Elan, Wyeth plan advanced trials of drug

Ireland's Elan Corp. PLC and Wyeth of the United States said Monday they are planning advanced trials of a drug to combat Alzheimer's, the incurable brain disease that afflicts more than 20 million people worldwide.

The pharmaceutical companies are seeking regulatory approval to begin advanced "phase 3" trials of bapineuzumab, which they hope will eventually be used to stop the memory loss and dementia symptomatic of Alzheimer's.

Both companies said they plan to begin advanced studies in the second half of 2007 — several months ahead of their previous target — but do not expect to announce results from their current mid-stage, "phase 2" trials until 2008.
"It is important to remember that Alzheimer's disease is a complex and formidable challenge, and our immunotherapeutic programs still contain inherent risks," the companies cautioned.

Shares of Dublin-based Elan surged 20 percent, to close at a new 52-week high of $18.95 on the Irish Stock Exchange. Wyeth shares were up $1.52, or 2.7 percent, at $57.90 in midday trading.

Analysts said the surprise decision to accelerate the advanced clinical trials for bapineuzumab raised investors' confidence that the drug was on course for U.S. Food and Drug Administration approval in 2008.

"The Alzheimer's market is huge," said Ian Hunter, an analyst at Goodbody Stockbrokers in Dublin. "It has the potential to be the next big indication for pharmaceutical companies, especially as the baby boomers come into the Alzheimer's-prone age group."

Several biotechnology companies are racing to develop the first FDA-approved drug that can effectively stop the development of amyloid plaques in the brain, which is believed to be the root cause of Alzheimer's.

While current drugs for Alzheimer's sufferers are administered to suppress symptoms, the new experimental drugs seek to prevent, or remove, the plaque formations.

Among rivals for the Elan-Wyeth project are Myriad Genetics Inc., whose Flurizan drug is already in phase 3 trials, and Medivation Inc., which expects its Dimebon drug to reach that level in 2008. Memory Pharmaceuticals Corp. expects phase 2 results of its drug, MEM 1003, in late 2007.

The current Elan-Wyeth trials of bapineuzumab involve treating 240 people with mild to moderate cases of Alzheimer's, chiefly in the United States, over an 18-month period, and a separate study of 30 Alzheimer's sufferers in Europe.