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 December 2023
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.AstraZeneca to acquire Icosavax
News Release
Regulatory News Service
12
December 2023
AstraZeneca to acquire Icosavax, including potential first-in-class
RSV and hMPV combination vaccine with positive Phase II
data
Building on
expertise in RSV prevention, acquisition will accelerate ambition
to deliver
portfolio of protective interventions to address high unmet needs
in infectious diseases
AstraZeneca
has entered into a definitive agreement to acquire Icosavax, Inc.
(NASDAQ: ICVX), a US-based clinical-stage biopharmaceutical company
focused on developing differentiated, high-potential vaccines using
an innovative, protein virus-like particle (VLP)
platform.
The proposed 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 infection and hospitalisation in adults 60 years of age
and older and those with chronic conditions such as cardiovascular,
renal and respiratory disease.1-3 There
are currently no treatments or preventative therapies for hMPV and
no combination vaccines for RSV.4
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.5
As VLP vaccines mimic how naturally occurring
viruses appear to the body's immune system, they may offer
potential benefits over non-VLP vaccines, including a stronger
immune response, greater breadth of protection, greater durability
requiring fewer boosters and, compared to the current adjuvanted
RSV vaccine, a lower incidence of side effects.6
Alongside
Icosavax's proprietary technology and leadership in protein design,
the acquisition is expected to also bring their expertise and
capabilities in protein virus-like particle science and development
to AstraZeneca to support the progression of IVX-A12 and other
differentiated VLP vaccines for high-burden respiratory
infections.
Iskra
Reic, Executive Vice President, Vaccines & Immune Therapies,
AstraZeneca, said: "This virus-like particle vaccine technology has
the potential to transform prevention against severe infectious
diseases, including RSV and hMPV. With the addition of Icosavax's
Phase III-ready lead asset to our late-stage pipeline, we will have
a differentiated, advanced investigational vaccine, and a platform
for further development of combination vaccines against respiratory
viruses. This aligns with our strategy to deliver a portfolio of
therapies to address high unmet needs in infectious diseases, and
our ambition to protect the most vulnerable patients who have high
risk of severe outcomes."
Adam
Simpson, Chief Executive officer, Icosavax, said: "We are pleased
to announce the proposed acquisition of Icosavax by
AstraZeneca as we believe it offers the opportunity to accelerate,
and expand access to, our potential first-in-class combination
vaccine for older adults at risk of RSV and hMPV. We look forward
to combining our skills and expertise in advancing the development
of IVX-A12 with AstraZeneca's decades of experience in RSV,
resources, and capabilities in late-stage
development."
Financial considerations
Under the terms of the agreement, AstraZeneca,
through a subsidiary, will initiate a tender offer to acquire all
of Icosavax's outstanding shares for a price of $15.00 per share in
cash at closing, 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 sales milestone. The upfront cash
portion of the consideration represents a transaction value of
approximately $0.8bn, a 43% premium to Icosavax's closing market
price on 11th December
2023 and a 73% premium to the 60-day volume-weighted average price
(VWAP) of $8.68 before this announcement. Combined, the upfront and
maximum potential contingent value payments represent, if achieved,
a transaction value of approximately $1.1bn, a 91% premium to
Icosavax's closing market price on 11th December
2023 and a 130% premium to the 60-day VWAP. As part of the
transaction, AstraZeneca will acquire the cash and marketable
securities on Icosavax's balance sheet, which totaled $229m as of
30th September
2023.
Notes
Icosavax
Icosavax
is a biopharmaceutical company leveraging its innovative VLP
platform technology to develop vaccines against infectious
diseases, with an initial focus on life-threatening respiratory
diseases and a vision for combination and pan-respiratory vaccines.
Icosavax's VLP platform incorporates antigen design capabilities
and technology to enable multivalent, particle-based display of
complex viral antigens, which it believes will induce broad,
robust, and durable protection against the specific viruses
targeted. Icosavax's lead program is a combination vaccine
candidate targeting respiratory syncytial virus (RSV) and human
metapneumovirus (hMPV). Its pipeline includes additional candidates
that provide optionality as potential components of future
combination and pan-respiratory vaccines, including influenza and
SARS-CoV-2. Icosavax was formed in 2017 to advance the breakthrough
VLP technology from the Institute for Protein Design at the
University of Washington with the goal to discover, develop, and
commercialize vaccines against infectious diseases. Icosavax is
located in Seattle.
RSV and hMPV in older adults
RSV is a common, contagious virus that is a major
cause of lower respiratory tract infection in
adults.7 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.8 RSV
infection can cause serious complications such as pneumonia or
exacerbation of congestive heart failure, asthma, and chronic
obstructive pulmonary disease.7
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.4 Adults
with hMPV infection may have viral pneumonia, worsening asthma, or
COPD symptoms.9 Data
support similar morbidity and mortality for hMPV and
RSV.2 There
are currently no treatment or prevention options for
hMPV.4
IVX-A12
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.
In Icosavax's Phase II trial, IVX-A12 showed
robust immune responses across RSV and hMPV antibodies,
reconfirming previous immunogenicity data seen in the smaller Phase
I trial. The data are the first to demonstrate hMPV immune response
in a Phase II combination vaccine trial. IVX-A12 was
generally well-tolerated in the trial, with a safety profile
similar to that seen in the Phase I trial.5
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
Icosavax VLP technology
VLPs are a proven technology with multiple
products on the market, including vaccines for human papillomavirus
and hepatitis B.6 While
currently available vaccines utilise the few proteins that
naturally fold into VLPs,11 the
Icosavax 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, multivalent display of
antigens.6,11 This
technology is believed to induce a stronger and more durable immune
response versus traditional soluble antigens.6,11
Transaction details
The
closing of the tender offer will be subject to certain conditions,
including the tender of shares representing at least a majority of
the total number of Icosavax's outstanding shares, and other
customary closing conditions and regulatory clearances. Upon the
successful completion of the tender offer, AstraZeneca's
acquisition subsidiary will be merged with and into Icosavax and
any remaining shares of common stock of Icosavax will be cancelled
and converted into the right to receive the same merger
consideration (including the contingent value right) per share
payable in the tender offer. Subject to the satisfaction of the
conditions in the merger agreement, the acquisition is expected to
close in the first quarter of 2024.
Important information about the tender offer
The
tender offer for the outstanding common stock of the Company has
not yet commenced. This communication does not constitute a
recommendation, an offer to purchase or a solicitation of an offer
to sell the Company's securities. An offer to purchase shares of
the Company's common stock will only be made pursuant to an Offer
to Purchase and related tender offer materials. At the time the
tender offer is commenced, AstraZeneca PLC (AstraZeneca),
AstraZeneca Finance and Holdings Inc. and Isochrone Merger Sub
Inc., a wholly owned indirect subsidiary of AstraZeneca, will file
a Tender Offer Statement on Schedule TO with the Securities and
Exchange Commission (the SEC) and thereafter the Company will file
a Solicitation/Recommendation Statement on Schedule 14D-9 with the
SEC with respect to the tender offer. The tender offer
materials (including the Offer to Purchase, a related Letter of
Transmittal and other tender offer documents) and the
Solicitation/Recommendation Statement on Schedule 14D-9 will
contain important information.
The Company's stockholders are urged to read these documents
(including the Offer to Purchase and related Letter of Transmittal
and certain other documents), and the Solicitation/Recommendation
Statement, as may be amended from time to time, carefully when they
become available because they will contain important information
that they should consider before making any decision regarding
tendering their shares of common stock.
The tender offer materials and the
Solicitation/Recommendation Statement will be made available for
free at the SEC's website at www.sec.gov. Copies of the documents
filed with the SEC by AstraZeneca may be obtained at no charge on
the investor relations page of AstraZeneca's internet website
at www.astrazeneca.com/investors.
Copies of the documents filed with the SEC by Icosavax may be
obtained at no charge under the "Investors" section of Icosavax's
internet website at www.Icosavax.com.
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 Icosavax. Such
forward-looking statements include, but are not limited to, the
ability of AstraZeneca and Icosavax to complete the transactions
contemplated by the acquisition agreement, including the parties'
ability to satisfy the conditions to the consummation of the offer
contemplated thereby and the other conditions set forth in the
merger agreement, statements about the expected timetable for
completing the transaction, AstraZeneca's and Icosavax's beliefs
and expectations and statements about the benefits sought to be
achieved in AstraZeneca's proposed acquisition of Icosavax, the
potential effects of the acquisition on both AstraZeneca and
Icosavax, the possibility of any termination of the merger
agreement, 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 and Icosavax'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 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, uncertainties as
to the timing of the offer and the subsequent merger; uncertainties
as to how many of Icosavax's stockholders will tender their shares
in the offer; the possibility that various conditions to the
consummation of the offer and the merger contemplated by the merger
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 merger agreement and the impact of
the announcement and pendency of the transactions on Icosavax's
business; the risk that stockholder litigation in connection with
the offer or the merger may result in significant costs of defense,
indemnification and liability; 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 realized; 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 Icosavax 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 2022, 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.
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. Human
metapneumovirus. CDC.
Published 20 September 2023. Accessed 5 December
2023. https://www.cdc.gov/ncird/human-metapneumovirus.html
5. Icosavax. Press
Releases. Last Accessed 11 December 2023. https://ir.icosavax.com/press-releases
6. Tariq H, Batool S, et al.
Virus-like particles: revolutionary platforms for developing
vaccinesagainst emerging infectious
diseases. Front
Microbiol.
2022; Jan 3;12:790121.
7. RSV in Older
Adults and Adults with Chronic Medical
Conditions. CDC.
Published 7 November, 2023. Accessed 6 December
2023. https://www.cdc.gov/rsv/high-risk/older-adults.html.
8. 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.
9. Esposito S, Mastrolia MV.
Metapneumovirus Infections and Respiratory
Complications. Semin Respir Crit Care
Med. 2016
Aug;37(4):512-21.
10. Icosavax. (21 February
2023). Icosavax Granted FDA Fast Track Designation for IVX-A12.
Accessed 6 December 2023 https://ir.icosavax.com/news-releases/news-release-details/icosavax-granted-fda-fast-track-designation-ivx-a12
11. 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:
12 December 2023
|
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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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