To: Dan Spillane who wrote (508 ) 11/11/1998 7:53:00 PM From: Anthony Wong Read Replies (3) | Respond to of 2539
Monsanto Drug Works as Well as Voltaren in Rheumatoid Arthritis Bloomberg News November 11, 1998, 6:33 p.m. ET Monsanto Drug Works as Well as Voltaren in Rheumatoid Arthritis San Diego, Nov. 11 (Bloomberg) -- Monsanto Co.'s painkiller Celebrex is less likely to cause ulcers than a common arthritis medicine and appears to work as well in treating a severe form of the disease, a study indicates. The findings will help Monsanto's introduction next year of the new painkiller, the first in a new class of drugs targeted at arthritis. Separately today, Monsanto announced plans to raise as much as $5 billion and cut costs, in part to prepare for the expense of marketing Celebrex. Monsanto, and rival Merck & Co., the world's largest drugmaker presented studies of similar experimental arthritis medicines at the American College of Rheumatology's annual meeting in San Diego. Merck, which is about six months behind Monsanto in developing its drug, has yet to present similar large- scale tests on ulcers, which can cause bleeding. Celebrex ''is going to be a blockbuster,'' said Roy Altman, a professor of medicine at the University of Miami School of Medicine, who has worked in rheumatology for 30 years. ''It's not better than what we have. It's just safer.'' Monsanto fell 1/2 to 38 11/16. In the study, Monsanto compared its drug to diclofenac, sold by Roche Holding AG as Voltaren. Of the 655 patients in the study, 430 underwent endoscopy to check for ulcers in their gastrointestinal tracts. In endoscopy, a device is inserted through the throat to let doctors examine the stomach. Non-Symptomatic That method is necessary because many patients don't realize they have ulcers. ''Gastroenterologists have told us that the real significant GI events -- ones that can lead to death -- are 80 percent non-symptomatic,'' said Mary Lonien, a Monsanto researcher. Merck has done studies based on endoscopic examinations, but said its results weren't ready by the conference's publication deadline. ''That information is what everyone is seeking at this point, but we just don't have it,'' said Kyra Lindemann, a Merck spokeswoman. Merck and Monsanto could be competing by the end of next year in a market for painkillers, estimated at as much as $8 billion in annual sales. They also could steal share from arthritis drugs, such as Voltaren. This Roche version of diclofenac had $1.1 billion in 1997 sales, the company said. The drug also is sold in generic versions. About 4 percent of the 212 patients on Monsanto's drug had signs of gastroduodenal ulcers, or losses of the protective coating against the stomach's acid. In the diclofenac group, about 15 percent of the 218 patients, had these signs. Rheumatoid arthritis is a more severe form of the disease, affecting about 2 million people in the U.S. Many people with the disease have to use wheelchairs and some are forced to stop working. Monsanto also is testing Celebrex in treating the more common form of arthritis, osteoarthritis. An U.S. Food and Drug Administration advisory panel will hold a hearing on Monsanto's drug on Dec. 1. Marketing With Pfizer St. Louis-based Monsanto could introduce Celebrex in early 1999, working with Pfizer Inc. as a marketing partner. Rival Merck & Co., the world's biggest drugmaker, is working on a similar drug, Vioxx. The drugs are the first of a new class, called Cox-2 inhibitors, that are expected to top $1 billion each in annual sales. Some analysts estimate the drugs could top $5 billion combined in sales. The Cox-2 drugs target compounds in the body linked to pain and swelling more specifically than existing painkillers, such as aspirin and ibuprofen. The Cox-2 drugs interfere with the production of the enzyme, cyclooxygensase-2, linked to pain and swelling. Ibuprofen drugs, such as Advil and Motrin, and aspirin interfere with this enzyme and a related one, cyclooxygenase-1, which appears to help protect the stomach from its own acids. As a result, long-term use of existing painkillers causes stomach bleeding and other side effects in some patients. --Jim Finkle in San Diego and Kerry Dooley in Washington through