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WARNER-LAMBERT BUILDING ANTICHOLESTEROL LINE WITH MODIFIED-RELEASE GEMFIBROZIL IN PHASE III, THREE COMPOUNDS MOVING INTO EARLY CLINICALS

Executive Summary

Warner-Lambert is looking to expand its $300 mil. Lopid (gemfibrozil) franchise in the anticholesterol area with three new cholesterol-lowering compounds and a once-daily form of gemfibrozil. An IND was submitted in September for the first of three cholesterol-lowering compounds, an ACAT inhibitor, and clinicals on anotehr ACAT inhibitor will begin before year-end, Pharmaceutical Research Division Chairman Ronald Cresswell, PhD, told Prudential-Bache's annual health care conference Oct. 12. "The IND was submitted last month for one which blocks absorption and uptake of dietary cholesterol. A follow-on product will enter the clinic in the fourth quarter," Cresswell said. The third product, an HMG co-A reductase inhibitor in the same class as Merck's Mevacor, "lowers serum lipid levels by interfering with the body's ability to produce its own cholesterol," Cresswell said. "We expect to submit an IND on this compound within the next several months." The compounds were developed in-house. To support cardiovascular R&D, the company is spending about $80 mil. this year, roughly one-third of its $300 mil. R&D budget. Next year, the company has earmarked $350 mil. for R&D, of which $240 mil. will be directed at pharmaceutical research, Cresswell noted. Nearer term anticholesterol research includes a one-a-day version of Lopid in Phase III study. A timely approval would allow the company to further extend its exclusivity for Lopid beyond the 1993 patent expiration date already extended by Congress. The product uses an internally developed delivery mechanism. "Our strategy is to get the new product into the market well before the expiration to give us additional exclusivity," Cresswell explained. He also noted that the company is "investigating the hypothesis that Lopid actually halts the development of atheromas in the blood vessels. This could be key to the drug's mechanism of action." Baylor University researcher Peter Kuo is conducting preliminary studies on Lopid's effect on plaque formation. Cresswell's Pru-Bache presentation -- his first since being elevated from president to chairman of the Pharmaceutical R&D Division -- gave him a chance to introduce his successor, former Glaxo exec Pedro Cuatrecasas, MD, and to discuss Warner-Lambert's evolving R&D program. Cuatrecasas, 53, will be responsible for the "day-to-day scientific activities of our global effort," Cresswell explained, adding: "Obviously, he will participate in developing our long-term strategies and direction for pharmaceutical research." Cuatrecasas will be headquartered at the company's primary research facility in Ann Arbor, Michigan and oversee the firm's worldwide network of five other lab facilities in Freiburg, West Germany; Sagimahara, Japan; Toronto, Canada; and Morris Plains, N.J. Cresswell and Cuatrecasas have known each other for a number of years, having been colleagues at Burroughs Wellcome from 1975-1986. Cuatrecasas, who joined Burroughs Wellcome in 1975, left his VP-R&D, development and medicine post there in January 1986 to join Glaxo as VP-R&D for the U.S. He resigned from Glaxo in mid-July and was later hired by Warner-Lambert. In addition to the R&D presidency, Cuatrecasas will soon be named as a Warner-Lambert corporate VP and member of the company's management committee. Cresswell, since replacing Gerald Weisbach 16 months ago as the head of Warner-Lambert's R&D effort, has pared back Warner-Lambert's pharmaceutical program. He has reduced the list of drug discovery categories from 15 to 10, with further reductions planned by 1991. Cresswell has also decreased the total number of compounds under active study from 50 to 40. He noted that the company will have 12 compounds at the IND filing stage in 1990. Simultaneous with the increased R&D budget and narrowed focus, Warner-Lambert has added 200 new positions this year, "largely in clinical and development areas," Cresswell said. Warner-Lambert's Ann Arbor R&D facility is being expanded and the company is "doubling the size" of its Cambridge, England drug discovery facility, he added. Cresswell reported that approximately 95% of the firm's R&D resources at facilities in Cambridge and Freiburg have been allocated to cholycys-takinines (CCK) agonists and antagonists -- neuropeptides that have potential in treating anxiety, eating disorders and other central nervous system afflictions. The compounds, all in the early development stage, were discovered in-house. Warner-Lambert's activities in the CNS field are focused on cognition, stroke, behavioral compounds and neuropeptides. The lead compound, Cognex (tacrine or THA), is currently being evaluated by the National Institutes of Health in 300 Alzheimer's patients at 17 centers. The company continues to forecast a mid-1990 NDA submission for Cognex. At the same time, Warner-Lambert is in discussions with other firms that might be able to provide "complementary capability" to the company's 1988 agreement with Chiron that moved Warner-Lambert into the area of CNS biotechnology ("The Pink Sheet" Oct. 10, 1988, T&G-2). Warner-Lambert is continuing to look outside for new compounds. On Oct. 12, the company announced its second quinolone-licensing agreement with Dainippon Pharmaceutical of Osaka, Japan for an advanced antibacterial designated AT-4140. The company is also "finalizing arrangements in another advanced antibacterial," Cresswell told Pru-Bache. Dainippon has Phase III trials underway in Japan on the new quinolone, and Warner-Lambert expects to file an IND for the drug before the end of the year in order to develop its own database. Warner-Lambert licensed the quinolone antibacterial Comprecin (enoxacin) from Dainippon in 1982. "There is an excellent chance that Comprecin will clear the FDA in time for U.S. introduction in early 1990" in oral and injectable forms, Cresswell remarked. Enoxacin now is marketed in 10 countries. Warner-Lambert is also working on an I.V. formulation of the drug. In an Oct. 17 sales and earnings report for the third quarter, Warner-Lambert said that 80% of the company's $350 mil. corporate R&D investment in 1990 will be focused on pharmaceutical R&D, "keeping Warner-Lambert among the industry leaders with spending at 18% of pharmaceutical sales," the company noted. Warner-Lambert added that its strategic plan "calls for a $1.8 bil. investment in R&D over the next five years." Warner-Lambert announced that sales for the three-month period ended Sept. 30 rose 7% to $1.1 bil. while net income increased 22% to $107 mil. Adjusting for the strong dollar and its effect on foreign sales, third quarter sales would have been up 11%, the company said. Ethical pharmaceutical sales rose 9% to $320 mil. in the quarter. In the U.S., Warner-Lambert prescription drug sales were up 15% in the quarter. The company credited Lopid and the calcium channel blocker Dilzem for the worldwide ethical drug sales increase.

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