New arthritis drug may take sales from blockbuster Enbrel

NEW ORLEANS — Two years ago, Alan Moore 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 Moore'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 Moore, who teaches statistics at the University of Wyoming.

Then Moore 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.

Moore 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 Moore, 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 Johnson & Johnson'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 Moore 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 Michael 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 Johnson & Johnson 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 Richard van den Broek, a fund manager for Cooper 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 Joseph Markenson, a rheumatology expert from New York's Hospital for Special Surgery. "This has put Abbott on an even playing field."