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Executive Summary

U.S. sales of Searle's Calan-SR (verapamil, sustained release) shot up $ 65 mil. in 1988 to $ 155 mil. at retail acquisition costs, according to calculations by Pharmaceutical Data Systems. The Calan-SR gain of over 70% in sales almost matched in new dollars the continued growth by the calcium channel blocker class leader, Marion's Cardizem (diltiazem). The Marion product added $ 71 mil. in new retail pharmacy sales during 1988 to reach a total of $ 362 mil. Cardizem remained the third largest retail drug in the U.S. for a second consecutive year (see box below for the PDS 1988 Top Ten Retail Drugs). The total U.S. market for calcium channel blockers in 1988 climbed 26% to reach $ 856 mil., PDS VP Michael Ira Smith reported during a March 10 review of 1988 for New York financial analysts. Cardizem and Calan-SR combined to provide over three-quarters of the new dollars in that market, according to PDS figures. In a mid-February report on its 1988 operating results, Searle's parent Monsanto credited the Calan line -- presumably including oral and I.V. forms -- with growth in excess of 80% and total sales above $ 240 mil. ]EDITORS' NOTE: PDS figures are generally lower than manufacturer figures for drug sales for two reasons: (1) the retail figures do not include sales to hospitals or institutions; and (2) PDS bases its estimates on actually dispensed prescriptions. PDS VP Smith noted that PDS numbers are "always lower because of shelving inventory and pipeline."[ Searle's Calan-SR record is noteworthy as a sign of the marketing vigor that the organization was able to muster after its long new product dry spell. The Searle sales momentum is now being turned to the launch of Cytotec (misoprostol) for prevention of ulcers associated with NSAID use. As part of the early roll-out for that product, Searle is breaking promotional ground with a hospital docu-drama/mini-series running on the Lifetime cable channel (see related T&G this issue). The Calan-SR experience is also important as an indicator of the appeal of a sustained release product in the calcium channel blocker field. Marion is now introducing its twice-daily sustained release version to narrow the dosing gap with Calan-SR and the Knoll brand Isoptin-SR. Knoll has steadily held a sales base of about $ 50 mil. to earn the fourth place position in the calcium channel blocker. Last year, Knoll's Isoptin-SR did $ 51 mil., PDS reports. Pfizer held down second-place in the calcium channel blocker market -- and ninth place among the Top Ten -- with $ 251 mil., by PDS tabulations. Pfizer reports Procardia sales climbed 19% to $ 364 mil. in 1988. As in 1987, five of the Top Ten products are cardiovascular agents: one new product joined the list and a perennial Top Ten product dropped off. Merck's Vasotec was the new entry to the list, jumping into the top PDS group with a 57% sales increase to $ 245 mil. SmithKline's Dyazide slipped off the list from sixth place as generic competition cut $ 78 mil. off of sales. Dyazide finished 1988 with sales of $ 174 mil., PDS said. The dominance of a small cadre of patent-protected products in the overall pharmaceutical industry is becoming increasingly pronounced. Smith observed that "almost one out of five dollars spent in the retail sector (almost 20% of all the dollars) are spent on these ten products." The Top Ten products accounted for $ 3.3 bil. in sales in 1988, PDS said, out of a total of $ 17.8 bil. in retail sales. The amount of sales generated by the top products is "becoming more concentrated year after year," PDS says. In 1987, Smith said, the group accounted for 17% of the total market sales. In 1988, that percentage increased to 18%. Smith pointed out that there are about 70,000 to 80,000 products overall in the U.S. drug business. Merck's newest entry into the Top Ten, Vasotec, is viewed by PDS as the current leader in the ACE (angiotensin converting enzyme inhibitor) category. Squibb's Capoten, however, took the larger share of ACE Rxs and dollars for 1988. PDS put Capoten 1988 sales at $ 273 mil. (up 19%) and its share of ACE Rxs at 44%. The diuretic combo, Capozide, adds another 5% to Squibb's share of ACE Rxs. With both products, Squibb held 49% of the ACE Rxs in 1988, or just over 12 mil. Rxs and 51% of the dollars with $ 299 mil. The three Merck ACE products (Vasotec, Vaseretic and Prinivil) combined to capture 48% of the Rxs in that class in 1988. Stuart's Zestril brand of lisinopril had 3% of the Rxs. Stuart did $ 13 mil. with Zestril in 1988 and Merck $ 12 mil. from Prinivil, according to PDS projections. The ACEs continued to increase their share of the cardiovascular market. The class represented 20% of a $ 3.4 bil. market in 1987 and 23% of the $ 3.7 bil. market in 1988. Beta blockers (25%) and centrally active antihypertensives (12%) each lost three share points in the overall cardiovascular class between 1987 and 1988. PDS does not include diuretics in its definition of the cardiovascular market. PDS is predicting that Merck's Vasotec could be supplanted as that company's top U.S. drug product in the "next year or two" by the anti-cholesterol agent, Mevacor. Prescriptions in the anti-lipemic class almost doubled in 1988 from 6.4 mil. to 11.4 mil. Mevacor added over 3 mil. extra prescriptions in 1988, "exploding the market here," Smith said. Two of the three existing agents in the anti-lipemic category increased dollar volume despite losing share to the Mevacor entry. Warner-Lambert's Lopid jumped to $ 90 mil. in PDS figures from $ 56 mil. the year before and Merrell-Dow's Lorelco climbed to $ 34 mil. from $ 31 mil. Mead Johnson's Questran held steady in dollar sales at about $ 49 mil. PDS estimated Merck's total retail drug business in the U.S. at $ 1.4 bil. in 1988 with three products over $ 100 mil.: Vasotec ($ 245 mil.), Mevacor ($ 181.5 mil.) and Clinoril ($ 151.8 mil.). There have already been at least two ANDA applications approved for generic versions of sulindac (Clinoril) from Danbury and American Therapeutics. FDA has made the approvals in advance of the patient expiration date in early April 1990. PDS' low-side (retail only) figures put Pepcid ($ 93.2 mil.) and Flexeril ($ 88.7 mil.) near the $ 100 mil. mark. With hospital sales and the higher trade sales reported by Merck, those products also presumably passed the $ 100 mil. sales mark in the U.S. in 1989. The hospital product, Mefoxin is also well above the $ 100 mil. milestone at $ 170 mil. PDS figures indicate that Merck had at least a half dozen drug products with sales above $ 100 mil. in the U.S. in 1988. However, PDS did not give figures for Sinemet or Timoptic, which also may be above $ 100 mil. in the U.S. Merck has recently begun to dramatize its breadth of product line worldwide by highlighting the fact that it had 14 human drug products with sales over $ 100 mil. worldwide in 1988 and one animal product, ivermectin. The Flexeril figures show a substantial gain for the product in 1988. PDS said that prescriptions increased 13% for the product to 5.1 mil. Rxs and sales jumped 21%. Flexeril was one of eight products highlighted by PDS as mid-sized "winners" in prescription growth and sales growth in 1988. The three second generation oral antidiabetic products were all in that category: Hoechst's Diabeta had the fastest percentage growth in prescription activity among those products, up 26% to almost 4 mil. Rxs and $ 56 mil. in sales. Roerig's Glucatrol had fewer prescriptions (3.9 mil.) but more dollars ($ 62 mil.), by PDS calculations. Upjohn's Micronase was the category leader: 5.8 mil. Rxs (up 24%) and $ 94 mil. in sales. Chart omitted.

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