AstraZeneca (AZ) has announced that it will be expanding its rare disease unit’s late-stage pipeline by acquiring Amolyt Pharma for more than $1bn.
The deal will build on Alexion’s bone metabolism franchise with the addition of eneboparatide (AZP-3601), a late-stage investigational therapeutic peptide being evaluated as a treatment for hypoparathyroidism.
Affecting an estimated 107,000 people in the EU, approximately 80% of whom are women, hypoparathyroidism is a rare condition defined by a deficiency of parathyroid hormone (PTH) that results in decreased calcium and elevated phosphorus levels in the blood.
Despite available treatments, AZ reports that patients experience persistent, life-altering symptoms and often develop complications and comorbidities that affect their quality of life.
Eneboparatide is a PTH receptor 1 agonist with “a novel mechanism of action rationally designed to meet the therapeutic goals of hypoparathyroidism,” the company said.
Marc Dunoyer, chief executive officer of Alexion, AZ Rare Disease, said: “Chronic hypoparathyroid patients face a significant need for an alternative to current supportive therapies, which do not address the underlying hormone deficiency.”
“We believe this programme, together with Amolyt’s talented team, expertise and earlier pipeline, will enable our expansion into rare endocrinology,” Dunoyer added.
Mid-stage data for the candidate showed that it achieved normalisation of serum calcium levels and demonstrated the potential to eliminate dependence on daily calcium and vitamin D supplementation.
Results also showed that eneboparatide normalised calcium in urine in adults with chronic hypoparathyroidism and hypercalciuria, and for patients with hypoparathyroidism, the therapy preserved bone mineral density.
Under the terms of the agreement, which is expected to close in the third quarter of this year, AZ will acquire all of Amolyt’s outstanding shares for a total consideration of up to $1.05bn.
This includes $800m upfront plus the right for Amolyt shareholders to receive an additional contingent payment of $250m payable upon achievement of a specified regulatory milestone.
Also commenting on the intended acquisition, Amolyt’s chief executive officer, Thierry Abribat, said: “This agreement offers the opportunity to meaningfully advance our pipeline therapies.
“Strong phase 2 data suggests 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 3 trial.”