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MERCK's NOROXIN IS FIRST OF NEW GENERATION QUINOLINE ANTIBACTERIALS TO REACH MARKET; MERCK SIMULTANEOUSLY LAUNCHING PEPCID, NOROXIN WEEK OF NOV. 10-14

Executive Summary

Merck's Noroxin (norfloxacin) will be the first of a new generation of quinoline derivative anti-infectives to reach the market. FDA approved the drug on Nov. 3. Roll-out for Noroxin is scheduled for the week of Nov. 10-14 with national distribution targeted by Nov. 18. The Noroxin market introduction will be simultaneous with Merck's launch of its new one-a-day H[2] antagonist Pepcid (famotidine), approved Oct. 15. The products will be handled by separate sales groups: Noroxin will be detailed by Merck's CID (cardiovascular and infectious disease) sales force; Pepcid will be marketed by Merck's MS (musculoskeletal) sales group. In addition to Noroxin, Merck also received approval from FDA for Vaseretic (enalapril/hydrochlorothiazide) on Nov. 3. Merck said it will postpone launching Vaseretic until the first quarter of 1987. According to the approved labeling, Noroxin is indicated for the "treatment of adults with complicated and uncomplicated urinary tract infections caused by susceptible strains of micro-organisms." The product is priced to wholesalers at $30.45 for bottles of 20, $150 for bottles of 100, and $152.75 for unit dose 100s. The recommended dose is 400 mg b.i.d. with a treatment schedule for uncomplicated urinary tract infections of 7-10 days, and for complicated urinary tract infections, 10-21 days. The maximum daily dose is set at 800 mg per day. Merck's Cardiovascular/Infectious Disease Sales Group Is Handling Five New Product Launches Approved initially for urinary tract infections only, Noroxin is currently in clinicals for additional indications, including the treatment of gastrointestinal infections, diarrhea, gonorrhea, and prevention of infections in patients with low blood cell count. Merck licenses the product from the Japanese firm Kyorin Pharmaceutical. Merck said that Noroxin is marketed in "almost all major counties abroad." Other quinoline products close behind Noroxin include Miles' ciprofloxacin, Sterling's Eradacil, and Warner-Lambert's enoxacin. Sterling has an NDA pending for Eradacil and Warner-Lambert recently filed an NDA for enoxacin in October. The approvals of Noroxin and Vaseretic give Merck the task of engineering four product launches in approximately four months, barring further approvals, while sustaining the sales momentum from its two major launches -- Vasotec and Primaxin -- earlier this year. Five of Merck's six new products fall into the company's CID detail force, including Vasotec, Vaseretic, Primaxin, Noroxin, and Recombivax HB, while the MS sales force is getting only Pepcid. At a recent analyst meeting, Merck Chairman Roy Vagelos said that the company is "not committed to stay" with its split sales force if one side is underutilized. However, he noted that Merck is "very much in favor of a very highly expert group that has deep knowledge in the field." Vaseretic is being put on the back burner until after the launches of Noroxin, Pepcid, and Recombivax HB (scheduled for January) are completed. The combination product will compete with Squibb's ACE inhibitor/diuretic combination product Capozide, which was launched last January, and beta blocker/diuretic combos.
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