By the end of the month, a Cowen and Co. analyst says, Wyeth and Elan Corp. PLC will report clinical trial data for a new kind of Alzheimer's disease treatment _ one that could slow the progress of the disease rather than fighting its symptoms.
Analyst Ian Sanderson calls the test results for bapineuzumab "one of the most anticipated phase II trials in pharmaceutical industry history." He expects Elan and Wyeth to report their findings by the end of June.
The Alzheimer's treatment market is led by four drugs: Pfizer Inc.'s Aricept, Forest Laboratories Inc.'s Namenda, Razadyne from Johnson & Johnson and Shire Ltd., and Novartis AG's Exelon. Those drugs fight the symptoms of Alzheimer's disease _ for example, Aricept is thought to slow the damage done to thinking and memory _ but can't stop its ultimate progress.
"The reason there's so much interest in this particular agent, bapineuzumab, is it could be the first drug to change the course of Alzheimer's disease," Sanderson said in a telephone interview.
In Alzheimer's disease, a naturally occurring protein is broken down into component parts called peptides. A peptide called beta-amyloid 42 is toxic and forms plaques that can kill neurons in the brain. But bapineuzumab binds to those proteins, Sanderson said, allowing them to be cleared out of the brain.
Sanderson thinks the phase II trial is going to be modestly disappointing. It's too small and uses too many different doses to achieve its main goal, he said _ but the trial will still indicate that the drug works, and he thinks late-stage trial data will be clearer.
The analyst expects Elan and Wyeth to report phase III results in mid-to-late 2010, with the drug approved for sale the following year, around a year and a half before similar competitors. He said sales could peak at about $7 billion worldwide.
The total market for Alzheimer's treatments could be more than $10 billion to $12 billion, Sanderson said. That compares with about $2.7 billion for the four current top drugs.
Eli Lilly is working on two other Alzheimer's candidates, including LY450139. But Sanderson said that drug has been linked to ulcers and gastrointestinal bleeding, which could complicate the approval process. The Food and Drug Administration does not seem concerned about the safety of bapineuzumab, although Sanderson said some trial patients have experienced a fluid buildup in the brain.
Pfizer has an antibody, like bapineuzumab, early in clinical development.
In afternoon trading, shares of Wyeth dipped 22 cents to $43.20, and Elan stock rose 74 cents, or 2.8 percent, to $27.01.
Shares of Eli Lilly picked up 34 cents to $47.99.
Pfizer shares declined 14 cents to $17.85.
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