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 January 2023
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form
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permitted by Regulation S-T Rule 101(b)(1):
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permitted by Regulation S-T Rule 101(b)(7): ______
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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.
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“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.
AstraZeneca acquire CinCor for cardiorenal asset
9
January 2023 07:00 GMT
AstraZeneca
to acquire CinCor Pharma to strengthen cardiorenal
pipeline
Acquisition to access global rights to baxdrostat,
a novel aldosterone synthase inhibitor in development for blood
pressure lowering
AstraZeneca has
entered into a definitive agreement to acquire CinCor Pharma, Inc.
(CinCor), a US-based clinical-stage biopharmaceutical company,
focused on developing novel treatments for resistant and
uncontrolled hypertension as well as chronic kidney
disease.
The
acquisition will bolster AstraZeneca's cardiorenal pipeline by
adding CinCor's candidate drug, baxdrostat (CIN-107), an
aldosterone synthase inhibitor (ASI) for blood pressure lowering in
treatment-resistant hypertension.
Baxdrostat
represents a potentially leading next-generation ASI as it is
highly selective for aldosterone synthase and spares the cortisol
pathway in humans1. The opportunity
also brings the potential for combination with Farxiga and complements
AstraZeneca's strategy to provide added benefit across cardiorenal
diseases, where there is a high unmet medical need.
Mene
Pangalos, Executive Vice President BioPharmaceuticals R&D,
AstraZeneca, said: "Acquiring CinCor supports our commitment to
cardiorenal disease and further strengthens our pipeline with
baxdrostat. Excess levels of aldosterone are associated with
hypertension and several cardiorenal diseases, including chronic
kidney disease and coronary artery disease and being able to
effectively reduce this would offer a much-needed treatment option
for these patients."
Marc de
Garidel, CEO CinCor, said: "We are excited about the proposed
acquisition of CinCor Pharma by AstraZeneca as we believe it offers
the prospect of accelerating the development timeline and expanding
the breadth of benefits patients with cardiorenal diseases might
obtain from baxdrostat, if approved. CinCor is committed to
ensuring a smooth transition of the development responsibilities to
AstraZeneca once the acquisition is consummated. Thank you to all
who have played, and will continue to play, essential roles in
developing and evaluating baxdrostat as a potential novel treatment
for cardiorenal diseases."
Financial
considerations
Under
the terms of the agreement, AstraZeneca will initiate a tender
offer to acquire all of CinCor's outstanding shares for a price of
$26 per share in cash at closing, plus a non-tradable contingent
value right of $10 per share in cash payable upon a specified
regulatory submission of a baxdrostat product. The upfront cash
portion of the consideration represents a transaction value of
approximately $1.3bn and a 121% premium over CinCor's closing
market price on 06 January 2023. Combined, the upfront and maximum
potential contingent value payments represent, if achieved, a
transaction value of approximately $1.8bn and a 206% premium over
CinCor's closing market price on 6 January 2023. As part of the
transaction, AstraZeneca will acquire the cash and marketable
securities on CinCor's balance sheet, which totalled approximately
$522m as of 30 September 2022.
Notes
Baxdrostat (CIN-107)
Baxdrostat is a
highly selective, oral small molecule inhibitor of aldosterone
synthase, the enzyme responsible for the synthesis of aldosterone
in the adrenal gland, in development for patient populations with
significant unmet medical needs, including treatment-resistant
hypertension, primary aldosteronism and chronic kidney disease.
Baxdrostat selectively targets aldosterone synthase, which is
encoded by the CYP11B2 gene while having a much lower affinity for
the blocking activity of 11ß-hydroxylase, the enzyme responsible
for cortisol synthesis, which is encoded by the CYP11B1 gene. In
clinical trials, baxdrostat was observed to significantly lower
aldosterone levels without affecting cortisol levels, across a wide
range of doses1.
In
patients with treatment-resistant hypertension, a key focus area,
baxdrostat met the primary endpoint in the BrigHTN Phase II trial
showing a statistically significant reduction in systolic blood
pressure (SBP) after a 12-week treatment period1,2. Baxdrostat did
not meet the primary endpoint of showing a statistically
significant reduction in SBP at eight weeks in the HALO Phase II
trial in patients with uncontrolled hypertension3,4. Baxdrostat was
well tolerated in both trials. Two additional Phase II trials are
ongoing in hypertensive patients with primary aldosteronism
(Spark-PA)5 and in chronic
kidney disease (CKD)6. A Phase III trial
of baxdrostat is planned to start in treatment-resistant
hypertension during the first half of 2023.
CinCor
holds the exclusive, worldwide licence to baxdrostat, which will
remain in place following the transaction.
Farxiga
Farxiga (dapagliflozin) is a
first-in-class, oral, once-daily SGLT2 inhibitor. Research has
shown Farxiga's efficacy in preventing
and delaying cardiorenal disease, while also protecting the organs
- important findings given the underlying links between the heart,
kidneys and pancreas7-9. Damage to one of
these organs can cause the other organs to fail, contributing to
leading causes of death worldwide, including T2D, HF and chronic
kidney disease (CKD)10-13.
Transaction
details
The
closing of the tender offer will be subject to certain conditions,
including the tender of shares representing at least a majority of
the total number of CinCor's outstanding shares, and other
customary regulatory clearances. Upon the successful completion of
the tender offer, AstraZeneca's acquisition subsidiary will be
merged with and into CinCor, and any remaining shares of common
stock of CinCor will be cancelled and converted into the right to
receive the same merger consideration (including the contingent
value right) per share payable in the tender offer. Subject to the
satisfaction of the conditions in the merger agreement, the
acquisition is expected to close in the first quarter of
2023.
Important
information about the tender offer
The
tender offer described in this announcement has not yet commenced.
This announcement is for informational purposes only and is neither
an offer to purchase nor a solicitation of an offer to sell any
shares of the common stock of CinCor or any other securities, nor
is it a substitute for the tender offer materials described herein.
At the time the planned tender offer is commenced, a tender offer
statement on Schedule TO, including an offer to purchase, a letter
of transmittal and related documents, will be filed by AstraZeneca
PLC (AstraZeneca), AstraZeneca Finance and Holdings Inc. and
Cinnamon Acquisition, Inc., a wholly-owned indirect subsidiary of
AstraZeneca, with the Securities and Exchange Commission (the SEC),
and a solicitation/recommendation statement on Schedule 14D-9 will
be filed by CinCor with the SEC.
INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ BOTH THE
TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED
LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND
THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9
REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN
THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER
BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR
SECURITIES.
Investors and security holders may obtain a free
copy of the Offer to Purchase, the related Letter of Transmittal,
certain other tender offer documents and the
Solicitation/Recommendation Statement (when available) and other
documents filed with the SEC at the website maintained by the SEC
at www.sec.gov or
by directing such requests to the information agent for the tender
offer, which will be named in the tender offer statement. In
addition, CinCor files annual, quarterly and current reports and
other information, and AstraZeneca files annual reports and other
information with the SEC, which are available to the public from
commercial document-retrieval services and at the SEC's website
at www.sec.gov.
Copies of the documents filed with the SEC by AstraZeneca may be
obtained at no charge on the investor relations page of
AstraZeneca's internet website at www.astrazeneca.com/investors.
Copies of the documents filed with the SEC by CinCor may be
obtained at no charge under the "Investors" section of CinCor's
internet website at www.cincor.com.
Forward-looking
statements
This
announcement may include statements that are not statements of
historical fact, or "forward-looking statements," including with
respect to AstraZeneca's proposed acquisition of CinCor. Such
forward-looking statements include, but are not limited to, the
ability of AstraZeneca and CinCor to complete the transactions
contemplated by the acquisition agreement, including the parties'
ability to satisfy the conditions to the consummation of the offer
contemplated thereby and the other conditions set forth in the
merger agreement, statements about the expected timetable for
completing the transaction, AstraZeneca's and CinCor's beliefs and
expectations and statements about the benefits sought to be
achieved in AstraZeneca's proposed acquisition of CinCor, the
potential effects of the acquisition on both AstraZeneca and
CinCor, the possibility of any termination of the acquisition
agreement, as well as the expected benefits and success of
baxdrostat and any combination product. These statements are based
upon the current beliefs and expectations of AstraZeneca's and
CinCor's management and are subject to significant risks and
uncertainties. There can be no guarantees that the conditions to
the closing of the proposed transaction will be satisfied on the
expected timetable or at all or that baxdrostat or any combination
product will receive the necessary regulatory approvals or prove to
be commercially successful if approved. If underlying assumptions
prove inaccurate or risks or uncertainties materialise, actual
results may differ materially from those set forth in the
forward-looking statements.
Risks
and uncertainties include but are not limited to, uncertainties as
to the timing of the offer and the subsequent merger; uncertainties
as to how many of CinCor's stockholders will tender their shares in
the offer; the risk that competing offers or acquisition proposals
will be made; the possibility that various conditions to the
consummation of the offer and the merger contemplated by the
acquisition agreement may not be satisfied or waived; the ability
to obtain necessary regulatory approvals or to obtain them on
acceptable terms or within expected timing; the effects of
disruption from the transactions contemplated by the acquisition
agreement and the impact of the announcement and pendency of the
transactions on CinCor's business; the risk that stockholder
litigation in connection with the offer or the merger may result in
significant costs of defense, indemnification and liability; the
possibility that the milestone related to the contingent value
right will not be achieved; general industry conditions and
competition; general economic factors, including interest rate and
currency exchange rate fluctuations; the impact of COVID-19; the
impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; competition
from other products; and challenges inherent in new product
development, including obtaining regulatory approval.
Neither
AstraZeneca nor CinCor undertakes any obligation to publicly update
any forward-looking statement, whether as a result of new
information, future events or otherwise, except to the extent
required by law. Additional factors that could cause results to
differ materially from those described in the forward-looking
statements can be found in AstraZeneca's Annual Report on Form 20-F
for the year ended 31 December 2021, CinCor's Annual Report on Form
10-K for the year ended 31 December 2021 and CinCor's Quarterly
Reports on Form 10-Q for the three months ended 31 March 2022, 30
June 2022 and 30 September 2022, in each case as amended by any
subsequent filings made with the SEC. These and other filings made
by AstraZeneca and CinCor with the SEC are available at the SEC's
Internet site (www.sec.gov).
AstraZeneca
in CVRM
Cardiovascular,
Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one
of AstraZeneca's main disease areas and is a key growth driver for
the Company. By following the science to understand more clearly
the underlying links between the heart, kidneys and pancreas,
AstraZeneca is investing in a portfolio of medicines for organ
protection and improve outcomes by slowing disease progression,
reducing risks and tackling co-morbidities. The Company's ambition
is to modify or halt the natural course of CVRM diseases and
potentially regenerate organs and restore function, by continuing
to deliver transformative science that improves treatment practices
and CV health for millions of patients worldwide.
AstraZeneca
AstraZeneca
(LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and
commercialisation of prescription medicines in Oncology, Rare
Diseases, and BioPharmaceuticals, including Cardiovascular, Renal
& Metabolism, and Respiratory & Immunology. Based in
Cambridge, UK, AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For
details on how to contact the Investor Relations Team, please
click here. For Media
contacts, click here.
References
1.
Freeman MW, et al. (2022) Phase 2 Trial of Baxdrostat for
Treatment-Resistant Hypertension. NEJM, DOI:
10.1056/NEJMoa2213169.
2. A
Study of CIN-107 in Adults With Treatment-Resistant Hypertension
(rHTN) (BrigHTN). Available from:
https://www.clinicaltrials.gov/ct2/show/NCT04519658?term=cin-107&draw=2&rank=2
[Last accessed 28 Dec 2022]
3.
CinCor Pharma Announces Topline Data for Phase 2 HALO Trial
Evaluating Selective Aldosterone Synthase Inhibitor Baxdrostat in
Uncontrolled Hypertension. Available from:
https://www.cincor.com/news-releases/news-release-details/cincor-pharma-announces-topline-data-phase-2-halo-trial
[Last accessed 30 Dec 2022].
4. A
Study of CIN-107 in Patients With Uncontrolled Hypertension
Receiving 1 Antihypertensive Agent (HALO). Available from:
https://www.clinicaltrials.gov/ct2/show/NCT05137002?term=cin-107&draw=2&rank=1
[Last accessed 28 Dec 2022]
5. A
Study of CIN-107 in Adults With Primary Aldosteronism (spark-PA).
Available from:
https://www.clinicaltrials.gov/ct2/show/NCT04605549?term=cin-107&draw=2&rank=3
[Last accessed 28 Dec 2021]
6. A Study to Evaluate CIN-107 for the
Treatment of Patients With Uncontrolled
Hypertension and Chronic Kidney Disease. Available
from: https://clinicaltrials.gov/ct2/show/NCT05432167?term=CIN-107&draw=2&rank=4 [Last
accessed 28 Dec 2022].
7.
McMurray JJV, et al. (2019) Dapagliflozin in patients with heart
failure and reduced ejection fraction. NEJM, 381(21):1995-2008.
8.
Heerspink HJL, et al. (2020) Dapagliflozin in patients with chronic
kidney disease. NEJM,
383(15):1436-46.
9.
Wiviott SD, et al. (2019) Dapagliflozin and cardiovascular outcomes
in type-2 diabetes [article and supplementary
appendix]. NEJM,
380(4):347-57.
10. Mayo
Clinic [Internet]. Heart failure [cited 2022 Nov 23]. Available
from:
https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.
11. Vos T, et
al. (2017) Global, regional, and national incidence, prevalence,
and years lived with disability for 328 diseases and injuries for
195 countries, 1990-2016: A systematic analysis for the Global
Burden of Disease Study 2016. Lancet, 390(10100):1211-59.
12. Centers for Disease Control and
Prevention (CDC) [Internet]. A snapshot: Diabetes in the United
States. Available from: https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html [Last
accessed 28 Dec 2022].
13. National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK) [Internet]. Heart disease
& kidney disease. Available from: https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease [Last
accessed 28 Dec 2022].
Adrian
Kemp
Company
Secretary
AstraZeneca
PLC
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:
09 January 2023
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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