TIDMAZN
RNS Number : 4665W
AstraZeneca PLC
12 December 2023
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 11(th) 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 11(th) 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 30(th) 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
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