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Executive Summary

SCHEIN LAUNCHING INFED INJECTABLE IRON, the company's first branded product, by the end of September, Schein Chairman Martin Sperber told a Bear Stearns health-care conference in New York City Sept. 12. Infed (iron dextran) is indicated for use in patients needing iron for whom oral iron use is unsatisfactory or impossible. Initial quantities will be small, with full commercial availability expected in October, Schein said. Infed "is vitally needed as a complement to Amgen's Epogen used in kidney dialysis patients," Sperber said, and the company has geared up to sell the product to that market. "In order to meet a very acute emergency medical need expeditiously, we are working very closely with FDA and will be making available our initial production lots later this month on an emergency basis at no charge," Sperber said. Iron supplementation is routinely used with Epogen, and a section of epoetin alfa's labeling is devoted to the need for routine and continuing "iron evaluation" in dialysis patients. Amgen said that its clinical trials for Epogen show that approximately 20% of the 100,000 end-stage renal disease patients on dialysis need intravenous iron. Injectable iron is also routinely reimbursed, Amgen noted, which is not true of all forms of oral iron. Amgen has in place information networks, educational programs, and, when needed, financial assistance to ensure that iron is available to all dialysis patients, the company said. The "medical need" cited by Sperber stems from an interruption in the production of the only other approved injectable iron: Fisons' Imferon. Imferon has been marketed since 1957. Fisons, however, recently has had difficulty manufacturing the product. The company recalled two lots totaling about 37,000 units in July 1990. In December, the company "encountered manufacturing difficulties during the production of Imferon which resulted in the Imferon product failing to meet Fisons' quality assurance standards," the company said in a May 17 letter to its customers. Attempts to correct the problems "have left us with an array of complex issues which still need to be resolved. As a result, the supply of Imferon to the marketplace has stopped and we do not have a projected date of availability," the letter states. Schein's launch of Infed will really be a reintroduction: the company's Steris Labs subsidiary has held an NDA for iron dextran since 1974. The company initially used Fisons as a source for raw materials. Fisons terminated the supply agreement in the mid- 1980s, Schein said, and the firm could no longer market the product without an NDA supplement covering a new source of raw materials. Schein's NDA supplement was approved last month, it said. Amgen plans to spread the word through its sales and marketing organization of the Schein product's pending availability. Schein also has a large sales force for a generics firm, with 100 reps, of whom over 80 are in the field, Sperber noted. They will promote Infed to dialysis centers, nephrologists and hospitals. The company said that it will also seek to expand the market beyond dialysis patients. Schein's large sales force is emblematic of the future of the generic industry, Sperber told the Bear Stearns meeting. Due to consolidation, the industry is entering "a more rational, stable- pricing period," he asserted, and a large sales force will be a prerequisite for success. As an example of the successes possible with focused marketing, Sperber cited Schein's experience with its generic version of Merck's Flexeril (cyclobenzaprine). After a successful patent challenge, Schein had two years as the exclusive generic, beginning in May 1989. After two years, the generic captured 60% of the market, Sperber said, noting that Schein's product now has 65% of the market despite the introduction of a second generic. Another trend in the industry, Sperber said, is towards more prepatent expiry marketing agreements with innovator firms like the one negotiated by Rugby with SmithKline Beecham for Dyazide ("The Pink Sheet" Sept. 3, 1990, p. 3). Schein has "several" such agreements in place, he noted.

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