REG - AstraZeneca PLC - AstraZeneca acquires CinCor for cardiorenal asset

AstraZenecaAnnouncement

24/02/2023 14:15

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RNS Number : 0330R  AstraZeneca PLC  24 February 2023

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
humans(1). 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withdrawn from the tender offer, representing approximately 86.3% of the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 (http://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 doses(1).

 

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 period(1,2). 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 hypertension(3,4).
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 pancreas(7-9).
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 (https://www.astrazeneca.com/) and follow the
Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

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
(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
(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
(https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease)
[Last accessed 28 Dec 2022].

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

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