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WARNER-LAMBERT PIPELINE NARROWED TO 40 ACTIVE RESEARCH COMPOUNDS: ACCUPRIL (QUINAPRIL) NDA SUBMITTED JAN. 25; $80 MIL. BUDGETTED FOR C-V WORK IN 1989

Executive Summary

Warner-Lambert has cut work on one-fifth of its research projects, reducing the number of projects under active study from 50 to 40 in an effort to focus its R&D resources, R&D President Ronald Cresswell, PhD, reported at a Jan. 24 meeting with security analysts in New York City Jan. 24. "In prioritizing our pipeline from 50 to 40 compounds," Cresswell explained, "we've simply recognized that our resources are finite while development costs are escalating, as demands from drug regulatory agencies increase and the discovery process itself becomes more complex." The majority of the 10 compounds dropped from the program were anticancer drugs, Chairman Joseph Williams told the analysts. Anticancer compounds recently discontinued from Warner-Lambert's R&D pipeline include dezaguanine mesylate (licensed from Viratek), diaziquone, fostriecin Na (CI-920) and piroxanthrone HC1. Among other projects dropped for 1989 are an ACE inhibitor, CI-225, the non-sedating antihistamine tazifylline, which had been licensed from Syntex, a second generation quinolone antibiotic and an HMG CoA reductase inhibitor. Warner-Lambert has also quietly discontinued AIDS development work on a compound that had the interest of the National Institute of Allergy & Infectious Disease. The company reported halting pneumocystis carinii studies with trimetrexate. Warner-Lambert says, however, that it is continuing work with the product in the area of non-small cell lung cancer. "As a function of education and the effectiveness of pentamidine, the disease (pneumocystis carinii) rate has fallen by 50% [in the past year] and its death rate has dropped by 10%," Cresswell said. The Warner-Lambert exec noted that "in essence, the disease simply isn't the menace it appeared to be 12 months ago." However, the company will continue to supply the drug to patients upon request under a compassionate IND. The company's R&D budget for 1989 will be "approximately $300 mil. with roughly 80% [about $240 mil.] going for pharmaceutical research and allocated among four categories: cardiovasculars, chemotherapy agents, CNS and inflammatory disease treatments. Heart disease R&D is slated to receive about $80 mil. in 1989, Cresswell indicated, or "about a third of our funding." The program will concentrate on atherosclerosis, hypertension and heart failure. The chemotherapy program will focus on infectious disease and cancer. Cognition remains a "primary target" of Warner-Lambert's CNS work with other efforts looking into "stroke, behavioral compounds and neuropeptides as analgesics," according to Cresswell. Tacrine (THA) is drawing the most outside interest among Warner-Lambert's current cognition work. The company told the analysts that FDA's Peripheral and CNS Drugs Advisory Panel held a closed meeting Dec. 20 on the drug's use in Alzheimer's disease. The advisory committee reportedly reviewed all existing worldwide data on THA with regard to safety issues. The company was not asked to appear at the meeting. There are currently more than 300 patients in two double-blind studies. Cresswell said the company hopes to have specific information on those studies "later this year." Other Warner-Lambert cognition activators include CI-844, which has shown biological activity. However, the company is treating the compound as a secondary project in relation to THA. CI-933 and pramiracetam sulfate remain in Phase II. The non-teratogenic anticonvulsant gabapentin continues to move through the pipeline and "is expected to be ready for global registration in 1991, including an NDA filing," Cresswell said. Warner-Lambert submitted the NDA for Accupril (quinapril) for hypertension on Jan. 25. The company will initially seek approval for the once-a-day ACE inhibitor in mild-to-moderate hypertension. "Based on clinical studies among 3,000 patients, the compound matches up very well therapeutically against the marketed drugs, [Squibb's] Capoten and [Merck's] Vasotec," Cresswell commented. "Our research has suggested that Accupril is their equal in treating hypertension. Our investigators also believe that their clinical studies demonstrate Accupril's efficacy in treating congestive heart failure," he noted. In response to a question, Cresswell indicated that quinapril may have a "significant" safety advantage over the currently marketed ACE inhibitors, but did not specify. The anti-arrhythmic pirmenol is currently the subject of multi-center studies on patients with tachycardia. In some 60 clinical trials already completed on the compound in both oral and IV forms, pirmenol demonstrated "a superior side-effect profile," Cresswell commented. The drug will compete with such products as Enkaid (Bristol-Myers) in a market Cresswell estimated at $500 mil. In anticancer research, W-L has two compounds, designated orphans, in advanced stages of development to fight leukemia: Pentostatin, in Phase III trials for hairy cell leukemia with a response rate "roughly twice that of presently recognized therapy," and Amsidyl (amsacrine), for which an NDA will be submitted in 1989 as first line therapy. Cresswell said he expected FDA approval and U.K. approval of the quinolone derivative Comprecin (enoxacin) during 1989. Warner-Lambert has licensed the compound from Dainippon and hopes to have the drug in most major markets by 1990. The NDA is for an oral dosage form of the anti-infective, and "work is progressing on an intravenous form of Comprecin." Warner-Lambert's licensing partner for a transdermal nicotine patch, the Irish firm Elan, indicated last week that it hopes to file the NDA in February. Warner-Lambert Exec VP Don O'Neill said Elan plans to submit the NDA in the "late second quarter." When asked to compared the Elan patch to a Ciba-Geigy version in Phase III testing, O'Neill said: "Ciba's is a 30 cm patch and our's is about 7 cm . . . We have a much higher degree of effectiveness than their product, at least what we've seen in print on their clinical trials." Ciba says that it is studying a range of sizes from 10 to 30 cm. Williams said there is always room for another product. In the beta-blocker market, Warner-Lambert is less sanguine about the possibilities for one more product. The company said that it has decided not to market Vantol (bevantolol). "Who needs the 30th beta blocker?" Williams said in response to a question on Vantol's pending NDA. Other drugs in the late phases of the pipeline have a brighter future than bevantolol, according to Williams. "We're in the process where hopefully we'll have it approved this year," he said of the beta agonist Pro-Air (procaterol). NAPA, the procainamide treatment for ventricular arrhythmia, also "hopefully will be approved this year," Williams noted. Parke-Davis currently has a "major" Phase III trial ongoing for the triphasic oral contraceptive Estrostep. A "couple" of the studies had to be repeated because of concerns over inadequate double-blinding for the packages, but Warner-Lambert anticipates completing the studies "about 1990 and submitting the NDA that year," Parke-Davis President Sam Maugeri said.
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