaging agent, LeukoScan(R), is undergoing regulatory review in Europe for
imaging osteomyelitis (bone infections), and an application is being
prepared for filing with the FDA. 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. SOURCE
Immunomedics, Inc. |
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