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Xenical for Obesity Filed for Regulatory ApplicationsNUTLEY, N.J., Dec. 2, 1996Roche Laboratories today announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a New Drug Submission (NDS) to the Health Protection Branch (HPB) of Canada to seek approval to market Xenical(R) for patients who suffer from obesity. Xenical, a lipase inhibitor, is the first of an entirely new pharmaceutical class of non-CNS, non-systemic drug therapies for the treatment of obesity. "This regulatory filing is the culmination of an intensive effort on the part of hundreds of Roche employees and physicians throughout the world, all of whom are working to improve the prognosis of patients who suffer from this chronic, relapsing medical disease affecting millions of Americans," said Patrick J. Zenner, President and Chief Executive Officer. "We believe that Xenical will bring enormous value to the obesity community and we will continue to seek regulatory licensing throughout the world." The multicenter, placebo-controlled Phase III clinical trials involving nearly 5,000 obese patients studied the efficacy of Xenical when taken in conjunction with a mildly hypocaloric diet containing approximately one-third of all calories from fat. Xenical is the only treatment to date to have been evaluated in two-year clinical trials for weight loss, maintenance of lost weight, prevention of weight regain and improvement in co-morbidities including hypertension, dyslipidemia, impaired glucose tolerance and hyperinsulinemia compared to diet alone. Xenical is an inhibitor of gastric and pancreatic lipases -- enzymes that play a pivotal role in the absorption of dietary fat. Experts agree that excess caloric intake is a significant component in the development of obesity, and for many people, excess dietary fat is the largest component of this caloric excess. The action of Xenical against lipases blocks the absorption of approximately 30% of the fat eaten in food, which provides an additional caloric deficit for weight loss and control. In clinical trials, no major adverse side effects were noted. The most common effects reported were non-systemic and were primarily gastrointestinal, the majority of which were generally mild and temporary and frequently seen among patients who did not follow the appropriate diet regimen. In the U.S., more than 70 million Americans are considered to be overweight and obese and are at high risk for hypertension, cardiovascular disease, non-insulin dependent diabetes, dyslipdemia, hyperinsulinemia and hypercholesterolemia. As little as 5% reduction in patients' weight improves their health outcomes significantly. Headquartered in Nutley, New Jersey, Hoffmann-LaRoche Inc. is an affiliate of the multinational group of companies headed by Roche Holding Ltd. of Basel, Switzerland. One of the world's leading research-intensive companies, Roche has discovered, developed and introduced numerous important prescription pharmaceuticals. The company's commitment to metabolic research and development stems from its recognition of obesity as a chronic disease needing long-term therapy. In addition to Xenical, Roche, is pursuing investigation of the OB receptor and is supporting gene therapy research through its collaboration with the biotechnology company, Millennium. |
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