REG - AstraZeneca PLC - AstraZeneca to acquire Icosavax

AstraZenecaAnnouncement

12/12/2023 07:15

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20231212:nRSL4665Wa&default-theme=true

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
(https://protect-de.mimecast.com/s/ZdZBC08wmMSM4mwVKuw7EM1?domain=ir.icosavax.com)
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 (http://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 (http://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
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

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
(https://www.cdc.gov/ncird/human-metapneumovirus.html)

5.   Icosavax. Press Releases. Last Accessed 11 December 2023.
https://ir.icosavax.com/press-releases
(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
(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
(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

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  ACQGPGUWPUPWUAP