WARNER-LAMBERT LOSES $ 34 MIL. IN PHARMACEUTICAL SALES DUE TO GMP PROBLEMS

WARNER-LAMBERT LOSES $ 34 MIL. IN PHARMACEUTICAL SALES DUE TO GMP PROBLEMS in the second quarter, the company reported July 20. The $ 34 mil. brings to just under $ 60 mil. the total dollar amount that Warner-Lambert has lost in sales this year because of continuing compliance problems, primarily at its Puerto Rico facilities. Pharmaceutical sales were down 8% to $ 270 mil. for the quarter compared to last year. By comparison, pharmaceutical sales outside the U.S. decreased by 3% relative to the same period last year. Worldwide pharmaceutical sales for the quarter were down 6% to $ 532 mil. Second quarter sales of consumer products in the U.S. dropped 2% (see related story, p. 7). Costs associated with correcting manufacturing problems, primarily in Puerto Rico, "hurt U.S. pharmaceutical sector results," the company said. "Our discussions with FDA have been productive, and we are devoting all the appropriate resources of the corporation to our compliance with good manufacturing practices," Warner-Lambert maintained. The financial impact of the manufacturing problems, the company said, "appears to be manageable. However, coupled with the delay in Cognex approval, it will undercut our ability to generate double-digit earnings growth for the year." Warner-Lambert expects to sign a consent decree shortly with FDA to resolve its manufacturing difficulties. ("The Tan Sheet" July 12, p. 16). The consent decree, which is subject to court approval, will require the company to bring its facilities into compliance and possibly revalidate the manufacturing processes for certain products prior to shipping. Approval of Cognex (tacrine) could come quickly following signing of the consent decree. No issues appear to remain outstanding in approval of the Alzheimer's disease therapy other than possibly manufacturing issues, since the drug is to be made at the company's Vega Baja, Puerto Rico facility. Of products made at the Puerto Rico plant, Warner-Lambert resumed shipments on a limited basis of its delayed-release erythromycin product Eryc the week of July 12. Eryc has been unavailable to wholesalers since December 1992. The company has shifted manufacture of the product from Puerto Rico to its Morris Plains, N.J. facility and is purchasing the bulk enteric-coated product from Australian firm Faulding, which supplied Warner- Lambert with delayed-release erythromycin until 1991, prior to its manufacture in Puerto Rico. Faulding is also the source for one of the few generic versions of Eryc, marketed by Purepac.