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WASHINGTON–(BUSINESS WIRE)–Today, the Biotechnology Innovation Organization (BIO) released a new
report, The
State of Innovation in Highly Prevalent Chronic Diseases Volume IV:
Alzheimer’s Disease Therapeutics
, the fourth in a series on the
innovation landscape of highly prevalent, chronic diseases. This volume
takes an in-depth look at the state of innovation for therapeutics in
Alzheimer’s disease, which is expected to affect more than 13.8 million
people in the United States by 2050 and cost well over $1 trillion

”The growing health and financial impact of Alzheimer’s disease on
American patients, caregivers, and our healthcare system makes the need
for new treatments more pressing each day,” said BIO President and
CEO Jim Greenwood.
“The good news is that America’s
biopharmaceutical companies currently are conducting 74 clinical-stage
programs intended to stop, prevent, or slow the progression of this
looming crisis. The bad news is that, while these programs hold real
promise, the R&D challenges with this disease are enormous and the level
of investment and innovation is not where our nation needs it to be to
address this exploding public health crisis. To win this fight, it is
essential that our public policies stimulate more investment in research
and innovation.”

The analysis, which aims to assess the depth and breadth of innovation
to meet the needs of patients suffering from Alzheimer’s disease, also
features historical clinical success rates, failed mechanistic
strategies, as well as trends in venture financing and investment into
new clinical trials.

Key Takeaways

  • Lack of Approved Drugs: There are currently no FDA-approved
    disease-modifying drugs for Alzheimer’s disease.
  • Insufficient Venture Investment: Venture capital funding of
    U.S. companies with lead programs in Alzheimer’s disease is 16 times
    below oncology funding ($1.0 billion vs. $16.5 billion over the last
  • Poor R&D Success Rates: Clinical development success for
    disease-modifying drug programs for Alzheimer’s has been difficult in
    late-stage trials, with no disease-modifying drugs moving beyond Phase
    III to FDA filing. Since 2008, a total of 87 clinical-stage
    disease-modifying programs have been suspended.
  • Inconsistent Clinical Trial Initiations: Clinical trial starts
    for disease-modifying Alzheimer’s drugs have ranged from 11-21 trial
    starts per year since 2008, with no detectable trend. Phase III trial
    starts have been the least consistent, ranging from 0-5 per year.
  • Growing & Diverse R&D Pipeline: There are 74
    clinical-stage programs with disease-modifying potential in
    Alzheimer’s disease. The drug candidates in these programs are
    attempting to stop, prevent, or slow the progression of Alzheimer’s
    disease using 10 different strategies involving 30 distinct molecular
    targets. Small biotech companies account for more than three-fourths
    of these clinical programs.

“With a 100% failure rate for disease-modifying Alzheimer’s Phase III
studies, this has been the most challenging R&D hurdle in our industry.
The combination of a looming crisis in Alzheimer’s-associated healthcare
costs and no disease-modifying drug on the market indicates a desperate
need for higher levels of investment and innovative approaches,” said
report author David Thomas, Vice President, Industry Research for BIO
“This report shows the venture investment trend is positive, but still
significantly lower than other therapeutic areas such as cancer. The
biopharmaceutical industry is working hard to make progress, with the
majority of targeted therapeutics entering the clinic being conducted by
small companies. A more supportive policy environment will be critical
to developing new treatments that could improve the lives of the
millions of patients and families suffering from this disease.”

The report and other BIO Industry Analysis reports are available for
download here:

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