FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of July
2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca
enters collaboration in oncology
This announcement contains inside information
27 July 2020 07:00 BST
AstraZeneca and Daiichi Sankyo enter collaboration to develop and
commercialise new antibody drug conjugate
Potential new medicine DS-1062 could redefine treatment standards
in lung, breast and multiple other cancers
AstraZeneca has entered into a new global development and
commercialisation agreement with Daiichi Sankyo Company, Limited
(Daiichi Sankyo) for DS-1062, Daiichi Sankyo's
proprietary trophoblast
cell-surface antigen 2 (TROP2)-directed
antibody drug conjugate
(ADC) and potential new medicine for the treatment of
multiple tumour types.
DS-1062 is currently in development for the treatment of multiple
tumours that commonly express the cell-surface glycoprotein TROP2.
Among them, TROP2 is overexpressed in the majority of non-small
cell lung cancers1 and
breast cancers,2,3 tumour
types that have long been a strategic focus for AstraZeneca. This
collaboration reflects AstraZeneca's strategy to invest in antibody
drug conjugates as a class, the innovative nature of the technology
and the successful existing collaboration with Daiichi
Sankyo.
Pascal Soriot, Chief Executive Officer, said: "We see significant
potential in this antibody
drug conjugate in
lung as well as
in breast and other
cancers that commonly express TROP2. We are delighted to enter this new collaboration
with Daiichi Sankyo and to build on the successful launch
of Enhertu to
further expand our pipeline and leadership
in Oncology. We
now have six potential blockbusters in Oncology with more to come
in our early and late pipelines."
Sunao Manabe, Representative Director, President and CEO of Daiichi
Sankyo, said: "DS-1062, one of our lead DXd ADCs that will form a
pillar of our next mid-term business plan, has the potential to
become a best-in-class TROP2 ADC in multiple tumours, including
lung and breast cancers. This new strategic collaboration with
AstraZeneca, a company with extensive experience and significant
expertise in the global oncology business, will enable us to
deliver DS-1062 to more patients around the world as quickly as
possible. As we have done with Enhertu, we will jointly design and implement strategies
to maximise the value of DS-1062."
Using Daiichi Sankyo's proprietary DXd ADC technology, DS-1062 is
designed to deliver chemotherapy selectively to cancer cells and to
reduce systemic exposure. A comprehensive development programme
with DS-1062 is planned globally.
Financial considerations
AstraZeneca will pay Daiichi Sankyo an upfront payment of $1bn in
staged payments: $350m is due upon completion, with $325m after 12
months and $325m after 24 months from the effective date of the
agreement.
AstraZeneca will pay additional conditional amounts of up to $1bn
for the successful achievement of regulatory approvals and up to
$4bn for sales-related milestones.
The transaction will be accounted for as an intangible asset
acquisition, recognised initially at the present value of
non-contingent consideration, with any potential future milestone
payments capitalised into the intangible asset as they are
recognised.
The companies will jointly develop and commercialise DS-1062
worldwide, except in Japan where Daiichi Sankyo will maintain
exclusive rights. AstraZeneca and Daiichi Sankyo will share equally
development and commercialisation expenses as well as profits
relating to DS-1062 worldwide, except for Japan where Daiichi
Sankyo will be responsible for such costs and will pay AstraZeneca
mid single-digit royalties. Daiichi Sankyo will record sales in the
US, certain countries in Europe and certain other countries where
Daiichi Sankyo has affiliates. Profits shared with AstraZeneca from
those countries will be recorded as Collaboration Revenue by
AstraZeneca. AstraZeneca will record Product Sales in other
countries worldwide, for which profits shared with Daiichi Sankyo
will be recorded within Cost of Sales. Daiichi Sankyo will
manufacture and supply DS-1062.
There are no closing conditions to the transaction. The
collaboration agreement became effective on 27 July 2020. The
transaction does not impact the Company's financial guidance for
2020.
TROP2
TROP2 is a transmembrane glycoprotein that is overexpressed in many
cancers including up to 80% of patients with triple-negative breast
cancer.2,3 High
TROP2 expression also has been identified in a majority of
non-small cell lung cancers.1 Research
indicates that high TROP2 expression is associated with cancer cell
growth and proliferation.4 TROP2
is recognised as a promising molecular target for therapeutic
development in various cancers.4
DS-1062
DS-1062 is a TROP2-directed ADC. ADCs are targeted cancer medicines
that deliver cytotoxic chemotherapy ('payload') via a linker
attached to a monoclonal antibody that binds to a specific target
expressed on cancer cells. Designed using Daiichi Sankyo's
proprietary DXd ADC technology, DS-1062 is comprised of a humanised
anti-TROP2 monoclonal antibody attached to a topoisomerase I
inhibitor payload by a tetrapeptide-based linker. DS-1062 is a
potential new medicine that has not been approved for any
indication in any country. Safety and efficacy have not been
established.
Collaboration between AstraZeneca and Daiichi Sankyo in
Oncology
In March
2019, AstraZeneca and Daiichi
Sankyo entered into a global collaboration to jointly develop and
commercialise Enhertu (HER2-directed ADC) worldwide, except in
Japan, where Daiichi Sankyo maintains exclusive
rights.
AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly growing portfolio of new medicines that has the potential to transform
patients' lives and the Company's future. With six new medicines
launched between 2014 and 2020, and a broad
pipeline of small molecules and biologics in development,
the Company is committed to advance oncology as a key growth driver
for AstraZeneca focused on lung, ovarian, breast and blood
cancers.
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and, one day, eliminate cancer as a cause
of death.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, 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 Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Inamura K, et al. Association of tumor TROP2 expression with
prognosis varies among lung cancer subtypes. Oncotarget. 2017; 8
(17): 28725-28735. https://dx.doi.org/10.18632%2Foncotarget.15647.
2. Zhao W, et al. Trop2 is a potential biomarker for the promotion
of EMT in human breast cancer. Oncol Rep. 2018; 40 (2):
759-766. https://doi.org/10.3892/or.2018.6496.
3. Zaman S, et al. Targeting Trop-2 in solid tumors: future
prospects. Onco Targets Ther. 2019; 12:
1781-1790. https://dx.doi.org/10.2147%2FOTT.S162447.
4. Zeng P, et al. Impact of TROP2 expression on prognosis in solid
tumors: A Systematic Review and Meta-analysis. Sci Rep. 2016; 6:
e33658. https://dx.doi.org/10.1038%2Fsrep33658.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
27 July 2020
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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