INDIANAPOLIS, Aug. 22, 2016 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and AstraZeneca today announced they have
received U.S. Food and Drug Administration (FDA) Fast Track
designation for the development program in Alzheimer's disease for
AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor
currently in phase 3 clinical trials. The FDA's Fast Track program
is designed to expedite the development and review of new therapies
to treat serious conditions and tackle key unmet medical needs.
"We are pleased the FDA places a high priority on the
development of drugs that target Alzheimer's disease, one of the
most critical health issues of our time," said Phyllis Ferrell, vice president and global
development leader for Alzheimer's disease at Lilly. "Most
importantly, this is a positive step forward for the millions of
patients, families, caregivers, advocates and healthcare providers
who fight every day for progress."
"The Fast Track designation in the U.S. for this
promising potential therapy reinforces the ambition of the
AstraZeneca-Lilly BACE alliance to help advance science for
patients and their families managing this devastating illness,"
said Craig Shering, AZD3293 Project
Lead in Global Medicines Development at AstraZeneca.
"BACE inhibitors have the potential to transform the treatment of
Alzheimer's disease, one of the biggest challenges facing medical
science today."
In addition to the continuing AMARANTH phase 2/3 study, Lilly
and AstraZeneca have also announced the planned initiation of a
second phase 3 trial for AZD3293. The trial, called DAYBREAK-ALZ,
studies the safety and efficacy of AZD3293 in people with mild
Alzheimer's dementia and began enrolling participants in the third
quarter of 2016.
AZD3293 has been shown in studies to reduce levels of amyloid
beta in the cerebro-spinal fluid of people with Alzheimer's and
healthy volunteers. The progression of Alzheimer's disease is
characterized by the accumulation of amyloid plaque in the brain.
BACE is an enzyme associated with the development of amyloid beta.
Inhibiting BACE is expected to prevent the formation and build-up
of amyloid plaque which in turn may help slow the progression of
the disease.
About the AstraZeneca and Lilly BACE Alliance
AstraZeneca and Lilly announced an alliance in 2014 for the
development and commercialization of AZD3293. Under the agreement,
Lilly will lead clinical development, working with researchers from
AstraZeneca's Research and Development Team, while AstraZeneca will
be responsible for manufacturing. The companies will take joint
responsibility for commercialization of the molecule and will share
all future costs equally for development and commercialization, as
well as net global revenues post-launch.
About Alzheimer's disease
Alzheimer's disease is a fatal illness and is the most common
form of dementia, accounting for 60 to 80 percent of
cases.1 There are currently an estimated 46 million
people living with dementia worldwide, and this number is expected
to exceed 74 million in 2030 and 131 million in 2050.2
Only 50 percent of people with dementia ever receive a formal
diagnosis,3 and Alzheimer's disease continues to be one
of the most significant health challenges facing the world. The
total estimated worldwide cost of dementia in 2015 was $818 billion.2 By 2018, dementia
will become a trillion dollar disease, rising to $2 trillion by 2030.2
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 – Respiratory and Autoimmunity, Cardiovascular
and Metabolic Diseases, and Oncology. The company is also active in
inflammation, infection and neuroscience through numerous
collaborations. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.
For more information please visit: www.astrazeneca.com.
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
www.lilly.com and newsroom.lilly.com/social-channels.
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about LY3314814/AZD3293 as a potential treatment for
Alzheimer's disease, and reflects Lilly's current belief. However,
as with any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
Among other things, there can be no guarantee that
LY3314814/AZD3293 will receive regulatory approvals or be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's most recent Form 10-K and Form
10-Q filings with the United States Securities and Exchange
Commission. Except as required by law, Lilly undertakes no duty to
update forward-looking statements to reflect events after the date
of this release.
P-LLY
1 Alzheimer's Association. 2016 Alzheimer's Disease
Facts and Figures. Alzheimer's & Dementia. 2016; 12(4).
2 Prince M, et al. World Alzheimer Report 2015: The
Global Impact of Dementia, An Analysis of Prevalence, Incidence,
Cost and Trends. Alzheimer's Disease International. August 2015.
3 Department of Health. Dementia – a state of the
nation report on dementia care and support in England.
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/262139/Dementia.pdf.
Accessed 8 July 2015.
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Refer to:
Media: Nicole Hebert,
nicole_hebert@lilly.com, +1-317-701-9984
Investors: Phil Johnson,
johnson_philip_l@lilly.com, +1-317-655-6874
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SOURCE Eli Lilly and Company