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 February 2023
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
AstraZeneca acquires CinCor for cardiorenal asset
24 February 2023 14:05 GMT
Acquisition of CinCor Pharma complete
AstraZeneca announced today the successful completion of the
acquisition of 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 bolsters AstraZeneca's cardiorenal pipeline by
adding baxdrostat (CIN-107), an aldosterone synthase inhibitor
(ASI) for blood pressure lowering in treatment-resistant
hypertension, to its cardiorenal portfolio.
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.
The acquisition was completed through a tender offer to purchase
all outstanding shares of CinCor for approximately
$1.3bn upfront. As part of the transaction, AstraZeneca
acquired the cash and marketable securities on CinCor's balance
sheet, which totalled approximately $500 million as of the closing,
excluding transaction-related expenses. Under the terms of the
agreement, CinCor shareholders also received a non-tradable
contingent value right, payable upon a specified regulatory
submission of a baxdrostat product. Combined, the upfront and
contingent value payments represent, if achieved, a transaction
value of approximately $1.8bn. As of the expiration of the
tender offer, 39,580,275 shares of CinCor were validly tendered and
not validly withdrawn from the tender offer, representing
approximately 86.3% of the outstanding shares of common stock of
CinCor, and such shares have been accepted for payment in
accordance with the terms of the tender offer. CinCor's shares will
be delisted from the Nasdaq Stock Market, and CinCor will terminate
its registration under the U.S. Securities Exchange Act of 1934 as
soon as practicable following completion of the
acquisition.
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 acquisition of CinCor. Such
forward-looking statements include, but are not limited to,
AstraZeneca's and CinCor's beliefs and expectations and statements
about the benefits sought to be achieved in AstraZeneca's
acquisition of CinCor, the potential effects of the acquisition on
both AstraZeneca and CinCor, 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 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, 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 2022, 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).
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.
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.
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:
24 February 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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