NEW RA DRUG HUMIRA RIVAL TO REMICADE & ENBREL??

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Biotech Watch

New arthritis drug may take sales from blockbuster Enbrel

By

Bloomberg News

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NEW ORLEANS — Two years ago, Alan got the flu and never really

recovered. The illness was followed by the onset of rheumatoid arthritis,

which swiftly transformed the university professor's life.

As the inflammatory disease attacked 's joints, the one-time runner,

swim coach and concert-trained pianist says he was reduced to a painful

shuffle and unable to carry out many simple daily activities.

" I was 52 years old and I couldn't peel a banana, " said , who teaches

statistics at the University of Wyoming.

Then enrolled in a University of Colorado study of D2E7, an arthritis

medication from Abbott Laboratories that's currently under review at the U.S.

Food and Drug Administration.

hasn't been told officially whether he received the placebo treatment

or Abbott's drug, also known as Humira, though both he and his doctor say the

results were so striking that they are sure he was getting Humira.

" I'm very active now — as much if not more so than I was before, " said ,

who has gone back to playing, coaching and running. " It was magic; I was

given a new life. "

If approved by the FDA, Humira would compete with & 's

Remicade and Amgen's Enbrel in a rheumatoid-arthritis market expected to have

sales of $5 billion a year by 2005.

Abbott, which discovered the drug with Britain's Cambridge Antibody

Therapeutics Group, is poised to unveil Humira early next year and will be

counting on data from patients like to sell arthritis doctors on the

newest drug.

Called anti-TNF agents, all three medicines stop overactive immune systems

from damaging joints and appear able to slow the long-term damage caused by

the disease.

Since their introduction in 1998, TNF drugs have transformed rheumatoid

arthritis from a disease that crippled half its victims within 10 years to

one that may be manageable for a lifetime.

Doctors said they were impressed with key data on Humira that researchers

discussed here during a special session this weekend at the American College

of Rheumatology's annual meeting. According to the research, patients in a

group taking the highest dose of the medicine were less likely to suffer

cartilage and bone erosion at the end of one year than patients treated with

a placebo.

The data looks strong enough to help Abbott win market share when the drug is

approved, analysts and investors said.

" Its going to be a battle, " between Enbrel and Humira, said King, a

biotechnology analyst with Banc of America Securities, who has a " buy " rating

on Amgen.

According to analysts, Humira has sales potential of about $1 billion a year.

The market for all arthritis medicines is growing faster than total

pharmaceutical sales, and Amgen and & have already tested

their medicines in other conditions, such as psoriasis, psoriatic arthritis,

and a disease called ankylosing spondylitis, which attacks the neck and

spine.

Rheumatoid arthritis strikes about 1 percent of the population, causing

swelling in the joints that may lead to bone erosion and disability. More

women than men suffer from the illness, which usually hits patients in their

mid-40s.

Patients can self-inject Humira once every two weeks. That may give it an

advantage over Enbrel, which patients inject themselves twice weekly.

Remicade is given through an intravenous infusion in a doctor's office.

" Enbrel has the leadership advantage, but Humira is going to be a challenge.

It's big, " said van den Broek, a fund manager for Hill

Partners who doesn't own either Abbott or Amgen.

Doctors at the meeting said Enbrel is likely to remain their first choice, at

least initially, because more is known about its long-term benefits and

safety.

" I'll use Enbrel because I know it is safe, " said Dr. Molly Fainstat. " But if

(Humira) winds up better or cheaper, I might try it. "

Rheumatologists say they are unlikely to switch an existing patient away from

a successful treatment. But manufacturing problems have led to a shortage of

Enbrel that may not disappear until just before Humira hits the market.

While no head-to-head studies have been done, investors and doctors who

attended the meeting's standing-room-only session on Humira said the

medicine's initial benefit appears to be about as good as Enbrel's.

Along with the added convenience Humira offers, the strong data so far means

many patients who are waiting for treatment may consider Humira instead,

doctors said.

" Patients are going to say why do I need to shoot myself twice a week when I

can do it twice a month instead, " said ph Markenson, a rheumatology

expert from New York's Hospital for Special Surgery. " This has put Abbott on

an even playing field. "

Copyright © 2002 The Seattle Times Company