a8420g
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 March 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.
AstraZeneca to acquire Amolyt
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.
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 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. 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
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:
14 March 2024
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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