CENTOCOR MANAGEMENT SHAKEUP: EXECUTIVE COMMITTEE IN, WAVLE OUT in a move "redefining corporate strategy" that follows an April 17 FDA announcement that it had asked the biotech firm to perform a second well-controlled clinical trial of its antisepsis monoclonal Centoxin before the agency will resume review of the product's PLA. Announced April 28, the realignment of top management moves Centocor founder and former Chairman Michael Wall into a newly established executive committee with current Chairman and Co-CEO Hubert Schoemaker. President and Co-CEO James Wavle resigned, Centocor announced the day before its annual meeting with shareholders. Diagnostic Division President and corporate Exec VP David Holveck succeeds Wavle as president. A former Warner-Lambert exec, Wavle joined Centocor in 1987. Elizabeth Tallet, who had been president of Centocor's Pharmaceutical Division, also left the company. Commenting on the future, Schoemaker said: "I look forward to working more closely with both Michael Wall and Dave Holveck as Centocor moves to overcome the challenges that confront our company." While not being specific about Centocor's plans, Schoemaker said the company "intends to aggressively pursue several objectives, including the raising of additional capital and the reduction of the company's cash-burn rate through both increased sales and a critical examination of expenses." As of Dec. 31, Centecor had $108.9 mil. in cash and equivalents on hand. The company lost $195 mil. last year, with most of its resources allocated to the approval and marketing of Centoxin, including the creation of a 200-person U.S. sales force. Centoxin is providing some revenues to Centocor following the monoclonal antibody's approval last year in some European countries, where it is marketed by a 75-person sales force. According to its recently-released 1991 annual report, Centocor had $57.5 mil. in Centoxin inventory on hand in the U.S. in anticipation of the product's approval. On April 15, Centocor announced that FDA had determined that the available data for Centoxin was "insufficient evidence of efficacy for approval at this time." Last September, the agency's Vaccines & Related Biological Products Advisory Committee had found the product safe and effective ("The Pink Sheet" Sept. 9, 1991, p. 14) and had recommended Centoxin's approval for presumptive gram-negative bacteremia. "Centocor's claim of efficacy was based on an analysis of a subset of 200 study patients with sepsis ultimately found to have gram-negative bacterial infections in the bloodstream," an FDA statement said. "There was no statistically significant difference in survival between treated and placebo groups 14 days after treatment."
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