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 considerationsUnder 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.
About 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.
About FarxigaFarxiga (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).
About Transaction detailsThe 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.
About AstraZeneca in CVRMCardiovascular, 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.
About AstraZenecaAstraZeneca (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.
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].
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