REG - AstraZeneca PLC - Acquisition of Amolyt Pharma completed

AstraZenecaAnnouncement

15/07/2024 07:00

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RNS Number : 2924W  AstraZeneca PLC  15 July 2024

15 July 2024

 

Acquisition of Amolyt Pharma completed

 

AstraZeneca today announced the successful completion of the acquisition
(https://www.astrazeneca.com/media-centre/press-releases/2024/astrazeneca-to-acquire-amolyt.html)
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 (https://www.astrazeneca.com/)

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 (http://www.astrazeneca.com/)  and follow the
Company on social media @AstraZeneca
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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.  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

 

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