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LOPID SALES COULD REACH $ 300 MIL. IN "NEXT FEW YEARS," WARNER-LAMBERT TELLS ANALYSTS CITING HELSINKI HEART STUDY; PATENT EXTENSION IS CRITICAL FACTOR

Executive Summary

Worldwide Lopid (gemfibrozil) sales could triple "in the next few years" from their current $ 100 mil. level, as Warner-Lambert begins to capitalize on results of the Helsinki heart study, the company told securities analysts at a Jan. 19 presentation in New York. "Two projects are receiving priority attention," President Melvin Goodes noted. "The first is to fulfill our responsibility to the medical community by communicating the results as widely as possible to medical opinion leaders. Our other assignment . . . is to file for a coronary heart disease reduction claim with the FDA." Referring to the supplemental NDA filing for Lopid as a "high priority," Goodes said the company is "proceeding with a high sense of urgency" and anticipates completion of the full submission "within the very near future." At the same time, Warner-Lambert plans to continue through 1988 with the series of seminars and professional presentations begun immediately after the study's November publication in The New England Journal of Medicine. Lopid revenues could also benefit from the recently revised U.S. cholesterol guidelines, Goodes added. "By reducing the level at which cholesterol concentrations are considered dangerous, and by encouraging the screening of young people, the at-risk population is expected to nearly double to about 40 mil.," he explained. Lopid's future beyond the first half of 1989, when the product's patent expires, appears to hinge on the company's ability to obtain extended patent protection from Congress. Warner-Lambert Chairman Joseph Williams expressed confidence in the company's efforts thus far. "Legislators seem to understand our arguments relating to high risk and fairness, an overall investment of $ 177 mil. in Lopid's development, the basic 'landmark' research associated with the Helsinki Study and the change in ground rules affecting patent protection during the mandated Phase IV post-marketing study," he remarked. "We will continue to pursue the issue to a successful conclusion." At an October hearing in Washington, Williams pledged an inflation-adjusted stable price for Lopid in exchange for patent protection through 1994. Physicians have apparently begun responding to the Helsinki Heart Study results. The company reported IMS data prior to publication of the study showing Merck's Mevacor (lovastatin) the market leader in new prescriptions for anti-cholesterol drugs with a 33% share, compared to 23% for Lopid. By the first week of January, Lopid was back on top with a 32% share of new Rxs compared to 29% for Mevacor, according to the company. With the anticipated sales increases from Lopid and other cardiovascular products, the company said it plans to reorganize the Parke-Davis force to increase physician reach and frequency of calls on cardiologists. Goodes reported that despite recent generic inroads, Procan SR (procainamide) remains the anti-arrhythmic market leader, ahead of both Quinidex and Norpace. The company reported that Procan worldwide sales dipped 11% to $ 40 mil. in 1987. W-L is more difficult for the investment community to track because the company does not ride the success of one or two major products. W-L disclosed a very detailed profile of its Rx business at the Jan. 19 meeting. The company had three Rx products with more than $ 100 mil. sales in 1987 and five products and product groups with sales between $ 40-$ 48 mil. In a recent ranking of Rx growth among the top U.S.-based drug companies put together by Squibb, W-L ranked sixth, just behind Merck and ahead of Lilly. Parke-Davis is currently awaiting FDA approval for bevantolol, a cardio-selective beta blocker, and Cholybar, a chewable bar formulation of cholystyramine, for which an ANDA was filed in 1987. "It will be initially available in two flavors with others to follow," Goodes said. "We're confident Cholybar could ultimately be a $ 50 mil. product." Two other NDA filings are awaiting FDA action -- Pro-Air (procaterol), a beta agonist bronchodilator for treatment of asthma, and Comprecin (enoxacin). The latter belongs to the broad-spectrum, quinolone class of antibiotics and is under review for five types of infections. Parke-Davis is developing both oral and injectable formulations of enoxacin. The product was marketed in six countries in 1987, with six more launches, inluding the U.K., planned for this year. Further back in the cardiovascular pipeline are the ACE inhibitor quinipril and the anti-arrhythmic pirmenol. The company plans to file a quinipril NDA for hypertension and congestive heart failure in the fourth quarter of 1988, while a filing for pirmenol is scheduled for 1989. Also on track for an NDA filing this year, Goodes reported, is trimetrexate, an anticancer compound that has shown efficacy against Pneu mocystis carinii. In addition to the 350-patient NIH study getting underway at 20 AIDS treatment centers, Warner-Lambert also plans to conduct a separate study of its own. FDA has given trimetrexate a 1AA designation, the second drug to receive such a classification. Another AIDS drug, Burroughs Wellcome's Retrovir (zidovudine) was the first. The company used the forum of the analysts meeting to announce the planned restart of clinicals studies with THA for Alzheimer's disease. In November, the trials were halted when elevated liver enzyme levels were seen in some patients receiving the second highest of four THA dosage regimens. Because the condition is reversible, a decision has been made, in conjunction with FDA, to restart patients on a lower dosage of THA. The initial protocol, announced in August, called for a two-year study involving approximately 300 patients. To help support Dilantin (phenytoin) in the anticonvulsant market, Parke-Davis is accelerating Phase III development of gabapentin, which has shown an ability to control seizures without impairing cognitive or liver function. An NDA filing is targeted for 1990. Meanwhile, Dilantin continues to perform well. Worldwide sales reached $ 116 mil. in 1987 and new prescriptions in the U.S. were up 11%. Warner-Lambert's generic business, Warner Chilcott, grew 54% in 1987 to $ 54 mil. "The increase in sales was aided by the addition of 76 products introduced in 1987, including cephalexin," Goodes noted. The company expects to expand its product line to 150 by the end of 1988 and achieve sales of $ 70 mil. Warner-Lambert's gelatin capsule manufacturing subsidiary, Capsugel, increased sales 7% in 1987 to $ 125 mil., Goodes reported, with a similar increase projected for 1988. Capsugel produces approximately 50 bil. capsules a year, supplying about half of the worldwide market, according to the company. Total R&D expenditures were up about 15% in 1987 to $ 232. Williams noted that in 1988 the company plans to spend $ 255 mil., of which 80%, or over $ 200 mil., is earmarked for the pharmaceutical area. The figure is about 16% of projected pharmaceutical sales. A move into the biotechnology area is also likely in 1988. Williams reported that the company is negotiating collaborative agreements "with established companies" in the field of receptor technology. "We're currently finalizing these agreements as well as assembling our own biotechnology staff," he added. Chart omitted.
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