WASHINGTON, March 31, 2016—Today’s Alzheimer’s disease drug pipeline, marred by more than a decade of high failure rates and public underinvestment, is offering near-term promise with 17 drugs on pace to launch in the next five years, according to a recent analysis conducted by ResearchersAgainstAlzheimer’s (RA2), an UsAgainstAlzheimer’s (UsA2) network. If only some of those drugs are successful in late-stage trials and cleared by the U.S. Food and Drug Administration (FDA), the potential innovations will be a much-needed stimulus to the goal of stopping America’s most costly disease, one that affects approximately 5.3 million Americans, a number that is expected to rise precipitously during the next few decades.

Findings from the analysis underscore an important question: once the therapies are approved, will those affected by the disease be able to access these drugs?

“Despite the recent history of disappointment for Alzheimer’s disease advancements, we are cautiously optimistic about the progress of this next wave of innovation because we are seeing well-funded trials and concerted efforts to learn from past failures,” said Dr. David Morgan, a founding member of RA2, a distinguished professor of the College of Medicine and Molecular Pharmacology and Physiology at the University of South Florida, and CEO of the Byrd Alzheimer's Institute.
“The analysis confirms that while there is a promising pipeline for Alzheimer’s patients, we must, in parallel, be encouraging more physicians to accurately diagnose and treat this disease, and work with insurers to enable access for patients to these new drugs when they are available.”

According to the RA2 analysis, there are currently 17 Alzheimer’s drugs in Phase 3 clinical trials on course to launch in the next five years. This first-of-its-kind analysis reached its conclusions following extensive examination of SEC filings, company reports, presentations at medical conferences, media releases and interviews with company executives about publicly available information on drugs in late-stage testing. In addition, academic research experts and select RA2 members provided input and review of the analysis.

In the United States, Alzheimer’s, the most common form of dementia, is the third leading cause of death, according to recent studies. Among the top 10 causes of death, it’s the only one that currently can’t be prevented, stopped or slowed. The RA2 analysis’ findings provide the hope that is sorely needed for Alzheimer’s patients and their numerous caregivers who have not seen a novel Alzheimer’s therapy since 2003, when Namenda was approved by the FDA.

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