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ABBOTT ZILEUTON NDA FILING FOR ASTHMA, ULCERATIVE COLITIS PLANNED BY EARLY 1994, COMPANY TELLS NYSSA; CLARITHROMYCIN SALES WILL TOP $200 MIL. IN 1992

Executive Summary

Abbott plans to file an NDA for the anti-inflammatory drug zileuton by early 1994, Abbott Chairman Duane Burnham told the New York Society of Security Analysts Nov. 9. Describing the 5-lipoxygenase inhibitor as having "perhaps the greatest commercial potential" among Abbott pharmaceutical research projects, Burnham said: "If our clinical success continues, we will plan to file NDAs for indications for asthma and ulcerative colitis in either late 1993 or early 1994." Zileuton is also under study for rheumatoid arthritis and psoriasis. Burnham, however, noted that the company is "not talking publicly" about those indications yet. He added that a follow-on compound, A-78773, "looks promising." Other pharmaceutical research projects highlighted by Burnham include: the anti-epileptic tiagabine, licensed from Novo Nordisk; the inhalation anesthetic sevoflurane, licensed from the Japanese firm Maruishi; and the anti-schizophrenic sertinole, licensed from the Danish firm H. Lundbeck. Phase II trials of sertinole indicate that it "appears to have fewer and less severe side effects than other therapies," Burnham said. An IND for tiagabine was filed in April 1991, and the GABA reuptake inhibitor has moved into Phase II. The recently-licensed sevoflurane has not yet begun U.S. trials, Burnham said. Abbott's recently-launched antibiotic Biaxin (clarithromycin) is performing well, Burnham reported. "Worldwide sales will significantly exceed $200 mil. this year," he said. Clarithromycin was launched in the U.S. at the start of the year. Abbott "filed an NDA at the end of October" for a new indication of treatment of Mycobacterium avium complex in people with AIDS, Burnham told the NYSSA. Results of an AIDS Clinical Trials Group study of Biaxin were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in October ("The Pink Sheet" Oct. 19, T&G-11). In August, Abbott filed an NDA for a pediatric form of clarithromycin. "In the U.S., our pediatric nutritional sales force will copromote the product when it is approved," Burnham said. Abbott is "also looking at clarithromycin for the elimination of H. pylori," a bacterium believed to cause gastric ulcers, he added. The lung surfactant Survanta (beractant) "has gained the market leadership position in the U.S.," Burnham declared. Survanta was approved in July 1991, approximately one year after Burroughs Wellcome's Exosurf, for treatment of infant respiratory distress syndrome. "In the past two years we've nearly doubled the size of our domestic sales force," Burnham said. He noted that the sales force hired to detail the antibiotic Omniflox (temafloxacin) was not eliminated when Omniflox was withdrawn from the market in June. Many repos were "redirected to Biaxin" and will be available to support the launch of new products, Burnham said. As part of its sales force expansion, Abbott has strengthened "our sales force directed at the managed care segment," Burnham noted. Commenting on expectations for the pharmaceutical industry during a Clinton Administration and in years ahead, Burnham said Abbott expects to "see an even more constrained market in the U.S." due to a combination of larger group purchasers and "some kind of [government price] controls or restraints." Burnham predicted "some kind of re-emergence" of Sen. Pryor's (D-Ark.) S 2000. However, he maintained, "Abbott has never relied on price increases for reported earnings per share growth." Pryor's proposal would reduce Sec. 936 tax credits to pharmaceutical companies when their product prices increase faster than inflation. According to Abbott's 1991 annual report, domestic pharmaceutical and nutritional sales increased 12% in 1991, "approximately 7% due to net price increases and 5% due to volume growth." Corporate sales, including devices and diagnostics, increased 11.7% in 1991 "due to unit growth of 8.6% and net price increases of 3.2%." Abbott's pharmaceutical business increased by 30% in the first nine months of 1992, Burnham said. In 1991, pharmaceutical sales were $1.31 bil., up 23%.
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