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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: bob zagorin who wrote (21921)	6/6/1998 4:41:00 AM
From: Alper H.YUKSEL	Respond to of 32384

WARNER-LAMBERT DIABETES DRUG STUDY STOPPED AFTER PATIENT DIES MORRIS PLAINS, N.J. -(Dow Jones)-Warner-Lambert Co. said Friday a federal study trying to determine if the company's diabetes drug Rezulin can be used to prevent the onset of the disease in non-diabetics was discontinued. The study was ended after a patient in the study suffered liver failure, required a transplant and subsequently died, although Warner-Lambert stressed that the death apparently stemmed from factors that were unrelated to the study or the medication. Despite that, the study's end may put a damper on Warner-Lambert's efforts to widen use of the drug, which was approved last year. However, the company isn't expected to be significantly affected by the end of the trial. Reports of liver damage in some diabetic patients taking the drug surfaced late last year, and the drug company added warning labels to the drug telling doctors to carefully monitor their patients' livers. Glaxo Wellcome PLC, however, pulled the drug from sale in the United Kingdom, where it has a license to sell Rezulin. Warner-Lambert said the decision to end the study doesn't affect patients with type II diabetes who take the drug. Type II diabetes usually develops in adulthood and sometimes requires insulin shots. Rezulin works by attacking the underlying causes of the disease. It lowers blood sugar by increasing a diabetes patient's sensitivity to insulin. The study was being conducted at the National Institutes of Health under its Diabetes Prevention Program, a nation-wide research study conducted by the National Institute of Diabetes and Digestive and Kidney Diseases, a division of the NIH. The study tried to determine whether type II diabetes can be prevented or delayed in people with impaired glucose tolerance, or IGT, a possible precursor to diabetes. Warner-Lambert said there is a "significant difference" between people with type II diabetes and those with IGT. "IGT is not currently a recognized disease and is not treated with medication. People with IGT may or may not develop type II diabetes," Warner-Lambert said. The patient who died in the study was found to have a serious lesion and extensive necrosis, or localized death of living tissue, in the bowel, which appears to have contributed to the cause of death, the drug company said. The necrosis may have been related to a cytomegalovirus (CMV) infection in the patient. The bowel lesion was potentially lethal and its cause, while undetermined, can't be attributed to Rezulin or liver disease, Warner-Lambert said. Rezulin is one of a pair of new drugs launched by Warner-Lambert last year that it hopes will become billion-dollar products and turn around the company's flagging drug business. The other drug is Lipitor, a powerful cholesterol-lowering agent it sells with Pfizer Inc. Warner-Lambert is considering whether to launch its own clinical trial for preventing diabetes in patients with IGT, said company spokesman Stephen Mock. Wall Street observers noted that analysts' revenue projections for the Morris Plains, N.J., pharmaceutical company don't include potential sales from the use of Rezulin for this indication. With Warner-Lambert continuing to enjoy runaway sales of its cholesterol-lowering drug Lipitor, a minor setback for Rezulin won't affect the company in a meaningful way, according to HKS & Co. analyst Hemant Shah. The removal of Rezulin from the NIH study could cause a short-term dip in prescriptions of the drug, said Furman Selz Inc. analyst James Flynn. He noted that the majority of doctors who prescribe Rezulin aren't diabetes specialists and are more likely to be concerned by the news. He added that he doesn't expect the impact to be lasting.