AstraZeneca is paying $800 million to expand into rare endocrinology, snagging itself a phase 3 candidate through the acquisition of French biotech Amolyt Pharma. The deal features $250 million in milestones tied to a regulatory event.
Buying Amolyt will give AstraZeneca control of eneboparatide, a PTHR1 agonist that the biotech moved into phase 3 in June. Eneboparatide is designed to produce sustained and stable levels of calcium, which falls to low levels in patients with hypoparathyroidism, while preventing kidney disease and restoring bone turnover.
People with the thyroid disease take supplements to restore blood calcium levels, often for life. Amolyt’s phase 3 study is assessing whether eneboparatide can free patients from the need to take vitamin D and oral calcium. If the molecule can give patients that freedom and keep serum calcium in the normal range, the study could meet its primary endpoint and position AstraZeneca to file for approval.
Marc Dunoyer, CEO of AstraZeneca’s rare disease unit Alexion, said in a statement that eneboparatide has the “potential to lessen the often debilitating impact of low parathyroid hormone and avoid the risks of high-dose calcium supplementation.” AstraZeneca’s move to address that need is part of a push into a new therapeutic area.
“Chronic hypoparathyroid patients face a significant need for an alternative to current supportive therapies, which do not address the underlying hormone deficiency,” Dunoyer said. “We believe this program, together with Amolyt’s talented team, expertise and earlier pipeline, will enable our expansion into rare endocrinology.”
The FDA approved NPS Pharmaceuticals’ Natpara, which is now sold by Takeda, in hypoparathyroidism in 2015, but manufacturing problems have blighted the product. Takeda recalled batches from the U.S. in 2019 and, after the timeline for returning to the market slipped, decided to give up altogether in 2022. The drugmaker plans to stop manufacturing the drug globally by the end of the year.