To: Sonki who wrote (112 ) 12/1/1997 7:19:00 PM From: Ted Downs Respond to of 942
sonki, From Dow Jones... "We expected the revised labeling for Rezulin to result in an increase in reporting of liver enzymes elevation," said Goldman Sachs & Co. analyst Prem Lachman. "This naturally occurs following a re-labeling and highlight of a specific issue." Lachman, who recommends aggressive buying of Warner-Lambert on the stock weakness, continues to believe doctors still consider Rezulin to be one of the better oral diabetic drugs for non-insulin-dependent diabetes patients. Glaxo licenses the drug, which is the first to directly attack the underlying causes of Type II diabetes, from Japanese pharmaceutical concern Sankyo Company Ltd. The drug has been available in the U.K. since Oct. 1, with an estimated 5,000 patients receiving treatment. Sankyo said it has received reports of 13 cases of serious liver damage from patients using the drug, and three of those patients died. A spokesman for Sankyo couldn't deny the deaths were related to the drug, a spokesman for the Japanese company said. "In the light of these reports and in the interests of patient safety, Glaxo Wellcome has decided that it needs time to evaluate further the safety profile of troglitazone," the company said. Glaxo (GLX) is licensed to sell the drug in Europe and other countries, including South Africa and Israel, although the U.K. is the only country in which it has sold the product. Jeffrey Kraws, who follows Warner-Lambert for Everen Securities Inc., said it is unclear whether some of the more serious problems reported may have resulted from other complications, drug interactions, or other events. The uncertainty surrounding the product may hurt what Warner-Lambert had hoped would be a blockbuster drug. Warner-Lambert had forecast that Rezulin would ultimately generate annual sales of $1 billion. So far this year, Rezulin has generated sales of $242 million through the third quarter. Warner-Lambert's other highly touted drug, Lipitor, dramatically lowers cholesterol. The company hoped the two drugs would play a major role in turning around its slumping drug unit. Last year's revenue came in at $7.2 billion. A late October research report from Merrill Lynch & Co. estimated combined sales of Rezulin and Lipitor of about $1.1 billion this year. The new information adds additional risk and cost considerations for diabetes patients. Rezulin already is expensive, costing about $4.70 a day for the most common dose. The liver-function blood tests will cost about $15 to $20 each, a company spokesman has estimated. Jay Silverman, an analyst at BancAmerica Robertson Stephens, said the brutal selloff in Warner-Lambert shares could result from concerns that Glaxo Wellcome's actions may lead Warner-Lambert and even the FDA to re-examine Rezulin's use in the U.S. A spokesman at Warner-Lambert flatly denied that scenario. "We continue to believe Rezulin is a breakthrough therapy whose profound benefits far outweigh any risks," he said. "What we've seen is that the drug is generally very well-tolerated in patients." Indeed, an FDA statement released Monday said the agency "continues to find the benefits outweigh the risks for treating appropriately selected and monitored type-II diabetes patients with Rezulin." The FDA went on to say that the increased monitoring of patients taking the drug is designed to detect "those few patients" in whom use of the drug can lead to serious liver damage. James Keeney, an analyst with Rodman & Renshaw Inc., said he expects Romozin to be reinstated in the U.K. market some time next year, once monitoring guidelines are better understood. Goldman Sachs' Lachman, though, said Glaxo Wellcome is developing its own glitazone drug, which is entering interim-stage trials and may have played a role in the company's decision. "We wonder what their motivation is with respect to the (suspension)," Lachman said. Keeney reduced his 1998 and 1999 Rezulin sales estimates by $200 million to $550 million and by $275 million to $700 million, respectively. He lowered his 1998 earnings estimate 40 cents to $4.15 a share and and by 60 cents to $5.30 a share for 1999. He also cut his rating to neutral from buy. Lachman left his 1998 earnings estimate of $4.50 a share unchanged. Copyright (c) 1997 Dow Jones & Company, Inc. All Rights Reserved. Transmitted: 12/01/97 18:19 (L100ZX9r)