REG - AstraZeneca PLC - AstraZeneca to acquire Amolyt

AstraZenecaAnnouncement

14/03/2024 07:00

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RNS Number : 8414G  AstraZeneca PLC  14 March 2024

14 March, 2024

 

AstraZeneca to acquire Amolyt Pharma,

expanding late-stage rare disease pipeline

 

Amolyt development portfolio includes Phase III asset with potential to
address significant unmet need in patients with chronic hypoparathyroidism

 

Acquisition to further expand the Alexion, AstraZeneca Rare Disease pipeline
beyond complement inhibition, building on company's success in bone metabolism
and opportunity in rare endocrinology

AstraZeneca announced that it has 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 acquisition will bolster the Alexion, AstraZeneca 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 to meet key
therapeutic goals for hypoparathyroidism. Additionally, Alexion is looking
forward to welcoming talent from Amolyt Pharma.

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) It is one of the largest known rare diseases, affecting an
estimated 115,000 people in the United States and 107,000 people in the
European Union, approximately 80% of whom are women.(2,3)

 

Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca 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. 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."

 

Thierry Abribat, Chief Executive Officer, Amolyt Pharma, said: "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."

 

Eneboparatide is a PTH receptor 1 (PTHR1) agonist with a novel mechanism of
action rationally designed to meet the therapeutic goals of
hypoparathyroidism.(4) Phase II data showed that eneboparatide achieved
normalisation of serum calcium levels as well as the potential to eliminate
dependence on daily calcium and vitamin D supplementation. In adults with
chronic hypoparathyroidism and hypercalciuria, results showed that
eneboparatide normalised calcium in urine. In addition, for patients with
hypoparathyroidism, eneboparatide preserved bone mineral density, an important
potential benefit in patients with an increased risk of osteopenia or
osteoporosis.(5)

 

Financial considerations

Under the terms of the agreement, 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. 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.

 

Subject to the satisfaction of customary closing conditions in the acquisition
agreement, including regulatory clearances, the transaction is expected to
close by the end of the third quarter of 2024.

 

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. 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. 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.

 

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.(2,3) 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
proposed acquisition of Amolyt Pharma. Such forward-looking statements
include, but are not limited to, the ability of AstraZeneca and Amolyt Pharma
to complete the transactions contemplated by the acquisition agreement,
including the parties' ability to satisfy the conditions set forth in the
acquisition agreement, statements about the expected timetable for completing
the transaction, AstraZeneca's and Amolyt Pharma's beliefs and expectations
and statements about the benefits sought to be achieved in AstraZeneca's
proposed acquisition of Amolyt Pharma, the potential effects of the
acquisition on both AstraZeneca and Amolyt Pharma, the possibility of any
termination of the acquisition agreement, 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 the conditions to the closing of the proposed
transaction will be satisfied on the expected timetable or at all or 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 timing of the acquisition;  the possibility that various conditions to
the consummation of the acquisition contemplated by the acquisition agreement
may not be satisfied or waived; the ability to obtain necessary regulatory
approvals or to obtain them on acceptable terms or within expected timing; the
effects of disruption from the transactions contemplated by the acquisition
agreement and the impact of the announcement and pendency of the transactions
on Amolyt Pharma's business; 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
(https://azcollaboration.sharepoint.com/sites/ProjectAntibes-Transaction/Shared%20Documents/General/7.%20Communications/www.sec.gov)
.

Alexion

Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on
rare diseases, created following the 2021 acquisition of Alexion
Pharmaceuticals, Inc. As a leader in rare diseases for more than 30 years,
Alexion is focused on serving patients and families affected by rare diseases
and devastating conditions through the discovery, development and
commercialisation of life-changing medicines. Alexion focuses research efforts
on novel molecules and targets that include the complement cascade, and
development efforts in haematology, nephrology, neurology, metabolic
disorders, cardiology and ophthalmology. Headquartered in Boston,
Massachusetts, Alexion has offices around the globe and serves patients in
more than 70 countries.

 

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 operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the
Company on social media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   Clarke BL, et al. Epidemiology and diagnosis of hypoparathyroidism. J
Clin Endocrinol Metab. 2016;101(6):2284-99.

2.   Vadiveloo, T, et al. A Population-based study of the Epidemiology of
Chronic Hypoparathyroidism. J Bone Miner Res. 2018;33(3):478-485.

3.   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.

4.   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.

5.   Kamenicky P, et al. OR23-04 Treatment of chronic hypoparathyroidism
with eneboparatide (AZP-3601), a novel PTH 1 receptor agonist: results from a
phase 2 trial.  Journal of the Endocrine Society. 2023;7(Supplement_1):
bvad114.562.

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

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