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Executive Summary

Warner-Lambert is planning to launch a generic version of Lopid (gemfibrozil) as one of several defensive maneuvers against the expiration of patent protection for the drug next January. The company had hoped to gain FDA approval this year of a sustained-release formula, Lopid SR, for treatment of coronary heart disease, which would have allowed the firm to maintain many of its Lopid patients on an exclusive formulation. That plan ran into a roadblock at FDA -- the agency has asked W-L to "respond to a number of points," making a year-end approval for the CHD indication unlikely ("The Pink Sheet" March 2, p. 10). Addressing an April 21 meeting of the New York Society of Securities Analysts in New York City, W-L Chairman Melvin Goodes said that while prospects for lengthening the Lopid franchise via the SR formula are falling short of expectations, the company will be helped by its in-house generics operation. "Sure, the Lopid situation is a disappointment," Goodes acknowledged. "But we'll manage our way around it." A big part of the revised strategy apparently will turn on Warner Chilcott, W- L's generics subsidiary. "We do plan to launch a generic form of Lopid," Goodes declared. "We have no intention of abandoning our Lopid franchise." W-L does not need ANDA approval to market generic gemfibrozil because it is the drug innovator. The timeframe for the product launch is being held close to the vest, although presumably Warner Chilcott will be in the market with the product before Jan. 4, the date that exclusivity expires. In charting a strategy for off-patent Lopid, W-L appears to be following the paradigm pioneered by ICI with atenolol. Last July, ICI launched a generic version of Tenormin (atenolol) manufactured by a Puerto Rico affiliate of ICI Chemicals called IPR two months before patent expiration. The company later added Goldline as an additional distributor for the generic version ("The Pink Sheet" Feb. 17, p. 8). In a similar action by another brandname manufacturer, Marion Merrell Dow moved to protect its Cardizem business post-patent by licensing diltiazem to Rugby through a new MMD affiliate ("The Pink Sheet" April 6, p. 3). In addition to manufacturing a generic version of Lopid, Goodes noted that W-L expects to salvage at least a partial claim for Lopid SR. While FDA approval for treatment of CHD appears to be at least temporarily derailed, W-L remains hopeful that "some version" of Lopid SR will be approved this year, probably for a much narrower indication. "What we're doing at the present moment is discussing a claim with respect to triglycerides," Parke-Davis R&D Chairman Ronald Cresswell, PhD, told the analysts. "The nature of the discussion is not one where we have to do additional studies before the drug will be approved." Asked whether such a limited claim will be sufficient to transfer "a lot" of patients over to Lopid SR, Goodes responded: "We didn't say we were going to transfer a lot of patients. We said that's going to be a partial help." Lopid "may be going off patent, but not off our promotion schedule," added W-L President Lodewijk de Vink. "We intend to keep supporting it, clearly differentiating its scientifically proven cardiovascular benefits." Goodes emphasized that W-L has 15 products with sales of $100 mil. or better and a global marketing franchise. While Lopid drove a 19% increase in pharmaceutical revenues during the first quarter, even without the drug, sales in that sector would have been up a healthy 16%. First quarter Lopid sales were $142 mil. worldwide (up more than 28%). Last year, Parke-Davis sales added 17% worldwide, 13% excluding Lopid. W-L points out that 20% of Lopid sales come from non-U.S. markets, where sales will be insulated from the U.S. patent situation.

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