Rheumatoid arthritis drug market heats up
Boston globe:

firms scramble to grab No. 1 spot
By Christopher Rowland, Globe Staff  |  October 14, 2004

The fight over the lucrative market for rheumatoid arthritis drugs is
heating up.

In the last five years, three similar drugs have been introduced that
offer patients the promise of getting back on their feet. Now the
manufacturers of all three are jockeying for market share so they can
be the leader when Medicare's full prescription drug benefit takes
effect in 2006. That will enable millions more seniors to afford their
$15,000-a-year treatments.

The companies are hitting consumers with a barrage of advertisements.
By 2006, the US market for rheumatoid arthritis drugs is expected to
exceed $5 billion, said Bruce Cranna, an analyst at Leerink Swan & Co.
in Boston.

"It's big, it's growing fast, and it's very profitable," he said.

With analysts and scientists taking stock of the rheumatoid arthritis
landscape in advance of a major American College of Rheumatology
conference next week, there also are signs the drugs present small
risks of dangerous side effects, including lymphoma. But the companies
and doctors, while saying doctors should be informed, say the data do
not conclusively prove or disprove dangers.

The newcomer to the race is Abbott Laboratories, which won approval
for its drug Humira, manufactured in Worcester, in late 2002. It says
it is poised to break the $1 billion annual sales barrier next year.
Humira competes against two other blockbuster drugs: Enbrel, which is
marketed jointly by Amgen Inc. and Wyeth, and with Remicade, which is
sold by Johnson & Johnson.

All three drugs suppress a protein in the body known as TNF-a, which
is linked to inflammatory diseases when it is overproduced. Until this
year, Remicade had a clear advantage in the market. Because it is
administered in a doctor's office, it is the only drug of the three to
be covered by federal Medicare health insurance for the elderly.

But after a coordinated lobbying campaign last year by Abbott and
Amgen/Wyeth, Congress approved a pilot program that provides limited
Medicare coverage for Humira and Enbrel, which patients inject
themselves at home. Some rheumatoid arthritis patients (how many has
not been determined) will be covered through a $500 million pot, which
also is available for coverage of self-injected treatments for cancer
and multiple sclerosis. The unusual team approach among competitors
made sense in this case, said Jennifer Taylor McBride, vice president
for public policy and advocacy at the Arthritis Foundation, which also
lobbied for the coverage. "Keeping your enemy close at hand is the
best way to make sure they both get equal coverage," she said.

The pilot program will lead up to the moment when Medicare-related
sales should take off with introduction of the full drug coverage in
2006.

"We really see it as an opportunity for millions of seniors who have
not been able to have a choice of therapy," said Tim Walbert, vice
president and general manager of Abbott's immunology division.
It is unusual for such expensive drugs to be advertised in major
consumer-oriented campaigns. Despite frequent criticism that drug
companies pump up sales unnecessarily through consumer marketing,
Abbott said its consumer advertising is playing a positive role in
healthcare.


"The education can be extraordinarily valuable in helping physicians
and patients in treating the disease," said Jim Bozikis, an Abbott
spokesman.

As part of its rollout strategy for Humira, Abbott has been giving its
drug away free to about 10,000 patients who lack prescription
coverage. Of those, it has encouraged about 1,000 to move into the
Medicare pilot program.

Meanwhile, all three companies are expanding markets by adding to
their roster of treatable diseases. Abbott expects to present academic
papers next week at the American College of Rheumatology that Humira
is appropriate for use in early stages of rheumatoid arthritis and for
psoriatic arthritis.

Johnson & Johnson, which sells Remicade through its Centocor Inc.
subsidiary, won Food and Drug Administration approval to market
Remicade as a first-line treatment for rheumatoid arthritis in
September. That is a key finding that could help the company, doctors,
and patients persuade insurance companies to cover earlier use of the
drug.

But Johnson & Johnson announced a negative development about Remicade
last week, disclosing that a rare side effect of Remicade is lymphoma,
a form of cancer. In August, it also said the drug could cause rare
and potentially fatal blood and nervous system disorders.

Both Humira and Enbrel have listed similar side effects on their
labels since an FDA advisory committee hearing last year, which said
patients and doctors needed a better warning. But the advisory
committee members also said that the data are inconclusive.

A physician at Brigham and Women's Hospital in Boston, Dr. Michael
Weinblatt, who had conducted clinical trials on these drugs, said the
risk of developing lymphoma -- while higher than for the general
population -- has been shown to be the same for someone taking one of
the drugs as it is for someone with untreated rheumatoid arthritis.

"This is a pretty low level of risk, but it is something that patient
and rheumatologists should be aware of," Weinblatt said. "What I tend
to tell my patients is there may be a slight risk of lymphoma with
these drugs, just as there we know there is a slight risk of lymphoma
with the disease."

Visit my website:
http://www.mzuschlag.com