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Some observers at the Society of Nuclear Medicine meeting in Cincinnatilast month were hopeful that the first monoclonal antibody imagingagents might receive Food and Drug Administration approval thissummer. Hope is becoming reality more quickly in
Some observers at the Society of Nuclear Medicine meeting in Cincinnatilast month were hopeful that the first monoclonal antibody imagingagents might receive Food and Drug Administration approval thissummer. Hope is becoming reality more quickly in Europe, however.
Cytogen became the first monoclonal company to receive a recommendationof approval for a cancer imaging agent from the Committee forProprietary Medicinal Products of the European Community lastmonth. News of the endorsement for OncoScint CR103, a colorectalagent, came in as the SNM meeting was in progress.
The Princeton, NJ, firm hopes to have its first European nationalapprovals within 60 days, said George W. Ebright, chairman andCEO. EuroCetus, Cytogen's European marketing partner, is guidingthe agent through the process. The CPMP go-ahead for the agenttook 15 months to achieve.
Centocor is the only other firm with a monoclonal antibodyimaging agent approved in Europe. Myoscint, a cardiac imagingagent, received CPMP and subsequent national approvals two yearsago (SCAN 6/21/89).
Although no monoclonal imaging agents have been approved bythe Food and Drug Administration, the CPMP move may help expeditethat process, Ebright said.
"This (the CPMP) is a group of major importance that hassaid, We approve this product. That can only be interpreted ascomforting news for the FDA," he said. Although OncoScintis being tested at European clinical sites, the CPMP applicationwas based on U.S. clinical results.
Cytogen signed a letter of intent with the U.S. arm of Germany'sKnoll AG to co-market the firm's colorectal and ovarian imagingagents in the U.S. when those products are approved. The smallerfirm is intent on developing its own sales force, however, andhas maintained sole U.S. marketing rights for most of its agents.
Although Kodak owns marketing rights for Cytogen therapeuticagents targeting colorectal, lung and breast cancer, the biotechnologyfirm has kept control of the U.S. marketing rights for both therapeuticand imaging applications of other agents. Cytogen has maintainedrights to therapeutic applications of its ovarian cancer agentand has full control of a prostate-targeted product that willstart therapy trials this year, Ebright said.
Progress has been slowest for Cytogen in Japan. Potential Japanesepartners have proved reluctant to jump into an untested market,he said.
"Frankly, we are a little disappointed that we have notbeen able to find a suitable Japanese partner," Ebright said.
Progress in Europe may help to convince the recalcitrant Japanese,however.
"Those we have talked to (in Japan) are interested inseeing approval in other key areas. The CPMP approval will certainlyhelp us in discussions with possible Japanese partners" hesaid.