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WARNER-LAMBERT ACCUPRIL AND ONCOPENT APPROVALS ARE "IMMINENT"

Executive Summary

WARNER-LAMBERT ACCUPRIL AND ONCOPENT APPROVALS ARE "IMMINENT," Warner-Lambert Senior VP Pharmaceutical Research Donald Maxwell, MD, predicted at a July 31 analysts' meeting in Milwaukee sponsored by Robert W. Baird. With the broad-spectrum quinolone Penetrex (enoxacin), which has been approvable at FDA since December, Warner-Lambert is in the position of holding three likely candidates for approval in the second half of 1991, despite the company's problems with the Alzheimer's drug Cognex. The ACE inhibitor Accupril (quinapril) has been pending at FDA since January 1989 for hypertension. FDA appears to be making fast headway through ACE inhibitor approvals in recent months. In June, Ciba-Geigy's Lotensin (benazepril) became the third new ACE inhibitor approved this year. Bristol-Myers Squibb's Monopril (fosinopril) was approved in May, 30 months after its NDA was filed, and Hoechst's Altace (ramipril) was approved in January after a 27-month review. Warner-Lambert will stress Accupril's once-daily dosage form and "excellent tolerance" to make headway in the crowded ACE inhibitor market, Maxwell said at the July 31 meeting. "In efficacy, it matches up very well against the market leaders, enalapril [Merck's Vasotec] and captopril [Squibb's Capoten]," he added. Pentostatin was unanimously recommended for approval for the treatment of refractory hairy cell leukemia by FDA's Oncologic Drugs Advisory Committee at its most recent meeting ("The Pink Sheet" July 8, p. 4). The NDA for pentostatin was filed in February. The drug has been available under a Group C/Treatment IND since July 1988. The broad spectrum oral quinolone Penetrex (former tradename Comprecin) has been approvable for six months but reportedly has been held up by disagreements between the company and FDA over how broad labeling claims should be. Warner-Lambert has studied the antibiotic for respiratory tract infections, skin infections, urinary tract infections and genital infections, including gonorrhea. Warner-Lambert has a total of six products awaiting approval at FDA. An NDA was filed in February for Lopid SR, the gradual release once-a-day formulation with which Warner-Lambert hopes to evergreen the market for it best-selling cholesterol reducer Lopid. The company also has NDAs pending for the beta-agonist bronchodilator Pro-Air (procaterol) and Cognex. Maxwell said that Warner-Lambert is "evaluating" the Cognex recommendations made by FDA's Peripheral & CNS Drugs Advisory Committee at its July 15 meeting and "is working closely with the FDA to determine what steps will be taken next regarding this drug." The committee recommended that the company be required to start another clinical trial with Cognex before it should be allowed to distribute the drug under a Treatment IND ("The Pink Sheet" July 22, p. 6). Warner-Lambert said that FDA has not decided whether the company will have to conduct such a trial. Joe Williams, in one of his last activities as Warner-Lambert CEO, met with FDA Commissioner Kessler and FDA Ombudsman Amanda Pedersen on July 25 to discuss Cognex and other topics. Maxwell also updated the analysts on the company's early-stage clinical activities. Five agents in the company's pipeline have made progress in early clinicals since a rundown on products in development given at Warner-Lambert's meeting for analysts in April ("The Pink Sheet" April 29, p. 8). CI-976, one of a new class of cholesterol-lowering agents called ACAT inhibitors, is now in Phase II clinicals, Maxwell reported. An IND is planned in early 1992 for CI-992, one of a group of oral anti-hypertensive "renin inhibitors" the firm is studying for reduction in arterial pressure. Sparfloxacin (formerly CI-978), a fluoroquinolone for which Warner-Lambert filed an IND earlier this year, has entered Phase I for "community acquired infections" as well as for mycobacterium avium in AIDS patients. In the CNS research area, the company has completed Phase I study of its cholecystokinin (CCK) receptor antagonist, CI-988, as an anxiolytic; the company is looking at the product both for treatment of panic attacks and as a possible treatment for drug dependency. Phase I trials are also underway, Maxwell noted, for a potential Alzheimer's therapy, CI-979, a direct acting muscarinic agonist that "mimics the actions of the neurotransmitter acetylcholine," thought to be deficient in Alzheimer's disease victims.

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