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Baxter International Inc. (BAX) is pushing up the start time for a second, late-stage study designed to test the company's Gammagard drug as a potential Alzheimer's disease treatment based on positive data in a smaller-scale study.
The opportunity to tap the large and potentially lucrative Alzheimer's market remains years away for the Deerfield, Ill., company, which declined to issue a timeline for the new study. But moving up the launch plan is a positive sign for the program, analysts said.
The smaller-scale study of 24 Alzheimer's patients showed cognitive and functional benefits for those on Gammagard at 18 months compared with patients who initially received a placebo, Baxter announced late Tuesday. Imaging scans also showed benefits for Gammagard patients on measures of brain atrophy and enlargement in the brain.
These data require validation in larger-scale research before Baxter can open up a big, new market, and that entails some risk. Medivation Inc. (MDVN) reported last month that an experimental Alzheimer's treatment in development with Pfizer Inc. (PFE) failed to show effectiveness in a large late-stage study, for example, marking a major setback.
Baxter already has one late-stage study for Gammagard underway, which could produce preliminary results by the second half of 2012. The company previously planned to start the other late-stage study after the first one, which includes 360 patients, but now plans to run them concurrently.
This is being done based on the strength of the smaller study's data, said Hartmut Ehrlich, vice president of research and development in Baxter's BioScience business, in a release.
A Baxter spokesman confirmed Wednesday that the second late-stage study's timeline has been bumped up but said it's too early to say what the timeline might look like. The company needs to discuss the study design with the Food and Drug Administration.
Morgan Stanley analyst David Lewis called Tuesday's data "far from definitive" but said "the decision to run the second Phase III trial concurrently with the first is an important and perhaps positive signal from Baxter."
Alzheimer's is a progressive, brain-damaging disease that is expected to grow in prevalence as baby boomers age. Because there are limited treatment options today, it remains a sought-after market for drug makers.
Baxter is chasing that prize with Gammagard, an existing, decades-old drug made from donated human plasma. It is one of many intravenous immunoglobulin, or IVIG, drugs, and it is commonly used to treat malfunctioning immune systems.
The aim of using the drug against Alzheimer's is, essentially, to replenish what may be a depleted reservoir of natural antibodies that can remove an Alzheimer's-linked substance called beta-amyloid from the brain.
UBS analyst Bruce Nudell said he remains "cautiously optimistic" on the Alzheimer's opportunity for Baxter. William Blair's Ben Andrew estimated Baxter won't receive FDA approval or broad reimbursement coverage before about 2015, suggesting that opportunity is still a distant one.
Baxter shares recently traded 0.5% lower to $58.76.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728; firstname.lastname@example.org