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Executive Summary

Lederle/Mylan Maxzide early prescription trends suggest that Lederle can successfully position the diuretic as a branded product distinct from SmithKline's Dyazide,(END ITALICS) American Cyanamid Exec VP-Medical & Consumer Products Jack Bowman told a Dec. 6 analyst meeting in NYC. Bowman said that "for comparison purposes," Lederle is measuring the prescription record of Maxzide against Moduretic, Merck's potassium sparing diuretic agent introduced two years ago. "During the first three weeks on the market Maxzide got a little more than twice as many prescriptions as Moduretic received in its first three weeks of promotion." Acknowledging that the eventual success of Maxzide cannot be measured on three weeks of experience, Bowman maintained that the evidence is enough "to suggest that Maxzide, which is in the same generic class as Dyazide, has the potential to compete as a branded product generating prescriptions in its own name." Lederle is marketing Maxzide aggressively, Bowman said, noting that "we have asked every one of our more than 700-member detail force to concentrate on informing doctors about Maxzide." In promotional literature, the firm is touting Maxzide's approved once-daily labeling and superior bioavailability to the SmithKline formulation of triamterene/hydrochlorothiazide. At an introductory medical symposium for Maxzide on Dec. 5, Lederle maintained that "studies have shown that one Maxzide tablet delivers the optimal administered dose of triamterene and hydrochlorothiazide into the bloodstream while two capsules of Dyazide deliver approximately one-half of the administered dose." Lederle highlighted the patent protection on the manufacturing process for Maxzide, calling it a "unique parallel granulation manufacturing process." The company said the active ingredients "are combined only at the final manufacturing step," and further maintained that "the components of Dyazide are not manufactured in this way and their bioavailability has been shown to be less predictable." The patent runs to 2001, Lederle pointed out. SmithKline is fighting the Maxzide cost advantage claim by stressing that Dyazide is heavily used on a once-daily dosage schedule. At that level of use, it is priced less than Maxzide. In a communication to its sales force, according to an analysis of Dyazide dosing during the last week of June by Pharmaceutical Data Services, SmithKline said that 71% of 14,000 scripts that week were for one capsule a day. Asked by an analyst to predict the first year performance by Maxzide, Bowman said that in 1985 "we think it is pretty realistic to talk of 5 to 10% of the $600 mil. diuretic market." The eventual potential for Maxzide, he added, is "past the $100 mil. level." Using Stuart's beta blocker Tenormin and Merck's Aldomet as examples, Bowman said that like those cardiovascular products, Maxzide's growth curve will likely be gradual but sustained. The market share, he added, will be comprised both of former Dyazide patients as well as those formerly receiving a single ingredient diuretic and a potassium supplement. In the antibiotics area, Bowman said that Lederle is expediting the clinical development of what would be the first oral third generation cephalosporin, a product licensed from Fujisawa of Japan. "We are placing a major effort behind these test trials in order to be able to file a new drug application with the FDA by late next year, with possible introduction early in 1987. Because we are pushing clinical development at such a rapid pace, the product will be the first third generation oral cephalosporin available in the U.S., and this should give us a significant advantage over other third generation products which might follow." The company is in Phase II clinicals with another injectable cephalosporin which Bowman said differs from other third generation products in that it is "quite active against gram positive organisms as well as the usual assortment of gram negative pathogens." Commenting on currently marketed antibiotics, Bowman said that Minocin (minoxcycline) and Pipracil (piperacillin) were "largely responsible for the growth in medical sales both in the U.S. and in internatl. markets." Pipracil, he noted, recently was approved by FDA for the added indication of surgical prophylaxis, making it more attractive to obstetricians and gyncologists. An NDA for Novantrone, a major anticancer development project, is currently being reviewed by FDA, and Bowman said that "we hope to gain approval sometime in 1985." The drug is already being marketed in Canada, the U.K. and South Africa. Bowman said, sales in the three countries in the first year "exceeded initial expectations." Lederle has completed a new production facility for Novantrone at Gosport, England, Bowman declared. He said that approximately 35% of UK breast cancer patients are being treated with Novantrone, and about 25% of breast cancer patients in Canada are receiving the drug. Also in the cancer area, Bowman said that Lederle has "moved to introduce several generic anticancer products next year, and our special oncology field detail force has been further strengthened." Bowman also pointed out that methotrexate, the firm's major current anticancer agent, "has shown efficacy at low dosages in the treatment of rheumatoid arthritis, and a new drug application is expected to be filed with FDA for this use in the first quarter of 1985."

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