AstraZeneca announced it entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. The proposed deal will support the Alexion – which is AstraZeneca’s 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 for meeting major therapeutic goals for hypoparathyroidism.
Under the terms of the deal, AstraZeneca will acquire all of Amolyt Pharma’s outstanding shares for a total consideration of up to $1.05 billion, on a cash and debt-free basis. And this includes $800 million upfront at deal closing and the right for Amolyt Pharma’s shareholders to receive an additional contingent payment of $250 million payable upon achievement of a specified regulatory milestone. The deal is expected to close by the end of the third quarter of this year.
For patients with hypoparathyroidism, a deficiency in parathyroid hormone (PTH) production results in significant dysregulation of calcium and phosphate – which leads to life-altering symptoms and complications such as chronic kidney disease. This is one of the largest rare diseases, affecting over 200,000 people in the US and European Union, mostly women.
Eneboparatide is a PTH receptor 1 (PTHR1) agonist with a novel mechanism of action designed to meet the therapeutic goals of hypoparathyroidism. And Phase II data showed that eneboparatide achieved normalization of serum calcium levels and the potential to eliminate dependence on daily calcium and vitamin D supplementation. For adults with chronic hypoparathyroidism and hypercalciuria, the results showed that eneboparatide normalised calcium in urine. For patients with hypoparathyroidism, eneboparatide preserved bone mineral density, which is an important potential benefit in patients with an increased risk of osteopenia or osteoporosis.
KEY QUOTES:
“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.”
- Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease
“We enthusiastically welcome the proposed acquisition of Amolyt by AstraZeneca, an organisation that shares our dedication to delivering life-changing treatments to people living with rare diseases. This agreement offers the opportunity to meaningfully advance our pipeline therapies. Strong Phase II data suggest eneboparatide has the potential to improve outcomes for patients and to shift the treatment paradigm for hypoparathyroidism, and we look forward to seeing the continued advancement of the Phase III trial.”
- Thierry Abribat, Chief Executive Officer, Amolyt Pharma
