TIDMAZN
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withdrawn from the tender offer, representing approximately 86.3%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 ).
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 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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCFLFSVFTISFIV
(END) Dow Jones Newswires
February 24, 2023 09:05 ET (14:05 GMT)
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Sep 2023 to Sep 2024