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 February 2024
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
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contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
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assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca completes acquisition of Icosavax
19 February 2024
Acquisition of Icosavax Completed
AstraZeneca announced today the successful completion of the
acquisition of Icosavax, Inc., a US-based clinical-stage
biopharmaceutical company focused on developing differentiated,
high-potential vaccines using an innovative, protein virus-like
particle (VLP) platform. As a result of the acquisition, Icosavax
has become a subsidiary of AstraZeneca, with operations in Seattle,
US.
The acquisition will build on AstraZeneca's expertise in
respiratory syncytial virus (RSV), strengthening AstraZeneca's
Vaccines & Immune Therapies late-stage pipeline with Icosavax's
lead investigational vaccine candidate, IVX-A12. IVX-A12 is a
potential first-in-class, Phase III-ready, combination protein VLP
vaccine which targets both RSV and human metapneumovirus (hMPV),
two leading causes of severe respiratory infections and
hospitalisations in adults 60 years of age and older and those with
chronic conditions such as cardiovascular, renal and respiratory
disease.1-3
The acquisition was completed through a tender offer to purchase
all outstanding shares of Icosavax for a price of $15.00 per share
in cash up front, plus a non-tradable contingent value right for up
to $5.00 per share in cash, payable upon achievement of a specified
regulatory milestone and a specified sales milestone, which was
followed by a statutory merger through which all shares of Icosavax
stock that had not been validly tendered were converted into the
right to receive the same consideration.
Combined, the upfront and contingent value rights payments, if
achieved, represent a transaction value of approximately $1.1bn. As
of the expiration of the tender offer, 35,912,932 shares of
Icosavax were validly tendered and not validly withdrawn from the
tender offer, representing approximately 70.7% of the outstanding
shares of common stock of Icosavax, and such shares have been
accepted for payment and will be paid for promptly in accordance
with the terms of the tender offer. Icosavax shares will be
delisted from the Nasdaq Stock Market, and Icosavax will terminate
its registration under the U.S. Securities Exchange Act of
1934.
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 Icosavax. Such
forward-looking statements include, but are not limited to,
AstraZeneca's beliefs and expectations and statements about the
benefits sought to be achieved in AstraZeneca's acquisition of
Icosavax, the potential effects of the acquisition on AstraZeneca,
as well as the expected benefits and success of IVX-A12 and any
combination product. These statements are based upon the current
beliefs and expectations of AstraZeneca's management and are
subject to significant risks and uncertainties. There can be no
guarantees that IVX-A12 or any further vaccines using the VLP
technology 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, the
possibility that the achievement of the specified milestones
described in the contingent value rights agreement may take longer
to achieve than expected or may never be achieved and the resulting
contingent milestone payments 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.
AstraZeneca undertakes no 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 Reports on Form 20-F for the years ended 31
December 2022 and 31 December 2023, Icosavax's Annual Report on
Form 10-K for the year ended 31 December 2022 and Icosavax's
Quarterly Reports on Form 10-Q for the three months ended 31 March
2023, 30 June 2023 and 30 September 2023, in each case as amended
by any subsequent filings made with the SEC. These and other
filings made by AstraZeneca and Icosavax with the SEC are available
at www.sec.gov.
Notes
RSV and hMPV in older adults
RSV is a common, contagious virus that is a major cause of lower
respiratory tract infection in adults.4 Most
adult RSV disease cases occur among older adults, with an estimated
60,000-160,000 hospitalisations and 6,000-10,000 deaths annually
among US adults >65 years of age.5 RSV
infection can cause serious complications such as pneumonia or
exacerbation of congestive heart failure, asthma, and chronic
obstructive pulmonary disease.4
hMPV causes disease very similar to RSV, including upper and lower
respiratory tract infections that can be more severe in young
children, older adults, and people with weakened immune
systems.6 Adults
with hMPV infection may have viral pneumonia, worsening asthma, or
COPD symptoms.7 Data
support similar morbidity and mortality for hMPV and
RSV.2 There
are currently no treatment or preventative therapies for hMPV and
no combination vaccines for RSV.4,8
IVX-A12
IVX-A12 is the most advanced investigational vaccine targeting both
RSV and hMPV and has a differentiated profile versus currently
approved RSV vaccines. Phase II data demonstrate that IVX-A12
elicits robust immune responses against both RSV and hMPV one month
after vaccination and reconfirm previous immunogenicity data seen
in the Phase I trial.9 The
data are the first to demonstrate hMPV immune response in a Phase
II combination vaccine trial.9 IVX-A12
was generally well-tolerated in the trial, with a safety profile
similar to that seen in the Phase I trial.9
IVX-A12 is a liquid, refrigerator-stable formulation comprised of
IVX-121, Icosavax's RSV prefusion F protein VLP vaccine candidate,
and IVX-241, Icosavax's hMPV prefusion F protein VLP vaccine
candidate.
IVX-A12 has been granted Fast Track Designation from the US Food
and Drug Administration, a programme designed to facilitate the
development and expedite the review of investigational drugs to
treat serious conditions and fulfill an unmet medical
need.10
VLP technology
VLPs are a proven technology with multiple products on the market,
including vaccines for human papillomavirus and hepatitis
B.11 While
currently available vaccines utilise the few proteins that
naturally fold into VLPs,12 the
protein VLP platform builds on that success with intentionally
designed VLPs to create highly differentiated
vaccines.
VLPs are designed to resemble the structure of viruses, with
high-density display of antigens.10,11 This
technology is believed to induce a stronger and more durable immune
response versus traditional soluble antigens.10,11
Through its ability to more effectively present antigens to the
immune system, the VLP platform offers the ability to further
innovate and bring next-generation respiratory combination vaccines
to market.
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.
Sieling WD, Goldman CR, et al. Comparative
incidence and burden of respiratory viruses associated with
hospitalization in adults in New York
City. Influenza
Resp Viruses.
2021;15(5):670-677. doi:10.1111/irv.12842
2.
Widmer K, Zhu Y, et al. Rates of hospitalizations
for respiratory syncytial virus, human metapneumovirus, and
influenza virus in older adults. J Infect
Dis. 2012;206(1):56-62.
doi:10.1093/infdis/jis309
3.
Jain S, Self WH, et al. Community-Acquired
Pneumonia Requiring Hospitalization among U.S.
Adults. N Engl J
Med. 2015 Jul
30;373(5):415-27.
4.
RSV in Older Adults and Adults
with Chronic Medical Conditions. CDC.
Published 7 November 2023. Accessed 15 February
2024. https://www.cdc.gov/rsv/high-risk/older-adults.html.
5.
Havers FP, Whitaker M, et al. Characteristics and
Outcomes Among Adults Aged ≥60 Years Hospitalized with
Laboratory-Confirmed Respiratory Syncytial Virus - RSV-NET, 12
States, July 2022-June 2023. MMWR Morb Mortal Wkly
Rep. 2023 Oct
6;72(40):1075-1082.
6.
Human
metapneumovirus. CDC.
Published 20 September 2023. Accessed 15 February
2024 https://www.cdc.gov/ncird/human-metapneumovirus.html
7.
Esposito S, Mastrolia MV. Metapneumovirus
Infections and Respiratory Complications. Semin Respir Crit Care
Med. 2016
Aug;37(4):512-21.
8.
RSV Vaccination for Older Adults
60 Years of Age and Over. CDC.
Published 30 August 2023. Accessed 15 February
2024. https://www.cdc.gov/vaccines/vpd/rsv/public/older-adults.html
9.
Icosavax [press release].
Icosavax Announces Positive Topline Interim Phase 2 Results for
Combination VLP Vaccine Candidate IVX-A12 Against RSV and hMPV in
Older Adults. 12 December 2023. Accessed 15 February
2024. https://ir.icosavax.com/news-releases/news-release-details/icosavax-announces-positive-topline-interim-phase-2-results.
10.
Icosavax [press release].
Icosavax Granted FDA Fast Track Designation for IVX-A12. 21
February 2023. Accessed 15 February 2024. https://ir.icosavax.com/news-releases/news-release-details/icosavax-granted-fda-fast-track-designation-ivx-a12.
11.
Tariq H, Batool S, et al. Virus-like particles:
revolutionary platforms for developing vaccines against emerging
infectious diseases. Front
Microbiol. 2022; Jan
3;12:790121.
12.
Nooraei, S, Bahrulolum H, et al. Virus-like
particles: preparation, immunogenicity and their roles as
nanovaccines and drug nanocarriers. J
Nanobiotechnol. 2021;19(59).
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:
19 February 2024
|
|
By: /s/
Adrian Kemp
|
|
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Name:
Adrian Kemp
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|
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Title:
Company Secretary
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