Abbott Says Data Confirms Arthritis Drug Promise

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Abbott Says Data Confirms Arthritis Drug Promise

Fri Jun 14, 6:35 AM ET

By Woodman

STOCKHOLM (Reuters) - Abbott Laboratories Inc said on Friday latest trial

results confirmed the safety and efficacy of a potential blockbuster

rheumatoid arthritis drug that Britain's Cambridge Antibody Technology Plc

helped discover.

D2E7, which Abbott filed for regulatory approval in April, is one of a new

class of injectable antibody drugs designed to block a protein called tumor

necrosis factor (TNF) involved in inflammation.

The U.S. healthcare group expects peak annual sales in excess of $1 billion

within four to five years of launch, helped by the product's more convenient

dosing regime compared to rivals.

Cambridge Antibody will receive a five percent royalty on eventual sales of

D2E7, which is the first monoclonal antibody made entirely from human

protein, minimizing the risk of side effects. Current drugs are either

man-made or made with a portion of mouse protein.

As with all therapies for rheumatoid arthritis, safety is a key concern, and

Abbott gave results, from a major trial carried out specifically to address

this issue, at the European League Against Rheumatism meeting in Stockholm.

The pivotal Phase III STAR (Safety Trial of Adalimumab in Rheumatoid

Arthritis) trial, involving 636 patients, showed that after 24 weeks of

therapy, there were no statistically significant differences in rates of

adverse events or infections between placebo and D2E7.

Patients in the study were taking up to four disease modifying

anti-rheumatic drugs (DMARDs) when they were randomized to receive

subcutaneous injections of either placebo or D2E7 every other week, in

addition to their DMARDs.

The only adverse events that differed significantly between D2E7 and placebo

were injection site reactions, rash and back pain, the company said.

" What you see here is one of the largest safety trials, " Hoffman,

associate medical director at Abbott, said in an interview. " It mimicked

natural practice for rheumatologists, so patients could be on any DMARD when

they came into the trial. "

Rheumatologists have expressed concern recently that even the latest -2

inhibitors -- while much safer on the stomach than traditional aspirin-like

anti-inflammatory drugs -- might be linked with increased risk of heart and

kidney problems.

Hoffman said all adverse events, including severe or life-threatening ones,

were considered in the trials of D2E7.

Overall, the percentage of adverse events was 86.5 percent in the drug group

compared with 82.7 percent in the placebo arm.

Effectiveness of D2E7 was also measured on the basis of symptomatic relief,

with significantly more patients on D2E7 experiencing an improvement

compared to placebo.

" Based on the number of patients who have taken D2E7 and the number of

studies we've completed, we are confident in the safety and efficacy

profiles, and the convenience D2E7 may offer patients with RA, " said Jeff

Leiden, chief operating officer of Abbott's pharmaceutical products group.

The company said one-year results from another Phase II study showed that 89

percent of patients elected to remain on D2E7 therapy for more than one

year.

Schiff, clinical professor of medicine at University of Colorado

School of Medicine and a lead investigator for the clinical trials, said:

" The Phase III data for D2E7 offer patients hope for a potential new option

that has demonstrated favorable clinical results with convenient dosing and

administration. "