Includes actinium-based clinical-stage
radioconjugate targeting PSMA for prostate cancer, pipeline of
radioconjugates and state-of-the-art R&D and manufacturing
facilities
AstraZeneca has entered into a definitive agreement to acquire
Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical
company developing next-generation radioconjugates (RCs). The
acquisition marks a major step forward in AstraZeneca delivering on
its ambition to transform cancer treatment and outcomes for
patients by replacing traditional regimens like chemotherapy and
radiotherapy with more targeted treatments.
RCs have emerged as a promising modality in cancer treatment
over recent years. These medicines deliver a radioactive isotope
directly to cancer cells through precise targeting using molecules
such as antibodies, peptides or small molecules. This approach has
many potential advantages compared to traditional radiotherapy
including minimising damage to healthy cells and enabling access to
tumours not reachable through external beam radiation.
This acquisition complements AstraZeneca's leading oncology
portfolio with the addition of the Fusion pipeline of RCs,
including their most advanced programme, FPI-2265, a potential new
treatment for patients with metastatic castration-resistant
prostate cancer (mCRPC). FPI-2265 targets prostate-specific
membrane antigen (PSMA), a protein that is highly expressed in
mCRPC, and is currently in a Phase II trial.
The acquisition brings new expertise and pioneering R&D,
manufacturing and supply chain capabilities in actinium-based RCs
to AstraZeneca. It also strengthens the Company’s presence in and
commitment to Canada.
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: “Between thirty and fifty per cent of patients
with cancer today receive radiotherapy at some point during
treatment, and the acquisition of Fusion furthers our ambition to
transform this aspect of care with next-generation radioconjugates.
Together with Fusion, we have an opportunity to accelerate the
development of FPI-2265 as a potential new treatment for prostate
cancer, and to harness their innovative actinium-based platform to
develop radioconjugates as foundational regimens.”
John Valliant, Chief Executive Officer, Fusion, said: “This
acquisition combines Fusion’s expertise and capabilities in
radioconjugates, including our industry-leading radiopharmaceutical
R&D, pipeline, manufacturing and actinium-225 supply chain,
with AstraZeneca’s leadership in small molecules and biologics
engineering to develop novel radioconjugates. Expanding on our
existing collaboration with AstraZeneca where we have advanced
FPI-2068, an EGFR-cMET targeted radioconjugate into Phase I
clinical trials, gives us a unique opportunity to accelerate the
development of next-generation radioconjugates with the aim of
transforming patient outcomes.”
Fusion will become a wholly owned subsidiary of AstraZeneca,
with operations continuing in Canada and the US.
Financial considerations
Under the terms of the definitive agreement, AstraZeneca,
through a subsidiary, will acquire all of Fusion’s outstanding
shares pursuant to a plan of arrangement for a price of $21.00 per
share in cash at closing plus a non-transferable contingent value
right of $3.00 per share in cash payable upon the achievement of a
specified regulatory milestone. The upfront cash portion of the
consideration represents a transaction value of approximately $2bn,
a 97% premium to Fusion’s closing market price of $10.64 on 18th
March 2024 and an 85% premium to the 30-day volume-weighted average
price (VWAP) of $11.37 before this announcement. Combined, the
upfront and maximum potential contingent value payments represent,
if achieved, a transaction value of approximately $2.4bn, a 126%
premium to Fusion’s closing market price on 18th March 2024 and a
111% premium to the 30-day VWAP. As part of the transaction,
AstraZeneca will acquire the cash, cash equivalents and short term
investments on Fusion’s balance sheet, which totalled $234m as of
31st December 2023.
The transaction is expected to close in the second quarter of
2024, subject to customary closing conditions, including the
approval of Fusion shareholders and regulatory clearances.
Notes
Radioconjugates in oncology
RCs combine the precise targeting of antibodies, small molecules
or peptides with potent medical radioisotopes to deliver radiation
directly to cancer cells. By seeking out cancer cells, RCs provide
a more precise mechanism of cancer cell killing compared with
traditional radiation therapy, with the goal of improving efficacy
while minimising toxicity on healthy cells. RCs are administered
via systemic delivery, which enables their use in tumour types not
accessible to external beam radiation and the targeting of cancer
cells that have spread from the main tumour to other sites in the
body.
About FPI-2265
FPI-2265 is an actinium-225 based PSMA-targeting RC for mCRPC,
currently in a Phase II trial.
Actinium-225 emits alpha particles and holds the promise of
being a next-generation radioisotope in cancer treatment. By
delivering a greater radiation dose over a shorter distance, alpha
particles such as actinium-225 have the potential for more potent
cancer cell killing, and targeted delivery, thereby minimising
damage to surrounding healthy tissue.
About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company
focused on developing next-generation RCs. Fusion connects alpha
particle emitting isotopes to various targeting molecules to
selectively deliver the alpha emitting payloads to tumours.
Fusion’s clinical-stage development portfolio includes lead
programme, FPI-2265, targeting PSMA for mCRPC and novel RCs
targeting solid tumours.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the
ambition to provide cures for cancer in every form, following the
science to understand cancer and all its complexities to discover,
develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyse changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
Additional information and where to find it
In connection with the proposed transaction, Fusion intends to
file a proxy circular with the Securities and Exchange Commission
(SEC). INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY
CIRCULAR IN ITS ENTIRETY IF AND WHEN IT BECOMES AVAILABLE AND ANY
OTHER DOCUMENTS FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED
TRANSACTION OR INCORPORATED BY REFERENCE IN THE PROXY CIRCULAR
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTION AND RELATED MATTERS.
Investors and security holders will be able to obtain free
copies of the proxy statement and other relevant documents, when
such documents are filed with the SEC, on 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/investor-relations.html. Copies of the
documents filed with the SEC by Fusion may be obtained at no charge
under the “Investors & Media” section of Fusion’s website at
https://ir.fusionpharma.com/sec-filings.
Participants in the solicitation
This communication does not constitute an offer to buy or sell
or the solicitation of an offer to buy or sell any securities or a
solicitation of any vote or approval. This communication is not a
substitute for any circular Fusion may file with the SEC in
connection with the proposed transaction.
AstraZeneca, its directors and certain of its executive officers
and other employees may, under the rules of the SEC, be deemed to
be participants in the solicitation of proxies in connection with
the proposed transaction. Information regarding such persons,
including a description of their respective direct or indirect
interests, by security holdings or otherwise, will be included in
the proxy statement when it is filed with the SEC. Information
about AstraZeneca’s directors and executive officers is also
available in AstraZeneca’s Form 20-F filed with the SEC on 20th
February 2024, and other documents subsequently filed by
AstraZeneca with the SEC. These documents will be available free of
charge from the sources indicated above.
Fusion, its directors and certain of its executive officers and
other employees may, under the rules of the SEC, be deemed to be
participants in the solicitation of proxies in connection with the
proposed transaction. Information regarding such persons, including
a description of their respective direct or indirect interests, by
security holdings or otherwise, will be included in the proxy
statement when it is filed with the SEC. Information about Fusion’s
directors and executive officers is also available in Fusion’s Form
10-K filed with the SEC on 16th March 2023, Fusion’s proxy
statement for its annual meeting of shareholders, which was filed
with the SEC on 27th April 2023, and other documents subsequently
filed by Fusion with the SEC. These documents will be available
free of charge from the sources indicated above.
Forward-looking statements
This document may include statements that are not statements of
historical fact, or “forward-looking statements,” including with
respect to the proposed acquisition of Fusion by AstraZeneca. Such
forward looking statements include, but are not limited to, the
ability of AstraZeneca and Fusion to complete the transactions
contemplated by the arrangement agreement, including the parties’
ability to satisfy the conditions set forth in the arrangement
agreement, statements about the expected timetable for completing
the transaction, AstraZeneca’s and Fusion’s beliefs and
expectations and statements about the benefits sought to be
achieved in AstraZeneca’s proposed acquisition of Fusion, the
potential effects of the acquisition on both AstraZeneca and
Fusion, the possibility of any termination of the arrangement
agreement, as well as the expected benefits and success of FPI
2265, and other pipeline product or any combination product. These
statements are based upon the current beliefs and expectations of
AstraZeneca’s and Fusion’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 FPI-2265
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 proposed transaction;
uncertainties as to how many of Fusion’s shareholders will vote in
favour of the proposed transaction; the possibility that various
conditions to the consummation of the proposed transaction 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 arrangement agreement and the impact of the
announcement and pendency of the transactions on Fusion’s business;
the risk that shareholder litigation in connection with the
proposed transaction may result in significant costs of defence,
indemnification and liability; the possibility that the achievement
of the specified milestone described in the contingent value rights
agreement may take longer to achieve than expected or may never be
achieved and the resulting contingent milestone payment 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.
Neither AstraZeneca nor Fusion 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 31st December 2023 and Fusion’s Annual Report on
Form 10 K for the year ended 31st December 2023, in each case as
amended by any subsequent filings made with the SEC. These and
other filings made by AstraZeneca and Fusion 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, Respiratory &
Immunology and Vaccines & Immune Therapies. 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
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Flavia Garcia +44 (0)1223 344 800 Global Media Mailbox:
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