Centocor Inc. said Panorex, an anti-cancer drug being developed incollaboration with Wellcome plc, has been approved in Germany asan adjuvant therapy for post-operative treatment of colorectal cancer.
The regulatory approval is the first for Panorex and the second drugdeveloped by Malvern, Pa.-based Centocor to reach the market. Latelast month, the FDA and the European Union's Committee forProprietary Medicinal Products approved ReoPro, an anti-bloodclotting drug, for use in high risk angioplasty patients.
Panorex, a monoclonal antibody, is designed to kill tumor cells. InGermany, the drug has been approved following surgery for Dukes'C colorectal cancer. In clinical studies, five-year follow-up data on189 patients who received the drug showed that Panorex reduced thedeath rate by 30 percent and decreased the cancer recurrence rate by27 percent.
Under the agreement with London-based Wellcome plc, Centocorwill manufacture Panorex and Wellcome will distribute it. Wellcomesaid it expects to begin selling Panorex in Germany in the next fewmonths.
Timothy Cost, Centocor's senior vice president for strategicoperations, said Panorex also has been submitted for approval inAustria, Finland and Sweden. In addition, the company expects tobegin Phase III trials elsewhere in Europe, Japan and the U.S. earlythis year. Those studies, Cost said, will examine Panorex'seffectiveness beyond the narrow use defined in the German approval.
Centocor has not released details of the protocol to be followed inthe Phase III trials. But Cost said investigators will be looking atpotential uses of Panorex as an adjuvant therapy at different stages ofsurgery for colorectal cancer and as a treatment for other kinds ofcancers. Panorex targets an antigen expressed in breast, lung andovarian cancers as well as colorectal cancer.
Centocor's stock (NASDAQ:CNTO) closed Wednesday at $17, up81 cents. Wellcome (NYSE:WEL) was down 12 cents to $10.62. n
-- Charles Craig
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