Cytogen Corp. and Cetus Corp. on Tuesday said they havereceived European marketing approval for Cytogen's OncoScintCR103, a diagnostic imaging agent for the detection ofcolorectal cancer.
OncoScint, Cytogen's first commercial product, links a tumor-specific monoclonal antibody with the isotope indium-111.OncoScint is the first MAb-based imaging agent to be approvedby the Committee for Proprietary Medicinal Products (CPMP).
About 158,000 new cases of colorectal cancer are diagnosed inEurope each year, and an additional 677,000 previouslydiagnosed patients are monitored. Similar figures apply in theUnited States. Cytogen estimates the total U.S./Europeanmarket for MAb-based imaging of colorectal cancer at $400million.
EuroCetus BV, a subsidiary of Emeryville, Calif.-based Cetus,will market OncoScint in Europe. Following the approval by theEuropean CPMP, individual European countries must nowapprove OncoScint.
Cytogen applied for U.S. marketing approval in 1989. "We'll bevery disappointed if we don't receive approval by the end ofthis calendar year," said George Ebright, chairman and chiefexecutive officer of the Princeton, N.J., company.
Cytogen stock (NASDAQ:CYTO) closed at $15.63, up 25 cents onTuesday. Cetus stock (NASDAQ:CTUS) was up 50 cents to$14.88. -- KB
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