The Wall Street Journal-20080130-Baxter Drug Poses Supply Issue
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Baxter Drug Poses Supply Issue
Full Text (636 words)Baxter International Inc. says it believes that it will be able to supply the market for Alzheimer's treatments if its Gammagard intravenous drug proves effective against the disease.
Efforts are under way to evaluate whether Gammagard, a decades-old Baxter drug now used to treat malfunctioning immune systems, could be used as an effective Alzheimer's treatment. The prevalence of the memory-robbing disease is expected to balloon as Baby Boomers age, creating a big market for any drug that appears effective. Measuring Alzheimer's progression and symptoms is highly subjective. Treatments now on the market can merely delay the worsening of symptoms.
Gammagard has generated some Alzheimer's interest with a positive but very small and very early-stage study. If it is found useful, one catch would be making enough of it. Gammagard is a human-derived product that researchers believe could never meet the demands of the Alzheimer's market. New production methods or creation of a mass- producible related product would likely be needed.
"To be clear, that is something we continue to evaluate," Baxter Chief Financial Officer Robert M. Davis said in an interview after the company issued fourth-quarter results last week. Baxter is "looking at what we have to do to have adequate supplies."
Gammagard is one of multiple intravenous immunoglobulin, or IVIG, drugs that contain vast numbers of natural human antibodies. The theory behind using IVIG for Alzheimer's patients is to replenish what may be a depleted stock of antibodies that can remove a brain-harming plaque associated with the disease.
The Gammagard research has drawn interest in part because it is a widely known product used for years. There may be a way to tackle the supply issue, researchers have said, by winnowing out the particularly effective antibodies within the drug and using them to fashion a new Alzheimer's-fighting weapon.
Mr. Davis declined for competitive reasons to say what methods Baxter might employ to create enough product for the Alzheimer's market, which the company is still years away from serving, but said Baxter believes it can address the issue.
"I do believe that we are confident that assuming demand for the product is there . . . we will be in a position" to serve the market, Mr. Davis said. Baxter also has said that it is committed to ensuring supplies for existing Gammagard patients.
Baxter said in late August last year that preliminary results from a Phase II study on the treatment of Alzheimer's were encouraging enough to trigger the launch of a more comprehensive Phase III study. Phase III studies are generally used to generate the kind of evidence needed to secure regulatory approval, which could happen in a few years for Baxter if the research progresses well.
Efforts on the Phase III study are under way, although the study hasn't started enrolling patients yet, Mr. Davis said.
Full results from the earlier double-blind, placebo-controlled Phase II study, which involved only 24 patients, have yet to be unveiled. Baxter said in its earnings release that it anticipates a presentation in the second quarter, but Mr. Davis cautioned that the timing is up to Norman Relkin, who is researching the issue with colleagues and directs the Memory Disorders Program at New York-Presbyterian Hospital/Weill Cornell Medical Center. Dr. Relkin is looking for the medical conference that will offer the best opportunity for releasing the data, Mr. Davis said.
He added that progress on the Phase III study is in no way impeded by the wait for full Phase II information.
Research on Gammagard is one of several efforts under way in the hunt for new ways to battle the disease. Another big effort on the antibody front is a partnership between Wyeth and Elan Corp. They announced in December that the first patient in North America had been dosed as part of a global Phase III program.
