FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of July 2024
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Acquisition of Amolyt Pharma completed
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
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
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
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
15 July 2024
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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