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withdrawn from the tender offer, representing approximately 70.7%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
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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