AstraZeneca is bolstering its uncommon illness pipeline with a deal to purchase Amolyt Pharma, a biotech firm in late-stage growth with a remedy designed to deal with a uncommon hormone deficiency whose solely FDA-approved remedy will quickly stop manufacturing.
In response to deal phrases introduced Thursday, AstraZeneca is paying Amolyt shareholders $800 million up entrance. One other $250 million is tied to the achievement of a regulatory milestone that was not disclosed. Contemplating that the drug is in Section 3 testing, that milestone could possibly be a regulatory approval.
Lyon, France-based Amolyt is growing a remedy for hypoparathyroidism, a illness through which the parathyroid glands don’t produce sufficient parathyroid hormone. This hormone is vital for regulating calcium and phosphate ranges within the blood. Illness signs embrace tingling or burning sensations within the fingertips and toes, muscle aches or cramps, muscle twitching or spasms, and fatigue.
Hypoparathyroidism disproportionately impacts ladies. Calcium and vitamin D dietary supplements will help, however at excessive doses, calcium dietary supplements can result in gastrointestinal issues comparable to constipation. When dietary supplements alone aren’t sufficient to handle hypoparathyroidism, the one FDA-approved remedy is Natpara, an engineered model of parathyroid hormone offered by Takeda Pharmaceutical.
Amolyt may convey sufferers a special option to handle hypoparathyroidism. The biotech’s drug candidate, eneboparatide, is a peptide designed to bind to PTH receptor 1, the receptor that native parathyroid hormone binds to. In Section 2 outcomes reported in 2022, Amolyt stated its drug led to regular calcium ranges within the blood as nicely the potential to remove the necessity for day by day calcium and vitamin D dietary supplements. Moreover, the drug preserved bone mineral density, which is vital for sufferers at greater danger of growing bone issues comparable to osteopenia or osteoporosis. Amolyt has stated it expects preliminary Section 3 information will develop into accessible by the tip of 2024.
The market want for brand spanking new hypoparathyroidism therapies is turning into pressing. Takeda’s Natpara (Natpar exterior of the U.S.) has had a rocky commercialization historical past since its FDA approval in 2015. In 2019, the FDA issued a recall attributable to potential contamination from tiny rubber particles from the cartridge housing the injectable product. Takeda’s efforts to resolve the issue to the FDA’s satisfaction have been unsuccessful. In late 2022, Takeda stated it deliberate to discontinue manufacturing of Natpara/Natpar by the tip of 2024. After that, the corporate stated it will provide the remaining doses of the drug till stock is depleted or the product is expired.
The Amolyt acquisition brings AstraZeneca into a gaggle of firms vying to fill the hypoparathyroidism remedy want that shall be left when Takeda’s drug is not accessible. An FDA resolution is anticipated in Could for Ascendis Pharma’s peptide drug Transcon PTH. Prolong Biosciences is in Section 1 testing with a drug derived from parathyroid hormone. MBX Biosciences has reached Section 2 testing with a peptide drug. These drug candidates are injectable. Septerna is growing an oral drug for hypoparathyroidism. Final yr, the South San Francisco-based startup raised $150 million in financing to advance the small molecule to Section 1 testing.
Amolyt final raised cash in early 2023, a €130 million (about $138 million) Sequence C financing to assist its pipeline. In addition to the hypoparathyroidism program, that pipeline consists of AZP-3813, a possible remedy for acromegaly, a illness through which the physique produces an excessive amount of progress hormone. Section 1 testing started final summer time. Amolyt has stated it expects preliminary information within the first half of 2024.
AstraZeneca expects to finish the Amolyt acquisition by the tip of the third quarter of this yr. When the deal closes, Amolyt will develop into a part of Alexion, AstraZeneca Uncommon Illness, the pharmaceutical big’s Boston-based uncommon illness division. AstraZeneca stated the acquisition will allow it to increase its uncommon illness analysis into endocrinology.
“Power hypoparathyroid sufferers face a big want for a substitute for present supportive therapies, which don’t deal with the underlying hormone deficiency,” Marc Dunoyer, CEO of Alexion, AstraZeneca Uncommon Illness, stated in a ready assertion. “As leaders in uncommon illness, Alexion is uniquely positioned to drive the late-stage growth and international commercialization of eneboparatide, which has the potential to minimize the customarily debilitating impression of low parathyroid hormone and keep away from the dangers of high-dose calcium supplementation.”
Photograph: Christopher Furlong, Getty Pictures
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