REG - AstraZeneca PLC - AstraZeneca acquire CinCor for cardiorenal asset

AstraZenecaAnnouncement

09/01/2023 07:00

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RNS Number : 0139M  AstraZeneca PLC  09 January 2023

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
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.

 

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 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.

 

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 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).

 

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
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=52501144&newsitemid=20210930005314&lan=en-US&anchor=www.sec.gov&index=10&md5=58708aa2fee2f79c4c4237ffac511584)
 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
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=52501144&newsitemid=20210930005314&lan=en-US&anchor=www.sec.gov&index=11&md5=e3a53cdaaaaaff7b5b09861e45017207)
. 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. (http://www.astrazeneca.com) astrazeneca (http://www.astrazeneca.com)
.com (http://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. (http://www.cincor.com) cincor
(http://www.cincor.com) .com (http://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 (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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