15 July 2024
Acquisition of Amolyt Pharma
completed
AstraZeneca today announced the successful
completion of the
acquisition of Amolyt Pharma, a
clinical-stage biotechnology company focused on developing novel
treatments for rare endocrine diseases.
The acquisition bolsters the Alexion,
AstraZeneca Rare Disease late-stage pipeline and expands 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. 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.1
This programme, together with Amolyt's talent,
expertise and earlier pipeline, will enable Alexion's expansion
into rare endocrinology.
Financial
considerations
Under the terms of the definitive agreement,
AstraZeneca has acquired all of Amolyt Pharma's outstanding shares
for a total consideration of up to $1.05 billion, on a cash and
debt free basis. This includes $800 million upfront at deal
closing, plus the right for Amolyt Pharma's shareholders to receive
an additional contingent payment of $250 million payable upon
achievement of a specified regulatory milestone. AstraZeneca looks
forward to welcoming the employees of Amolyt Pharma.
Notes
Eneboparatide (AZP-3601)
Eneboparatide (AZP-3601) is an
investigational therapeutic peptide designed to bind with high
affinity to a specific conformation of the parathyroid hormone
(PTH) receptor 1.2 Therapeutic goals include: regulating
and maintaining serum calcium levels in the normal range, and
thereby managing the symptoms of hypoparathyroidism; limiting urine
calcium excretion by restoring calcium reabsorption by the kidney;
and potentially preventing progressive decline in kidney function
and the development of chronic kidney disease.3
Eneboparatide is also designed to have a short plasma half-life to
potentially restore bone turnover to a more physiologic state and
to help preserve bone integrity.2
Hypoparathyroidism
Hypoparathyroidism is a rare
condition defined by a deficiency of parathyroid hormone that
results in decreased calcium and elevated phosphorus levels in the
blood.1 Approximately 80% of the estimated 115,000
people in the United States and 107,000 in the European Union with
hypoparathyroidism are women.4,5 Despite available
treatments, patients experience persistent, life-altering symptoms
and often develop complications and comorbidities that diminish
quality of life and create segments of the patient population with
specific clinical needs. Clinical manifestations of
hypoparathyroidism impact many tissues and organ systems, in
particular, the kidneys and bone.6,7
Forward-looking
statements
This announcement may include statements that
are not statements of historical fact, or "forward-looking
statements," including with respect to AstraZeneca's acquisition of
Amolyt Pharma. Such forward-looking statements include, but are not
limited to, AstraZeneca's and Amolyt Pharma's beliefs and
expectations and statements about the benefits sought to be
achieved in AstraZeneca's acquisition of Amolyt Pharma, the
potential effects of the acquisition on both AstraZeneca and Amolyt
Pharma, as well as the expected benefits and success of
eneboparatide (AZP-3601). These statements are based upon the
current beliefs and expectations of AstraZeneca's and Amolyt
Pharma's management and are subject to significant risks and
uncertainties. There can be no guarantees that eneboparatide
(AZP-3601) will receive the necessary regulatory approvals or prove
to be commercially successful if approved. If underlying
assumptions prove inaccurate or risks or uncertainties materialise,
actual results may differ materially from those set forth in the
forward-looking statements. Risks and uncertainties include, but
are not limited to, uncertainties as to the ability to obtain
necessary regulatory approvals or to obtain them on acceptable
terms or within expected timing; the risk that shareholder
litigation in connection with the offer or the acquisition may
result in significant costs of defence, indemnification and
liability; the possibility that the achievement of the specified
milestone described in the acquisition agreement may take longer to
achieve than expected or may never be achieved and the resulting
contingent milestone payment may never be realised; general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of COVID-19; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; competition from other products; and challenges
inherent in new product development, including obtaining regulatory
approval.
Neither AstraZeneca nor Amolyt Pharma
undertakes any obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise, except to the extent required by law. Additional factors
that could cause results to differ materially from those described
in the forward-looking statements can be found in AstraZeneca's
Annual Report on Form 20-F for the year ended 31 December 2023, as
amended by any subsequent filings made with the SEC. These and
other filings made by AstraZeneca with the SEC are available
at www.sec.gov.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global,
science-led biopharmaceutical company that focuses on the
discovery, development, and commercialisation of prescription
medicines in Oncology, Rare Diseases, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca's innovative
medicines are sold in more than 125 countries and used by millions
of patients worldwide. Please visit astrazeneca.com and follow
the Company on social media @AstraZeneca
Contacts
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References
1.
Clarke BL, et al. Epidemiology and diagnosis of
hypoparathyroidism. J Clin
Endocrinol Metab. 2016;101(6):2284-99.
2.
Takacs I, et al. An open-label phase 2
study of eneboparatide, a novel PTH receptor 1 agonist, in
hypoparathyroidism. J Endocrinol Metab.
2024;dgae121.
3.
Khan A, et al. Evaluation and management of
hypoparathyroidism summary statement and guidelines from the second
international workshop. J Bone
Miner Res. 2022;37(12):2568-2585.
4. Vadiveloo, T, et al. A Population-based study of the
Epidemiology of Chronic Hypoparathyroidism. J Bone Miner Res.
2018;33(3):478-485.
5. Villarroya-Marquina I,
et al. Influence of gender and women's age
on the prevalence of parathyroid failure after total thyroidectomy
for multinodular goiter. Gland Surg.
2020;9(2):245-251.
6. Bilezikian JP.
Hypoparathyroidism. J Clin
Endocrinol Metab. 2020;105(6):1722-36.
7. Abate EG, et al. Review of
Hypoparathyroidism. Front
Endocrinol (Lausanne). 2017;7:172.
Adrian Kemp
Company Secretary
AstraZeneca PLC