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Executive Summary

LEDERLE SUPRAX SALES MEETING EXPECTATIONS, putting the product in line to become Lederle's top U.S. seller in "a few years," Lederle Labs President David Bethune indicated Oct. 11. Speaking at Pru-Bache Capital Funding's annual health care conference, Bethune said: "We have every reason to believe that, in the next few years, Suprax will become Lederle's number one product in U.S. dollar sales. That would put us probably on the curve of being one of the top two or three antibiotics in terms of adoption of sales," he added. Minocin (minocycline) is the firm's current leader, with U.S. sales estimated at $125 mil. The oral third-generation cephalosporin Suprax (cefixime) was launched in July as a once-daily treatment for otitis media. "Judging by early response, Suprax' performance will be right in line with our expectations," Bethune said. Lederle can quantify its prediction, he added, by "three key measures of success: the awareness of the product among physician prescribers," Suprax' "actual performance, and retail stocking levels." Regarding prescriber awareness, "80% of the nation's pediatricians say that they have heard of Suprax to date. Of those, half have prescribed it," Bethune reported, adding: "Among the general care physicians, 75% report that they've heard of Suprax, while 45% of them have prescribed the product. We were aiming to reach those numbers by November," he noted, "and we're delighted to be well ahead of our schedule." Reporting on another of the firm's measures of success for Suprax, Bethune said that "by early September, Suprax was on 90% of all retail pharmacy shelves in the United States, both independent and chain stores." Suprax is being prescribed in place of Lilly's Ceclor, Glaxo's Ceftin and SmithKline Beecham's Augmentin, Bethune said, noting: "That's exactly the market that we intend to capture. We're extremely pleased with this early reception, especially considering that we're just entering this, as I said, peak antibiotic season." In addition to otitis media, Suprax is used to treat acute adult bronchitis, acute exacerbations of chronic bronchitis, pharyngitis and urinary tract infections. Lederle plans to file a supplemental NDA for sinusitis. By "mid-1990, we will submit another NDA for the indication against gonorrhea," Bethune noted. "In clinical tests, Suprax has been very effective against gonorrhea in a single oral dose," he said. "That makes an attractive and economic alternative to what's currently available." Lederle is also exploring the hospital market for Suprax as a more cost-effective replacement for I.V. antibiotics, Bethune continued. Suprax "has the potential to replace injectable products in the treatment of hospital patients; patients transferred from an I.V. to an oral dose can be discharged perhaps earlier. Thus, Suprax could have a potential cost effective advantage," he maintained. Although Suprax is expected to surpass Minocin as Lederle's sales leader, the American Cyanamid pharmaceutical business is still milking the 18-year old Minocin with new forms and additional indications. In January, Lederle will introduce Minocin pellets, which allow for smoother absorption and are less affected by food, according to Bethune. The company also is developing a once-daily form of the drug, which will be available "in a year or two," he added. Lederle is exploring the drug's use to treat Lyme Disease and will "conduct extensive studies next spring." The company is also looking at the drug for treatment of peritonitis. Clinical studies are underway on a newly-patented powder dosage form that is inserted directly into periodontal pockets and does not have to be removed. Lederle plans to file an NDA on this Minocin product "by early 1991," Bethune said. Bethune said another NDA is planned by mid-1991 for a combination of Lederle's third important antibiotic, Pipracil (piperacillin), and the beta lactamase inhibitor, tazobactam, which the firm licenses from Taiho, Japan. Piperacillin/tazobactam will be positioned as a very broad spectrum parenteral antibiotic monotherapy "with a wide range of uses, including staphylococcal coverage," Bethune noted.

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