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WARNER-LAMBERT COGNEX SEPTEMBER SELL-IN IS $15 MIL.

Executive Summary

WARNER-LAMBERT COGNEX SEPTEMBER SELL-IN IS $15 MIL., Warner- Lambert President Lodewijk de Vink told the Mabon Securities Research Conference Nov. 3 in New York City. Cognex (tacrine) was approved Sept. 9 and Warner-Lambert began shipping the drug in late September. Warner-Lambert "continues to believe" that the drug will post sales of approximately $35 mil. for 1993 and "well over $100 mil." in 1994, de Vink said. "We believe that it has the ultimate capability of producing sales in the hundreds of millions of dollars." The uptake of Cognex "was not slower than what we expected," de Vink said, acknowledging that some securities analysts have said "it was slower than what they expected." He pointed out that the drug is "very different than what we have been marketing in the past." The "patient profile is so different," de Vink said. Warner-Lambert will be funding a campaign by the Alzheimer's Association that will focus on the 10 warning signs of the disease, the company reported. The company wants "patients who have the disease [to become] a little bit more proactive in seeking treatment," de Vink said. "We at Warner-Lambert recognize the importance of Cognex for Parke-Davis' future and we will do everything to speed up the adoption process." However, de Vink stressed, Warner-Lambert will "make 100% sure that we are not going to [say] 'this cures Alzheimer's.'" The company's "job will be to manage expectations," he said. "Cognex is not a cure. We see it as the drug of choice -- indeed the only drug -- for the treatment of Alzheimer's, because it improves cognition, behavioral function and quality of life." The company's "biggest objective is to fill the reasonable continued demand rather than having...a lot of disappointment and a lot of people saying it doesn't work." Moreover, de Vink continued, Warner-Lambert has "no intention of trying to clash with FDA" by making "claims outside the labeling." FDA's approval letter for Cognex cautioned the company against overstating the benefit of Cognex. The letter noted that Warner-Lambert's initial submitted campaign materials would have been violative ("The Pink Sheet" Sept. 13, p. 6). In addition to highlighting patient awareness of Alzheimer's, Warner-Lambert is hoping to strengthen its message to physicians. De Vink said the company has not been emphasizing the pivotal Cognex study (protocol 970-61) pending publication in a medical journal. "Once it is published, I think we can make that study much better available." The company indicated that the study could be published before the end of the year. For the longer term, Warner-Lambert hopes to use the ongoing Treatment IND for Cognex to strengthen the labeling claims. The Treatment IND protocol is now using biweekly blood monitoring as opposed to the labeled weekly monitoring, the company said. In addition, de Vink said, the Treatment IND could provide more evidence of the efficacy of the higher doses of Cognex used in 970-61. Cognex is especially important to Warner-Lambert in light of the expiration of the Lopid patent and the manufacturing consent decree signed by the company in August that called for the suspension of production of many of the firm's older products ("The Pink Sheet" Aug. 23, p. 10). "We want to keep our plants busy," de Vink said. "We don't want to be stuck with overhead." "Through nine months, the combined sales of Lopid and Warner Chilcott generic gemfibrozil are down 6% versus prior year," de Vink said. "With Lederle's generic version now on the market, [Teva/Lemmon's] recent approval and others expected to follow, this erosion will accelerate." In competing against the new generics, "I don't think we're going to match them dollar for dollar, account for account," de Vink said. Warner-Lambert is looking to outlicense some of the products covered by the consent decree, de Vink said. "We're dealing with marginal products and our field forces are tied up" with Cognex, Accupril and Lopid and expecting Neurontin, he said. "We don't have the internal horsepower to go back to the doctors...to get these old products...back on the prescription pad." He suggested some niche marketing companies may be interested in promoting the products.
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