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Executive Summary

Wyeth-Ayerst's Lodine (etodolac) was the number one new prescription drug product in the U.S. market in 1991, according to retail market data collected by Pharmaceutical Data Services in its 1991 Pharmaceutical Industry Year End Review. In a March 27 presentation in New York City, PDS VP-Marketing & Product Development Patrick Miller, PhD, said that only five new products made a significant impact in 1991. Following Lodine are: Ortho's Floxin (ofloxacin), Sandoz' DynaCirc (isradipine), Abbott's ProSom (estazolam) and Roerig's Cardura (doxazosin). Overall, "1991 was not a good year for new products," Miller said. Although sales of new drugs were not exemplary, the number of FDA approvals in recent years has been high. FDA's performance in approving 30 new molecular entities tied the record set in 1985 for the most NMEs approved by the agency in one year ("The Pink Sheet" Jan. 6, p. 13). The previous year lagged behind with 23 approvals, the same number as in 1989 ("The Pink Sheet" Jan. 7, 1991, p. 9). Among 1991 approvals, only five drugs were classified as "1A" (important therapeutic gain). Four of them, including Genzyme's Ceredase, Berlex' Fludara, Parke-Davis' Nipent, and R.W. Johnson's Supprelin target diseases such as Type 1 Gaucher's disease and chronic lymphocytic leukemia, which have small patient bases. All five new drugs mentioned by Miller were approved by FDA with a classification of "1C" (little or not therapeutic gain). Approved on Jan. 31, 1991, Lodine generated Rx volume of over 200,000 in its fourth month on the market, Miller said. The product's success is attributable at least in part to its positioning in an "unsatisfied market," he suggested. Lodine's labeling includes data from studies showing that the drug causes fewer GI lesions than other NSAIDs. While Lodine ads do not explicitly claim that the product is "easier for the GI (gastrointestinal) tract," that perception "may help drive" Lodine sales, Miller said. The labeling for another recent entrant in the NSAID category, SmithKline Beecham's Relafen, includes data showing a lower incidence of peptic ulcers than other NSAIDs ("The Pink Sheet" Jan. 6, p. 5). However, when FDA approved Relafen, it told the company it would have to conduct a study of peptic ulcer, perforation and bleed in order to make a claim of lower incidence of side effects. Currently, NSAIDs "are generating tremendous volume," Miller said, but with the imminent patent expirations for Syntex' Naprosyn (naproxen) -- exclusivity ends Dec. 21, 1993 -- and Pfizer's Feldene (piroxicam) -- exclusivity ends in April 1992 -- "1992 may be the last worthwhile year for sales in the NSAID category." Miller speculated that Lodine and Relafen will not make a "great deal of difference," and noted that NSAID successors are "still far back in the pipeline." In an analysis of the overall volume growth of prescription drugs in 1991, Miller pointed out that "all of that growth came in the area of new prescriptions. Refill prescriptions for the second year in a row declined." With physicians writing fewer refills, Miller explained, "brand choices are being made more often." This trend is significant in categories such as NSAIDs, hypertension and other chronic diseases "where companies have often viewed patients as annuities," Miller said. It also gives newcomers "more and more opportunities to break into the prescribing cycle." Miller noted that the 10 drugs with the highest prescription volume "have been around for a long time." There "aren't any glamour products" in the top 10 list, he said. Codeine was the most frequently prescribed drug in the U.S. in 1991, with 64.9 mil. Rxs written, up 3.7%. NSAIDs followed with a prescription volume for the category of over 61 mil., down .8% since 1990. Amoxicillin was third, with prescription volume growing 14.5% for the year to 58 mil. The highest revenue-producing category was anti-ulcer drugs, with U.S. sales of $1.8 bil. in 1991. Calcium channel blockers ranked second at $1.5 bil., and NSAIDs were third with sales of $1.3 bil. Angiotensin-converting enzyme (ACE) inhibitors generated total sales of $910 mil., the fifth largest category. Four of the top 10 revenue producing categories are centered in the broad cardiovascular area. "Many of these large categories," Miller said, "are also hotbeds of new products and high science activity." Cholesterol reducers, with sales of $822 mil., showed the most growth, up 26.7% from 1990. Pfizer's Procardia (nifedipine) and Procardia XL helped to drive calcium channel blocker sales as a group up 18.1%. U.S. sales for the Procardia family of products advanced 24% in 1991 to $510 mil., pushing the product line into the number two position for dollar volume. Glaxo's Zantac remained the number one product, with U.S. sales of $916 mil. Miller characterized the acceptance of Procardia XL as a "real tribute to Pfizer" for its "largely successful" efforts to offset "generic inroads in the category." The once-a-day calcium channel blocker was approved in 1989. The marketing exclusivity for Procardia XL expires on Sept. 6 of this year ("The Pink Sheet, Feb. 17, p. 7). Miller attributed the rapid advance of calcium channel blockers and ACE inhibitors to the trend of "prescribers moving away from the traditional step-care approach treatment of hypertension." Beta blockers experienced a 3% loss in prescription volume, Miller said, because prescribers "are starting with calcium channel blockers and ACE inhibitors." Sandoz' new calcium channel blocker DynaCirc was the third most successful new product in 1991 with volume prescriptions of 50,000 during its fourth month on the market. According to Miller, DynaCirc "is not an outstanding product," and has done well "primarily because the calcium channel blocker market is so large and any reasonably early entry will do well." DynaCirc received FDA approval on Dec. 24, 1990, five years after Sandoz filed the NDA. The drug joined Syntex' Cardene (nicardipine) and Miles' Nimotop (nimodipine) as the third of the second-generation calcium channel blockers ("The Pink Sheet" Dec. 24, 1990, T&G-1). Sandoz originally planned to copromote DynaCirc with Glaxo until a nonprescription version of rantidine (Zantac) is approved. At that time Sandoz would have transferred ownership of DynaCirc to Glaxo. Under a restructured agreement, Glaxo will stop copromoting the drug in 1993 ("The Pink Sheet" Dec. 23, p. 6). Sandoz has an NDA pending for a once-a-day version of DynaCirc.

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