22 February 2024
Acquisition of Gracell completed
AstraZeneca today announced the successful
completion of the
acquisition of Gracell Biotechnologies Inc. (Gracell, NASDAQ:
GRCL), a global clinical-stage biopharmaceutical company developing
innovative cell therapies for the treatment of cancer and
autoimmune diseases, furthering AstraZenecaÕs cell therapy
ambition.
The acquisition enriches AstraZenecaÕs growing
pipeline of cell therapies with GC012F, a novel, clinical-stage
FasTCAR-enabled BCMA and CD19 dual-targeting autologous chimeric
antigen receptor T-cell (CAR-T) therapy. GC012F is a potential new
treatment for multiple myeloma, as well as other haematologic
malignancies and autoimmune diseases including
systemic lupus erythematosus (SLE).
Gracell will operate as a wholly
owned subsidiary of AstraZeneca, with operations in China and the
US.
Financial considerations
Under the terms of the definitive
agreement, AstraZeneca has acquired all of GracellÕs fully diluted
share capital (including shares represented by ADSs) through a
merger for a price of $2.00 per ordinary share in cash at closing
(equivalent to $10.00 per ADS of Gracell) plus a non-tradable
contingent value right of $0.30 per ordinary share (equivalent to
$1.50 per ADS of Gracell) in cash payable upon achievement of a
specified regulatory milestone.
The upfront cash portion of the
consideration represents a transaction value of approximately
$1.0bn. Combined, the upfront and potential contingent value
payments represent, if achieved, a transaction value of
approximately $1.2bn.
Notes
About
GC012F
GC012F is GracellÕs FasTCAR-enabled BCMA/CD19
dual-targeting autologous CAR-T cell therapy, which aims to
transform cancer and autoimmune disease treatment by seeking to
drive deep and durable responses with an improved safety profile.
GC012F is currently being evaluated in clinical studies in multiple
haematologic malignancies and autoimmune diseases. Gracell has
initiated a Phase Ib/II trial evaluating GC012F for the treatment
of relapsed or refractory multiple myeloma in the US.
AstraZeneca in haematology
AstraZeneca is pushing the
boundaries of science to redefine care in haematology. We have
expanded our commitment to patients with haematologic conditions,
not only in oncology but also in rare diseases with the acquisition
of Alexion, allowing us to reach more patients with high unmet
needs. By applying our deep understanding of blood cancers,
leveraging our strength in solid tumour oncology and delivering on
AlexionÕs pioneering legacy in complement science to provide
innovative medicines for rare diseases, we are pursuing the
end-to-end development of novel therapies designed to target
underlying drivers of disease.
By targeting haematologic conditions
with high unmet medical needs, we aim to deliver innovative
medicines and approaches to improve patient outcomes. Our goal is
to help transform the lives of patients living with malignant, rare
and other related haematologic diseases, shaped by insights from
patients, caregivers and physicians to have the most meaningful
impact.
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.
AstraZeneca in BioPharmaceuticals: Respiratory and
Immunology
Respiratory & Immunology, part of AstraZeneca
BioPharmaceuticals, is a key disease area and growth driver to the
Company.
AstraZeneca is an established leader
in respiratory care with a 50-year heritage and a growing portfolio
of medicines in immune-mediated diseases. The Company is committed
to addressing the vast unmet needs of these chronic, often
debilitating, diseases with a pipeline and portfolio of inhaled
medicines, biologics and new modalities aimed at previously
unreachable biologic targets. Our ambition is to deliver
life-changing medicines that help eliminate COPD as a leading cause
of death, eliminate asthma attacks and achieve clinical remission
in immune-mediated diseases.
With common pathways and underlying
disease drivers across respiratory and immunology, AstraZeneca is
following the science from chronic lung diseases to
immunology-driven disease areas. The CompanyÕs growing presence in
immunology is focused on five mid- to late-stage franchises with
multi-disease potential, in areas including rheumatology (including
SLE), dermatology, gastroenterology, and systemic
eosinophilic-driven diseases. AstraZenecaÕs ambition in Respiratory
& Immunology is to achieve disease modification and durable
remission for millions of patients worldwide.
Forward-looking
statements
This announcement may include statements that
are not statements of historical fact, or Òforward-looking
statements,Ó including with respect to AstraZenecaÕs acquisition of
Gracell. Such forward-looking statements include, but are not
limited to, AstraZenecaÕs beliefs and expectations and statements
about the benefits sought to be achieved in AstraZenecaÕs
acquisition of Gracell, the potential effects of the acquisition on
AstraZeneca, as well as the expected benefits and success of GC012F
and any combination product. These statements are based upon the
current beliefs and expectations of AstraZenecaÕs management and
are subject to significant risks and uncertainties. There can be no
guarantees that GC012F or any further products using the
FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell
therapy 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
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.
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 AstraZenecaÕs Annual Report on Form 20-F
for the year ended 31 December 2023, and GracellÕs Annual Report on Form 20-F for the year ended 31 December
2022, in each case as amended by any subsequent filings made
with the SEC. These and other filings made by AstraZeneca and
Gracell 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
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Adrian Kemp
Company Secretary
AstraZeneca PLC