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 |
