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SELDANE U.S. VOLUME SURPASSES $90 MIL. IN 1986, MAKES UP 25% OF MERRELL DOW's DOMESTIC DRUG SALES: FIRM PLANS TO SEEK OTC STATUS FOR "SOME FORMS" IN FUTURE

Executive Summary

Merrell Dow's nonsedating antihistamine Seldane (terfenadine) sales topped $90 mil. in 1986, the product's second year on the market, the company reported to security analysts Jan. 14-15. The product accounted for roughly one quarter of the firm's estimated $375 mil. 1986 U.S. pharmaceutical business. Helped by 30% or more sales increases by the anti-depressant Norpramin and the cholesterol-lowering agent Lorelco, U.S. drug volume was up 38% for the year. "Within four weeks after launch (in May 1985), Seldane was the number one prescribed single-entity antihistamine in the U.S. and within eight weeks, the number one prescribed allergy product of any kind in the U.S.," Merrell Dow Exec VP James Buzard, PhD, noted. Merrell hopes to capitalize further on the antihistamine's success as an Rx product, with the planned switch to OTC of "some forms" of Seldane in the future. Buzard highlighted compounds emerging from the Merrell Dow R&D pipeline, focusing on three drugs that have reached Phase III development. Sabril (vigabatrin), an anticonvulsant, is under study as adjuvant therapy for patients with refractory epilepsy. Presenting results to date, the company said that of approximately 700 patients receiving the drug along with existing therapy, about half showed at least a 50% reduction in the frequency of seizures. Buzard reported that Merrell Dow "is negotiating with FDA for further clinical study in the U.S." The oral inotropic agent enoximone, another Phase III drug, is being studied for treatment of congestive heart failure. "Based upon the encouraging results of studies over the past two years," Buzard said, "current studies of oral enoximone are focusing on Class II and III congestive heart failure patients at lower doses, including assessments of quality of life. These trials are also comparing enoximone to the ACE inhibitor captopril." He added that an NDA for the I.V. form was submitted to FDA in May 1986. A third developmental compound is the glycopeptide antibiotic Targocid (teicoplanin). The drug is specified for gram positive bacteria and is active against methacillin resistant strains, according to the company. Buzard said that Phase III studies with the once-a-day injectable have been completed in over 2,000 patients for use against skin and soft tissue infections, endocarditis, osteomylitis and as a prophylactic in surgical procedures. To accommodate the anticipated addition of new Rx and OTC products, as well as to better market existing products, the company noted it has built up its total sales force to almost 700 reps, an increase of 21% in less than two years. At the time of its decision to augment its detail force, the company created two separate sales forces -- Merrell Dow and Lakeside Pharmaceuticals -- to concentrate on Rx and OTC products, respectively. Pointing out that the 21% increase in field sales personnel has resulted in a 29% increase in physician and retail calls, Merrell Dow President David Sharrock commented: "Our two sales forces have and will enable us to launch more new products . . . while continuing to grow existing brands." Currently, Merrell's seven-year plan calls for a more than two-fold increase in worldwide drug sales, from $920 mil. in 1986 to $2.2 bil. in 1993.

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