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AstraZeneca to acquire Amolyt Pharma

Marc Dunoyer

AstraZeneca has entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases.

Under the terms of the agreement, AstraZeneca will acquire all of Amolyt Pharma’s outstanding shares for a total consideration of up to USD 1.05 billion, on a cash and debt free basis. This includes USD 800 million upfront at deal closing, plus the right for Amolyt Pharma’s shareholders to receive an additional contingent payment of USD 250 million payable upon achievement of a specified regulatory milestone.

The proposed acquisition will bolster the Alexion, AstraZeneca Rare Disease late-stage pipeline and expand on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of action designed to meet key therapeutic goals for hypoparathyroidism, it states. Additionally, Alexion is looking forward to welcoming talent from Amolyt Pharma.

Hypoparathyroidism

In patients with hypoparathyroidism, a deficiency in parathyroid hormone (PTH) production results in significant dysregulation of calcium and phosphate, which can lead to life-altering symptoms and complications, including chronic kidney disease. It is one of the largest known rare diseases, affecting an estimated 115,000 people in the United States and 107,000 people in the European Union, approximately 80% of whom are women.

“Chronic hypoparathyroid patients face a significant need for an alternative to current supportive therapies, which do not address the underlying hormone deficiency. As leaders in rare disease, Alexion is uniquely positioned to drive the late-stage development and global commercialisation of eneboparatide, which has the potential to lessen the often debilitating impact of low parathyroid hormone and avoid the risks of high-dose calcium supplementation. We believe this programme, together with Amolyt’s talented team, expertise and earlier pipeline, will enable our expansion into rare endocrinology,” says Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease.

Eneboparatide

Eneboparatide is a PTH receptor 1 (PTHR1) agonist with a novel mechanism of action rationally designed to meet the therapeutic goals of hypoparathyroidism. Phase II data showed that eneboparatide achieved normalisation of serum calcium levels as well as the potential to eliminate dependence on daily calcium and vitamin D supplementation. In adults with chronic hypoparathyroidism and hypercalciuria, results showed that eneboparatide normalised calcium in urine. In addition, for patients with hypoparathyroidism, eneboparatide preserved bone mineral density, an important potential benefit in patients with an increased risk of osteopenia or osteoporosis.

Photo of Marc Dunoyer: Alexion

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