A shot across our bow. Who do they think they are dealing with?
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. (Nasdaq: IMMU), together with Mallinckrodt Group Inc. (NYSE: MKG), 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.
CONTACT: Paul M. Herron, Director, Finance, of Immunomedics, Inc., 201-605-8200; or
Barbara A. Abbett, Vice President of Mallinckrodt Group Inc., 314-854-5230 |
