To: Anthony Wong who wrote (214 ) 6/5/1998 11:43:00 AM From: Sonki Read Replies (2) | Respond to of 1722
WLA:is this a buy opp? Changes in NIH Diabetes Prevention Program Announced Today PR Newswire, Friday, June 05, 1998 at 10:09 MORRIS PLAINS, N.J., June 5 /PRNewswire/ -- The Parke-Davis division of Warner-Lambert Company (NYSE:WLA) announced today that it has been notified by the National Institutes of Health (NIH) of its decision to discontinue the troglitazone treatment arm of the Diabetes Prevention Program (DPP). The DPP is a nationwide research study conducted by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a division of the NIH. The objective of the DPP is to determine whether type 2 diabetes can be prevented or delayed in people with impaired glucose tolerance (IGT), a possible precursor to diabetes. This action by NIH pertains to the experimental use of troglitazone in a non-diabetic population. The NIH has informed Warner-Lambert that all patients in the study taking troglitazone have been informed of this change. However, it does not affect patients who take Rezulin (troglitazone) for the treatment of type 2 diabetes. Rezulin is an effective and safe drug when used as indicated for the treatment of type 2 diabetes. Patients currently taking Rezulin for type 2 diabetes can continue to take this therapy with confidence. The decision of the DPP's Data Safety Monitoring Board (DSMB) was the result of one case of liver failure leading to transplantation in a troglitazone-treated individual. The patient subsequently died, apparently due to complications unrelated to the study or the medication. At the time of transplant, this patient also was found to have a serious lesion and extensive necrosis (localized death of living tissue) in the bowel, which appears to have contributed to the cause of death. This necrosis may have been related to a concurrent cytomegalovirus (CMV) infection. This bowel lesion was potentially lethal and its cause, while undetermined, can not be attributed to troglitazone or acute liver disease. This complicated case, and the DSMB's decision with respect to the study, does not change the benefit to risk relationship for Rezulin in patients with type 2 diabetes. Recent changes in Rezulin labeling, which introduced new liver monitoring guidelines, have proven effective. Since then, reported liver events have steadily decreased. Parke-Davis began marketing Rezulin in March 1997 and has extensive post-marketing experience with the drug in nearly one million patients. There is a significant difference between the type 2 diabetes population 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 2 diabetes. Conversely, Rezulin is indicated for the treatment of patients with type 2 diabetes. When type 2 diabetes is left untreated, or when treatments fail to control the disease, serious complications can arise, including cardiovascular disease, blindness, kidney disease and central nervous system disorders. Parke-Davis, a division of Warner-Lambert Company, is devoted to discovering, developing, manufacturing and marketing quality pharmaceutical products. Its central research focus is on heart disease, diabetes, infectious diseases, disorders of the central nervous system and women's health care. Warner-Lambert is a worldwide company employing more than 40,000 people and, along with Parke-Davis, is headquartered in Morris Plains, New Jersey. SOURCE Warner-Lambert Company -0- 06/05/98 /NOTE TO EDITORS: Warner-Lambert's news releases are available at no charge through PR Newswire's Company News On-Call fax service. For a menu of Warner-Lambert news releases or to retrieve a specific release, call 800-758-5804, extension 958887 or prnewswire.com /exec/menu?958887 on the Internet. A free corporate logo to accompany this story is available immediately via Wieck Photo Database to any media with telephoto receiver or electronic darkroom (PC or MacIntosh) capable of accepting overhead transmissions. Call 214-392-0888 to retrieve logo./ /CONTACT: Stephen Mock, 973-540-6696 - Media Relations; and George Shields, 973-540-6916 or Jack Howarth, 973-540-4874 - Investor Relations, all of Warner-Lambert/ Companies or Securities discussed in this article: Symbol Name NYSE:WLA Warner Lambert Co NYSE and AMEX quotes are delayed by at least 20 minutes. All other quotes are delayed by at least