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FISONS' OPTICROM INSPECTION SCHEDULED FOR WEEK OF APRIL 20,

Executive Summary

FISONS' OPTICROM INSPECTION SCHEDULED FOR WEEK OF APRIL 20, the British pharmaceutical firm said April 3. FDA will inspect Fisons' revamped Holmes Chapel, U,.K manufacturing facility for the anti-allergy eye drops. Opticrom (cromolyn sodium) was withdrawn from the U.S. market in July 1990; if FDA clears Fison's upgraded facility, the company will reintroduce the product into the U.S. Fisons earlier had projected a first quarter inspection for both Opticrom and its injectable iron product Imferon, which was withdrawn from the U.S. market in May 1991 ("The Pink Sheet" Jan. 20, T&G-12). Imferon, however, will not be included in the upcoming FDA inspection, Fisons said. "After a full technical review" of Imferon, Fisons said it "has been decided that the FDA should not be asked to audit the Imferon process during their inspection." The company is "currently reviewing the options available...in terms of future [Imferon] supply and will come forward with conclusions and associated action plan as soon as the review is completed." On April 2, Fisons announced a further shift in executive positions with the appointment of Cedric Scroggs as CEO and pharmaceutical division chairman. Scroggs has served as scientific equipment division chairman since 1981. He takes over the CEO duties from John Kerridge, who resigned as chairman and CEO on Jan. 14, and the pharmaceutical division top post from Peter Fothergill, who also has resigned, Fisons said. In announcing the appointment, new Fisons' Chairman Patrick Egan said that Scroggs will be joining a pharmaceutical operation that has been "strengthened by the recruitment" of a number of outside managers. These include Managing Director-Marketing Operations Mike Redmond, who joined from Schering-Plough last year; Director of Technical Operations Bill Clark, who joined from Searle; European Regional Director Brian Tempest, a Glaxo veteran who joined in February; and Director of Quality Assurance David Pendergast, who came on board in March from Upjohn. The outcome of the FDA Opticrom inspection could have a major impact on Fisons' financial fortunes. When the problems uncovered by a 1991 FDA inspection of the Holmes Chapel facility emerged, the company had predicted that "profitability will...return to normality in the second half of the year" from resupply of both Opticrom and Imferon ("The Pink Sheet" Jan. 6, p. 17).
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