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AstraZeneca: Update on Phase III clinical trials of lanabecestat for Alzheimer's disease

Independent data monitoring committee advises lanabecestat is unlikely
to meet primary endpoints, leading to decision to discontinue these

AstraZeneca and Eli Lilly and Company (Lilly) are discontinuing the
global Phase III clinical trials of lanabecestat, an oral beta
secretase cleaving enzyme (BACE) inhibitor, for the treatment of
Alzheimer's disease. The decision is based on recommendations by an
independent data monitoring committee (IDMC), which concluded that
both the AMARANTH trial, in early Alzheimer's disease, and the
DAYBREAK-ALZ trial, in mild Alzheimer's disease dementia, were not
likely to meet their primary endpoints upon completion and therefore
should be stopped for futility. As a result of this decision, the
related AMARANTH extension trial will also be discontinued.

Menelas Pangalos, Ph.D., Executive Vice President, IMED Biotech Unit,
AstraZeneca said: "We are saddened by this outcome as our researchers
are working tirelessly to find a solution for the many people who are
impacted by this devastating disease. We are committed to ensuring
our findings can be used to inform further research in the
Alzheimer's community, given the importance of finding a treatment
for this disease."

The IDMC recommendation to stop the studies was not based on safety
concerns. The AstraZeneca and Lilly BACE alliance for lanabecestat
remains in place and the companies will now work with the clinical
trial sites involved to implement the discontinuations.

"The complexity of Alzheimer's disease poses one of the most difficult
medical challenges of our time, and we are deeply disappointed for
the millions suffering from this devastating disease," said Daniel
Skovronsky, M.D., Ph.D., president of Lilly Research Labs. "We are
grateful for the contributions of the study participants and their
families and encourage them to consider other Alzheimer's disease
clinical trials. Lilly remains dedicated to Alzheimer's disease
research as we have been for the last three decades. We won't give up
on finding a solution for Alzheimer's patients."

The AMARANTH trial randomised patients with early Alzheimer's disease
to receive lanabecestat, 20mg or 50mg, or placebo orally once daily
for 104 weeks. The primary endpoint of the trial was change from
baseline on the 13-item Alzheimer's Disease Assessment
Scale-Cognitive Subscale (ADAS-Cog13). Early Alzheimer's disease is
defined as the continuum of patients with mild cognitive impairment
due to Alzheimer's disease and patients diagnosed with mild
Alzheimer's disease dementia. Patients who completed the AMARANTH
trial were given the opportunity to enrol in the AMARANTH extension
trial, where all patients received active treatment.

The DAYBREAK-ALZ trial randomised patients with mild Alzheimer's
disease dementia to receive either lanabecestat, 20mg or 50mg, or
placebo orally once daily for 156 weeks. The primary endpoint of the
trial was change from baseline on ADAS-Cog13.

Financial considerations

The discontinuation of the lanabecestat Phase III clinical trials in
Alzheimer's disease is not expected to have a material impact on the
Company's financial guidance for 2018, which therefore remains

- ENDS -


About Alzheimer's disease

Alzheimer's disease is a fatal illness that causes progressive decline
in memory and other aspects of cognition.1 Dementia due to
Alzheimer's disease is the most common form of dementia, accounting
for 60 to 80 percent of all cases.2 There are currently an estimated
50 million people living with dementia around the world, with numbers
expected to increase to nearly 75 million by 2030 and 132 million by
2050. Almost 10 million new cases of dementia are diagnosed each year
worldwide, implying one new case approximately every three seconds.3
The current total annual societal and economic estimated cost of
dementia is $818 billion USD worldwide and this year may rise above a
trillion USD.3

About the AstraZeneca and Lilly BACE Alliance

AstraZeneca and Lilly announced an alliance in 2014 for the
development and commercialisation of lanabecestat. It was agreed that
Lilly would lead clinical development, working with researchers from
AstraZeneca's Research and Development Team, while AstraZeneca would
be responsible for manufacturing.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery
to make life better for people around the world. We were founded more
than a century ago by a man committed to creating high-quality
medicines that meet real needs, and today we remain true to that
mission in all our work. Across the globe, Lilly employees work to
discover and bring life-changing medicines to those who need them,
improve the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at and

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal & Metabolism
and Respiratory. The Company also is selectively active in the areas
of autoimmunity, neuroscience and infection. AstraZeneca operates in
over 100 countries and its innovative medicines are used by millions
of patients worldwide.

For more information, please visit and follow us
on Twitter @AstraZeneca.

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1 Alzheimer's Association. What is Alzheimer's?
Accessed April 2018.

2 Alzheimer's Association. What is Dementia? Accessed April 2018.

3 Alzheimer's Disease International. Dementia Statistics. Accessed April 2018.


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