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Executive Summary

SmithKline's cardiovascular drug sales of $359 mil. in 1986, led by Dyazide (triamterene/hydrochlorothiazide), surpassed the company's own projections made late in the year, SmithKline indicated in its just-released 1986 annual report. SmithKline's near $360 mil. in worldwide cardiovascular sales, made up predominantly of the company's Dyazide business in the U.S., represents a 15% annual gain. Making a much smaller contribution to cardiovascular group sales are SmithKline's two other Rx heart drugs -- Dyrenium (triamterene) and Dibenzyline (phenoxybenzamine). At the company's December biennial analysts meeting, SmithKline predicted that Dyazide sales in the U.S. would grow about 6% to $310 mil.; however, better than expected fourth quarter results pushed Dyazide sales into the "$320 mil. range," SmithKline said. The company is proceding with development of a reformulated, more bioavailable triamterene/hydrochlorothiazide product, the annual report notes. SmithKline said it will complete ongoing clinical studies of a modified Dyazide product and submit an NDA "in late 1987 or early 1988" -- which is roughly on schedule with earlier company predictions calling for FDA submission this year. SmithKline's cardiovascular business should also benefit from a number of new products emerging from the pipeline. The company said it intends to file NDAs within the next two years for four late-stage cardiovascular products. They include: the vasodilator/beta blocker carvedilol; recently licensed from Boehringer Mannheim; inotropic agents ibopamine and fenoldapam; and a second generation TPA product. As predicted, Tagamet sales topped $1 bil. worldwide in 1986, according to the annual report. Pharmaceutical Data Services estimates Tagamet U.S. retail sales (at pharmacy acquisition cost) at $419 mil., up 5.3% for last year. Based on a decline in new Rxs for Tagamet, PDS has predicted that Zantac will likely surpass Tagamet in U.S. sales this year. SmithKline, however, asserts that the decline in new Rxs is due to increased acceptance of its 800 mg h.s. dosage form. The annual report notes that Rxs for the one-a-day 800 mg dose "account for more days of therapy and therefore more sales dollars. If a unit is defined as a day of treatment, then Tagamet units were up in 1986." Partly to maintain Tagamet market share, SmithKline announced plans in November 1985 to expand and reorganize its sales force, splitting it along chronic care and acute-care lines. The annual report points out that expansion will push the SK&F detail force during 1987 over the 1,000 person level -- up from approximately 750 as recently as a year ago. The focus of a part of its sales force on hospital and acute-care Rx products stands to benefit SmithKline's antibiotic business. The company's cephalosporin sales in the U.S. grew 12% last year to $145 mil. Asserting that Cefizox and Monocid have cost advantages over competing therapies, SmithKline predicted continued "steady growth" from anti-infectives. "Cefizox can replace broad spectrum cephalosporin antibiotics and save about 30% in drug and administration costs for the average 400-bed hospital," the annual report states. Bucking a trend among other brand name drug manufacturers, SmithKline announced last November that it was getting out of the generics business. Like Pfizer, which discontinued its Pfipharmecs operations last July, SmithKline decided to drop its SK-Line "to focus full attention" on its "primary business -- the development and marketing of innovative pharmaceuticals."

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