AstraZeneca Strengthens Rare Disease Portfolio with Amolyt Pharma Acquisition

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AstraZeneca announced on July 15, 2024 that it has completed its $1.05 billion acquisition of Amolyt Pharma, a clinical-stage biotechnology company focused on treatments for rare endocrine diseases. The acquisition adds eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide in development for treating hypoparathyroidism. The addition of this drug candidate boosts the AstraZeneca–Alexion Pharmaceuticals Rare Disease late-stage pipeline as well as the company’s bone metabolism franchise. AstraZeneca had acquired Alexion in 2021 (1,2).

Under the Amolyt Pharma acquisition, which AstraZeneca initially announced in March 2024 (3), AstraZeneca acquired all of Amolyt Pharma’s outstanding shares for a total consideration of up to $1.05 billion, which includes $800 million upfront at the closing of the deal plus the right for Amolyt Pharma’s shareholders to receive an additional $250 million contingent payment, based on a specified regulatory milestone.

Eneboparatide has a novel mechanism of action; it is designed to bind with high affinity to a specific conformation of the parathyroid hormone (PTH) receptor 1 (4). The therapeutic goals for this drug candidate include regulating and maintaining serum calcium levels in a normal range to manage symptoms of hypoparathyroidism; limiting the excretion of urine calcium by restoring the kidney’s ability to reabsorb calcium; and potentially preventing progressive kidney function decline and the onset of chronic kidney disease (5). Eneboparatide has also been designed to have a short plasma half-life to enable the restoration of bone turnover to a more physiologic state and to preserve bone integrity (4).

Hypoparathyroidism, a rare condition, is caused by a PTH deficiency, which leads to decreased calcium levels and elevated phosphorus levels in the blood (6). “Despite available treatments, patients experience persistent, life-altering symptoms and often develop complications and comorbidities that diminish quality of life and create segments of the patient population with specific clinical needs. Clinical manifestations of hypoparathyroidism impact many tissues and organ systems, in particular, the kidneys and bone,” AstraZeneca stated in a company press release.

The Amolyt Pharma acquisition is the latest in a series of billion-dollar-level acquisitions that AstraZeneca has completed so far this year. In February 2024, AstraZeneca completed its $1.1 billion acquisition of Icosavax, a clinical-stage biopharmaceutical company, and its $1.2 billion acquisition of Gracell Biotechnologies, a clinical-stage biopharmaceutical company specializing in cell therapies for cancer and autoimmune diseases (7,8). With the Icosavax acquisition, AstraZeneca gained IVX-A12, Icosavax’s lead investigational vaccine candidate that targets respiratory syncytial virus and human metapneumovirus. IVX-A12 is a combination protein virus-like particle platform vaccine that is Phase III-ready and has been granted fast track designation by FDA (7). Through the Gracell acquisition, AstraZeneca gained GC012F, a clinical-stage chimeric antigen receptor T-cell therapy. GC012F is, potentially, a new treatment for multiple myeloma and other hematologic malignancies and autoimmune diseases, including systemic lupus erythematosus (8).

References

1. AstraZeneca. AstraZeneca to Acquire Alexion, Accelerating the Company's Strategic and Financial Development. Press Release, Dec. 12, 2020.
2. AstraZeneca. Acquisition of Alexion Completed. Press Release, July 21, 2021.
3. AstraZeneca. AstraZeneca to acquire Amolyt Pharma, Expanding Late-Stage Rare Disease Pipeline. Press Release, March 14, 2024.
4. Takacs, I.; Mezosi, E.; Soto, A.; et al. An Open-Label Phase 2 Study of Eneboparatide, a Novel PTH Receptor 1 Agonist, in Hypoparathyroidism. J. Clin. Endocrinol. Metab. 2024, dgae121. DOI: 10.1210/clinem/dgae121
5. Khan, A.A.; Bilezikian, J. P.; Brandi, M.L.; et al. Evaluation and Management of Hypoparathyroidism Summary Statement and Guidelines from the Second International Workshop. J. Bone Miner. Res. 2022, 37 (12), 2568–2585. DOI: 10.1002/jbmr.4691
6. Clarke, B.L.; Brown, E.M.; Collins, M.T.; et al. Epidemiology and Diagnosis of Hypoparathyroidism. J. Clin. Endocrinol. Metab. 2016, 101 (6), 2284–2299. DOI: 10.1210/jc.2015-3908
7. AstraZeneca. Acquisition of Icosavax Completed. Press Release, Feb. 19, 2024.
8. AstraZeneca. Acquisition of Gracell Completed. Press Release, Feb. 22, 2024.

Source: AstraZeneca