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FISONS PROJECTS TILADE APPROVAL AND FOLLOW-UP INSPECTIONS

Executive Summary

FISONS PROJECTS TILADE APPROVAL AND FOLLOW-UP INSPECTIONS for the company's Opticrom and Imferon production facilities in the U.K. within the first quarter of the calendar year. The inspection of the facilities, located in Holmes Chapel, U.K., by both FDA and British health authorities would clear the way for the reintroduction of Opticrom (cromolyn sodium) eyedrops and Imferon injectable iron, which have been unavailable in the U.S. since July 1990 and May 1991, respectively. On Dec. 30, Fisons said the inspections by FDA of its Opticrom production process and of the new water purification system used to produce Imferon would take place in January ("The Pink Sheet" Jan. 6, p. 17). While the company now indicates that the inspections will not take place this month, the firm is said to have received assurances from FDA that the two inspections will begin "no later" than March. In addition to the FDA inspections, Fisons predicts that inspections by British health authorities will also be finished by that time. Fisons also said Jan. 17 that it expects the Tilade (nedocromil) inhaler will be approved by FDA imminently. Tilade was recommended for approval in the treatment of asthma by a vote of five to one at FDA's Pulmonary-Allergy Drugs Advisory Committee meeting in June 1990 ("The Pink Sheet" June 18, 1990, p. 10). The committee's support for Tilade was tepid, however, due to efficacy data that most of the advisory committee found to be not entirely conclusive. The fallout from Fisons' inspection records at the Holmes Chapel facility continued on Jan. 14 with the announcement of the resignation of Fisons Chairman and CEO John Kerridge. His departure resulted, in part, from the stress related to the company's recent regulatory difficulties. The official word from Fisons was that Kerridge, 57, resigned "on the grounds of ill-health" after serving 11 years as CEO and seven years as chairman. Kerridge suffers from a heart problem that "was probably exacerbated" by recent events, a spokesperson observed. Succeeding Kerridge as chairman is Patrick Egan, a Unilever exec. Egan, 61, has been a non-executive director of Fisons for the past six years. The company plans "in due course" to name a chief executive officer, after which Egan will become non- executive chairman of Fisons plc. Egan will retire from Unilever in May after 42 years; he is a main board director of Unilever plc and NV and was director of international operations of the Anglo/Dutch firm. Fisons describes Egan as a "hands-on director" who is expected to bring a "more open style of management" to Fisons than that of his predecessor. In a statement announcing Kerridge's resignation, Egan said: "The Board wishes it to be clearly understood that there has been no pressure on Mr. Kerridge either from his fellow board members or from our principal institutional shareholders, for him to take this course of action; the decision is a medical one and entirely his own." During Kerridge's tenure, sales rose from (British pound)494 mil. in 1981 to (British Pound)1.2 bil. in 1990; pre-tax profits increased from (British Pound)9.2 mil. in 1981 to (British pound)230.2 a decade later. Fisons latest round of difficulties began when the company announced Dec. 11 that profits would be down by approximately $117 mil. ((British Pound)65 mil.) in 1991 as a result of the continued absence of Opticrom and Imferon from the U.S. market, as well as the cost of upgrading the Holmes Chapel facility to meet FDA standards ("The Pink Sheet" Dec. 23, p. 8).

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