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Executive Summary

Warner-Lambert's Warner Chilcott generics business will cross the $100 mil. sales mark this year, Warner-Lambert President Lodewijk de Vink told the New York Society of Security Analysts at an April 21 meeting in New York City. A division of W-L's Parke-Davis prescription drug business, Warner Chilcott increased its revenues by 70% in 1991, de Vink said. At $100 mil., Warner Chilcott would account for approximately 5% of Parke-Davis' overall 1991 revenues of about $2 bil. While representing a relatively small component of W-L's total drug business, Warner Chilcott's 1991 performance is credited as one of the factors driving growth in U.S. pharmaceutical sales last year in the company's just-released annual report. The generics business sells a broad range of drugs, led by the antibiotic minocycline. Products coming on line this year will probably include gemfibrozil (Lopid) (see related story, p. 9). As other in-house products go multisource, W-L also may look at Dilantin (phenytoin) as a generic candidate. While Dilantin is already off-patent, brandname sales have been reinvigorated by the bioequivalency problems of generic competitors. Currently, there is no "AB"-rated therapeutic equivalent to Parke-Davis' oral phenytoin formulation. Dilantin sales reached $184 mil. in 1991, up 21% from $152 mil. in 1990. Asked at the meeting about the longterm prospects for Dilantin, W-L Chairman Melvin Goodes noted that "the recovery that you are seeing in Dilantin is due really to the fact that there were some companies that were fraudulently producing our product and did not meet the standards....So what we are doing is recouping some of the historical losses we took on some of the products." Goodes added that the company is working on a 300 mg formulation that it hopes to introduce "in the near future." Beyond its own in-house stable of off-patent drugs, W-L is looking at a number of "major" multisource candidates, including piroxicam (Pfizer's Feldene). Asked during a question-and-answer session whether W-L is actually taking orders for "generic Feldene," Goodes dodged artfully: "That's one we'd be interested in marketing." The market for generic piroxicam may be up for grabs given FDA's veto of Royce Labs' ANDA for a first generic due to ANDA discrepancies (see related item, T&G-1). Goodes said that W-L is "interested in a lot of the major products that are coming off patent," including piroxicam. However, W-L does not as yet have approval to manufacture the drug, Goodes added. Feldene's patent expired April 6. On the brandname side, the angiotensin-converting enzyme inhibitor Accupril (quinapril) "has a 2.6% share of the weekly new prescriptions" in the U.S. ACE inhibitor category after three months of detailing, de Vink noted. First quarter Accupril sales gained 90% worldwide over the first quarter 1991. "Even though Accupril entered the market long after three competitors, it has received a new Rx market share equal to or better than any of them," said de Vink. "We believe Accupril will be a $250 mil. product in a few years." Accupril currently has a 10% market share in Italy, 7% in France, and "it's off to a strong start in Spain, Switzerland and the Phillipines," de Vink said. The company has filed for FDA approval of an Accupril/diuretic product, which "could be launched in the next 18 months," de Vink added. In the meantime, Parke-Davis is promoting Accupril to physicians as the "Single Agent Commitment." In its product literature, the company promises that if a physician feels the need to prescribe a diuretic "even after an adequate trial of Accupril alone," Parke-Davis will refund any unreimbursed cost of the diuretic to the patient. At the recent American College of Cardiology meeting in Dallas, Parke-Davis announced it will conduct a double-blind, placebo-controlled multicenter trial involving 1,700 patients treated with quinapril or placebo following atherectomy or percutaneous transluminal coronary angioplasty (PTCA) to determine the drug's effectiveness in reducing the incidence of ischemic events. "The Quinapril Ischemic Event Trial (QUIET)...will assess quinapril's ability to reduce the complications of heart disease independent of its effects on blood pressure," Parke-Davis said in an April 12 release. In the central nervous system drug development area, approximately 700 patients have been enrolled in W-L's Treatment IND for the Alzheimer's drug Cognex (tacrine), Goodes reported. Over 900 physicians have volunteered to participate in the program, according to de Vink. However, patient enrollment has been slow to gain momentum. "We are looking at doing some things to speed up the enrollment rate," Goodes said. W-L has said it is aiming for total enrollment of about 15,000 patients ("The Pink Sheet" Feb. 24, T&G-8). "I know there's substantial interest in Cognex," de Vink noted. "Our position is that the day we're convinced that Cognex is not an approvable drug, that's the day we'll stop our investment." He added that "the findings of a recently completed U.S. study have now been filed with FDA and will be submitted for publication in a refereed journal." W-L also is working with Hoechst-AG's affiliate Rouseel-Uclaf in the Alzheimer's area, under a joint agreement for the development of cholinergic compounds. Phase I studies are under way on a muscarinic agonist. "Our plan is to have the best compound codeveloped by both companies," de Vink added. Hoechst-Roussel is working on its own rival cholinergic compound to Cognex, Mentane (velnacine). That product has not yet reached the Treatment IND stage. W-L has been working with Roussel-Uclaf since September. W-L's next generation anti-convulsant Neurontin (gabapentin) "has received a priority [review] rating [from FDA] and will probably receive an accelerated review," de Vink told the group. The company filed an NDA for Neurontin in January. "Based on two large multi-center studies, we expect Neurontin to be a valuable therapy in the treatment of partial complex and simple seizures in refractory patients," de Vink said. In W-L's consumer health business, "improvement" to the ept home pregnancy test line "led to a 42% gain" in 1992, de Vink noted, "enabling us to recapture market leadership." De Vink also commented briefly on W-L's newly-licensed Replens OTC vaginal moisturizer product, which he said would be supported with "the largest advertising and promotion program ever conducted in the category." W-L acquired marketing rights to the product from Columbia Labs last year. The agreement is part of an intensified focus by W-L on women's health care. The company is investigating "aggressively" Rx-to-OTC opportunities, de Vink said. Asked what impact the switch of Marion Merrell Dow's nonsedating antihistamine Seldane (terfenadine) will have on W-L's own Benadryl family of products, Goodes acknowledged that "Seldane is a very big, large selling Rx product....It will have some impact on us." However, he added, "what typically happens in a lot of these categories is that market expansion takes place." Benadryl also may come under pressure from FDA's ongoing review of the status of OTC antihistamines, but the company has indicated that it is not anticipating a large impact since Benadryl sales are mostly derived from allergy sufferers. The W-L execs were asked repeatedly by analysts why the company has not launched a stock buyback program. Goodes said the company is "looking elsewhere" for investment opportunities offering a higher rate of return. In particular, W-L is actively looking for acquisitions to fit in its current three core businesses (pharmaceutical, confections, consumer products), he added.

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