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Executive Summary

CENTOCOR WITHDRAWING MYOSCINT AND FIBRISCINT PLAs following the discovery of "deficiencies" in the applications, the company announced May 28. The deficiencies were found by the law firm King & Spalding, which has been conducting audits of Centocor's PLAs. Centocor declined to elaborate on the nature of the deficiencies. The audits were initiated in the summer of 1992 after FDA determined that protocol changes during Centocor's first Phase III trial for Centoxin, its antisepsis monoclonal antibody, had compromised the data. In March, Centocor scrapped a second Phase III trial of Centoxin, which was stopped in January due to excess deaths in Centoxin-treated patients without gram-negative bacteremia ("The Pink Sheet" March 22, T&G-11). The firm is evaluating clinical parameters and tests for measuring endotoxemia to better identify patients who could benefit from the product. The original PLA for Myoscint, a monoclonal antibody-based cardiac imaging agent, was filed in 1988, and the PLA for Fibriscint, a MAb-based blood-clot imaging agent, was filed in December 1991. Myoscint received an approval recommendation from an FDA advisory committee in November 1991. "With the concurrence of the FDA, Centocor intends to re- analyze the already available data relating to Myoscint...and submit a revised application," Centocor said May 28. The firm hopes to resubmit a PLA for Myoscint this year. "Additional clinical testing will be necessary to support any new application for Fibriscint," the company said. Centocor said its goal is to submit a PLA for its MAb-based platelet aggregation inhibitor CentoRx (7E3) in the third quarter of this year. The PLA will be based on the results from a 56- center study showing that CentoRx reduces by 35% heart attacks and repeat angioplasty on an emergency basis in patients following balloon angioplasty. The study was presented at the American College of Cardiology annual meeting in March ("The Pink Sheet" March 22, T&G-11). Enrollment has begun for Phase III European trials of CentoRx in treating refractory unstable angina in patients scheduled for angioplasty. The enrollment target is 1,400 patients.

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