Immunomedics Inc. on Monday said it has filed its first productlicense application with the Food and Drug Administration. ThePLA is for approval to market an in vivo imaging product,ImmuRAID-CEA, to diagnose and detect colorectal cancer.
ImmuRAID is a monoclonal antibody fragment linked withtechnetium-99, the most frequently used isotope in nuclearmedicine.
The U.S. market for colorectal cancer imaging will be $225million in 1993, according to a report released last month byKemper Securities Group Inc. analyst Mariola B. Haggar. Some150,000 new patients are diagnosed each year with colorectalcancer, and 450,000 additional patients are being treated ormonitored for the disease annually, according toImmunomedics.
Haggar estimated the market for Immunomedics' variousdiagnostic products at more than $1 billion in 1993, with nomore than three or four competitors in any one market. Basedon that, Haggar predicted that the company would break evenin 1994.
Immunomedics has one cancer therapeutic and three imagingproducts for cancers and infectious diseases in Phase I/IIclinical trials.
Common stock of the Warren, N.J., company (NASDAQ:IMMU)closed up $1 at $8.75 on Monday.
Boehringer Ingelheim GmbH of Germany will market several ofImmunomedics' in vivo products in Europe if the companiesreach a definitive agreement on a pact they announced inJanuary. Immunomedics aims to co-market its products in theUnited States, but has yet to find a partner.
The company had a net loss of $2.5 million for the six monthsended Dec. 31 on revenues of $722,000.
-- Karen Bernstein BioWorld Staff
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