Study shows prognosis encouraging for Abbott drug - more on D2E7 including a price range estimate

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Study shows prognosis encouraging for Abbott drug

BRUCE JAPSEN

Published October 17, 2002

Even though Abbott Laboratories will begin temporarily giving its

experimental rheumatoid arthritis treatment to patients for free, the

drug could be taking a major step toward generating blockbuster sales.

As part of a federally approved study, the North Chicago-based

medical-products giant will soon begin providing early access to its

promising drug D2E7 for patients who do not respond to other rheumatoid

arthritis treatments.

Such studies allow greater access to experimental treatments that are

nearing Food and Drug Administration approval. They expand access to

drugs for which there are few treatments, such as AIDS or certain

cancers.

" As we have done with other therapeutic areas, we remain committed to

developing and making promising treatments available to patients in

need, " said Dr. Leiden, Abbott's president and chief operating

officer, pharmaceutical products group.

The study is also a marketing coup for Abbott because the company will

begin building brand loyalty to D2E7 from the more than 250 physicians

and their 5,000 patients expected to enroll in the project by

year-end,analysts say.

" The advantage is that Abbott's product gets physician and patient

familiarity, paving the way for a more rapid uptake once the product is

actually approved, " said Abramowitz, analyst with the Carlyle

Group in New York.

Once the drug is formally approved by the FDA sometime next spring, D2E7

will no longer be freebecause the treatment will no longer be considered

experimental, a status insurers typically shy away from covering. The

drug is expected to cost $10,000 to $12,000 a year, according to

analysts' estimates.

With Abbott's third-quarter sales up only 3.8 percent to $4.34 billion,

Wall Street anxiously awaits new life in company revenues. D2E7 is

expected to eventually generate annual sales of $1 billion, a magic

number Wall Street uses to measure blockbuster status of drugs.

D2E7 has been shown in earlier clinical trials to actually slow

progression of the debilitating disease. By allowing even more patients

to use the drug, analysts say, the FDA is sending Abbott a message that

D2E7 is safe and effective.

" The [study] is particularly encouraging to us . . . because it signals

the FDA has a positive bias toward the data and thus the approval

timelines appear solid, " Deutsche Bank analyst Bruce s said in a

recent report.

Polyheme plan: Northfield Laboratories Inc. said Wednesday it will

submit a plan to the Food and Drug Administration for testing its

experimental blood substitute in trauma patients.

The proposed trial for Polyheme is designed to broaden the product's use

by testing it on severely injured patients while they are transported by

ambulance to the hospital.

The trial is critical to whether the ton-based biotech company will

ever be able to market Polyheme, which has been in development for 17

years.

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