AZP-40XX

Pictured: AstraZeneca's headquarters in Silicon Valley/iStock, Sundry Photography AstraZeneca on Thursday announced that it is acquiring rare disease specialist Amolyt Pharma in a deal that could reach $1.05 billion in value. Under the terms of the agreement, AstraZeneca will buy Amolyt’s outstanding shares for a total of $800 million, due on the deal’s closing. Amolyt will also be entitled to a contingent payment of $250 million upon meeting a yet-undisclosed regulatory milestone. The partners expect to complete the transaction in the third quarter of 2024, pending regulatory clearances and other customary closing conditions. After the acquisition is closed, Amolyt and its employees will join AstraZeneca’s rare disease unit Alexion. At the center of the acquisition is Amolyt’s late-stage candidate for the rare disease hypoparathyroidism, which is characterized by low levels of the parathyroid hormones in the blood. Patients with hypoparathyroidism also have abnormal levels of calcium and phosphorous, which can lead to complications such as kidney problems and heart failure. “Chronic hypoparathyroid patients face a significant need for an alternative to current supportive therapies, which do not address the underlying hormone deficiency,” Alexion CEO Marc Dunoyer said in a statement, adding that eneboparatide could “lessen the often-debilitating impact of low parathyroid hormone” while also avoiding the “risks of high-dose calcium supplementation.” Dubbed eneboparatide, Amolyt’s candidate for hypoparathyroidism activates the parathyroid hormone receptor 1, leading to stable and sustained calcium levels in the blood and normal calcium excretion through the urine. According to the biotech’s website, this mechanism of action allows eneboparatide to treat the symptoms of hypoparathyroidism and avoid kidney disease, while also slowly removing the need for calcium and vitamin D supplementation. Eneboparatide also helps preserve bone integrity by normalizing bone turnover levels and lowering bone resorption. In a Phase IIa study, 93% of patients who were treated with eneboparatide were able to stop standard of care treatment using calcium and vitamin D supplementation. Urinary calcium excretion also dropped to normal levels, while serum calcium levels remained within target range. Patients also showed stable bone mineral density, including those who had osteopenia. In May 2023, Amolyt announced that it had competed an end-of-Phase II meeting with the FDA and that it would launch a Phase III study of eneboparatide in hypoparathyroidism. The biotech at the time envisioned the study, dubbed Calypso, to be the largest Phase III trial to date in this indication. Top-line data are expected by the end of 2024. In addition to eneboparatide, AstraZeneca will also gain ownership of AZP-3813, which is being assessed for acromegaly with topline Phase I data expected in the first half of this year. Amolyt is also developing AZP-40XX, which is still in the very early stages of development for primary hyperparathyroidism and humoral hypercalcemia of malignancy. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.