Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of June
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update:
lanabecestat Phase III Alzheimer's trials
This announcement contains inside information
12 June 2018 07:00 BST
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 trials
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
unchanged.
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 www.lilly.com and
www.lilly.com/newsroom/social-channels.
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 www.astrazeneca.com
and follow us on Twitter
@AstraZeneca.
|
Media
Relations
|
|
|
|
Karen
Birmingham
|
UK/Global
|
+44 203
749 5634
|
|
Rob
Skelding
|
UK/Global
|
+44 203
749 5821
|
|
Matt
Kent
|
UK/Global
|
+44 203
749 5906
|
|
Gonzalo
Viña
|
UK/Global
|
+44 203
749 5916
|
|
Jacob
Lund
|
Sweden
|
+46
8 553 260 20
|
|
Michele
Meixell
|
US
|
+1 302
885 2677
|
|
|
|
|
|
Investor
Relations
|
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203
749 5712
|
|
Josie
Afolabi
|
|
+44 203
749 5631
|
|
Craig
Marks
|
Finance;
Fixed Income; M&A
|
+44
7881 615 764
|
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
|
Mitchell
Chan
|
Oncology;
Other
|
+1 240
477 3771
|
|
Christer
Gruvris
|
Brilinta; Diabetes
|
+44 203
749 5711
|
|
Nick
Stone
|
Respiratory;
Renal
|
+44 203
749 5716
|
|
Jennifer
Kretzmann
|
Retail
Investors
|
+44 203
749 5824
|
|
US
toll-free
|
|
+1 866
381 7277
|
Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1
Alzheimer's Association. What is Alzheimer's? http://www.alz.org/alzheimers_disease_what_is_alzheimers.asp.
Accessed April 2018.
2
Alzheimer's Association. What is Dementia? http://www.alz.org/what-is-dementia.asp.
Accessed April 2018.
3 Alzheimer's Disease International. Dementia
Statistics. https://www.alz.co.uk/research/statistics.
Accessed April 2018.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
12 June
2018
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|