Merck, Searle To Unveil Promising Results Of 2 Arthritis-Pain Drugs
November 10, 1998 1:07 AM
By Thomas M. Burton and Robert Langreth, Staff Reporters of The Wall
Street Journal
The pain wars begin Tuesday.
At a rheumatologists' meeting in San Diego, two drug giants are
expected to present highly promising results from clinical trials on two
competing drugs for arthritis pain. On one side is Merck & Co.'s Vioxx.
On the other is Celebrex, from Monsanto Co.'s Searle unit. At stake is
the business of the many millions around the world afflicted with arthritis.
Merck badly needs a Vioxx success to prevent a revenue shortfall when
several of its cardiovascular drugs lose patent protection starting in 2000.
Searle, meantime, has signed a deal with another drug heavyweight,
Pfizer Inc., to help promote Celebrex. Analysts estimate Pfizer already
has paid Searle a whopping $240 million for those marketing rights --
even though the Food and Drug Administration probably won't approve the
drug until early next year. Merck's Vioxx is expected to hit the market a
few months later.
The pain relievers, both in a new class of drugs called COX-2 inhibitors,
are intended to help thousands of patients avoid the dangerous,
sometimes fatal, bleeding ulcers associated with existing arthritis-pain
drugs. Hemant K. Shah, a drug-industry analyst, estimates that the
market for this new class of drugs could reach $3 billion annually by
2001. Drug analysts estimate that over 100 million people world-wide
suffer from various forms of arthritis, including about 37 million in the U.S.
alone.
As the two drug companies square off, a separate battle will pit both of
them against the managed-care industry. Because the COX-2 drugs are
expected to cost several dollars a pill, managed-care insurers are
debating how to cover them.
The big health-maintenance organizations are staring nervously at an
aging, active population that's ripe for arthritis. And drug makers are
expected to pitch the products far beyond the ranks of arthritis patients
to people with more ordinary aches and pains. Merck is testing Vioxx on
women with severe premenstrual symptoms, as well as patients with
dental pain. Searle has tested its drug on various types of nonarthritis
pain. Insurers contend these people might do just fine with less
expensive medications like aspirin or ibuprofen.
"These drugs could be bad news if the docs go wild," says Fred
Teitelbaum, vice president of Express Scripts/Value Rx, St. Louis, a
company that handles drug prescriptions for big employers. "We worry
about people going in for a sprained ankle and getting a COX-2 inhibitor."
Some managed-care officials say they might insist that patients start on
less expensive medicines like ibuprofen, or even on existing prescription
drugs like Naprosyn, Relafen or Daypro. But it's very difficult to pinpoint
which patients may wind up in a hospital because of a bleeding ulcer.
The medical results for the new drugs, disseminated in written abstracts
at the San Diego conference, look compelling so far. These reports,
whose details will be expounded on at the conference beginning
Tuesday, show that Celebrex, formerly called Celebra, and Vioxx have
distinct safety advantages over existing drugs like Naprosyn and
Voltaren. Only 4% to 6% of 693 Celebrex rheumatoid-arthritis patients
had stomach ulcers in one clinical trial. The rate varied depending on
dosages.
By contrast, 26% of patients taking Naprosyn got such ulcers. Another
large study of nearly 800 osteoarthritis patients found that patients who
received Merck's Vioxx were far less likely to drop out because of side
effects than those receiving Voltaren. (Meanwhile new data show that a
genetically engineered arthritis drug from Centocor Inc. provides relief
from rheumatoid arthritis.)
On the convention-center floor Monday, doctors swarmed booths
operated by Searle, Merck and Boehringer Ingelheim AG, another
company researching COX-2 inhibitors. Searle offered literature about the
mechanism of its drug in French, English, Spanish, Portuguese and
Italian. At Merck's elegant, wood-paneled exhibit, doctors were treated to
free cappuccino and reproductions of paintings by French artist Raoul
Dufy, who suffered from severe rheumatoid arthritis.
A large sign hanging at the Boehringer Ingelheim booth asked: "The COX
hypothesis: Is there more to know?" This refers to proteins, known in
abbreviated form as COX-1 and COX-2, that play a role in producing
inflammation. Aspirin and other existing drugs that target COX-1 can
cause ulcers and other gastrointestinal ailments.
For all the hype, the COX-2 drugs aren't more effective at relieving pain
than existing drugs, according to the abstracts. Patients who don't suffer
side effects should be able to get just as much relief from less expensive
medications. Some patients with osteoarthritis -- the wearing down of the
joint with age and the most common form of the disease -- may get just
as much relief from over-the-counter Tylenol, which doesn't cause ulcers.
"It's an advance in safety, not an advance in effectiveness," says David
Fox, a University of Michigan physician. "I don't think it will be necessary
for most patients with osteoarthritis to take prescription drugs."
Overall, about 1% to 3% of patients who take existing drugs known as
NSAIDs (non-steroidal anti-inflammatory drugs) for a year develop
significant ulcers. Marsha C. Moore, chief medical officer of the PCS
drug-benefits managing company owned by Eli Lilly & Co., estimates
there are about 80,000 hospitalizations annually from such
gastrointestinal side effects. Moreover, she says, about 8,000 people die
from these side effects yearly. She says the cost of treating the side
effects is greater than the cost of treating arthritis itself.
Side effects of existing drugs are believed less common among younger
patients and those with osteoarthritis. One large study to be presented at
the San Diego meeting pegs the annual rate of ulcers requiring
hospitalization at about 0.5% for osteoarthritis patients, about half that
seen with rheumatoid patients. Moreover, the severe side effects are
unlikely to appear in those who take drugs for periods of less than two
weeks at a time. Hence, millions use aspirin for occasional pain without
problems.
Copyright (c) 1998 Dow Jones & Company, Inc.
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