Blueprint
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 March
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AZ
and Daiichi Sankyo enter collaboration in novel
This announcement contains inside information
The securities proposed to be offered pursuant to the equity
placing referred to herein will not be and have not been registered
under the US Securities Act of 1933, as amended, and may not be
offered or sold in the United States absent registration or an
applicable exemption from registration requirements.
28 March 2019 23:30 GMT
AstraZeneca and Daiichi Sankyo enter collaboration
for novel HER2-targeting antibody-drug
conjugate
Companies to accelerate and expand development of trastuzumab
deruxtecan across breast and other cancers, with the potential to
redefine standard of care
Funding via an equity placement of approximately
$3.5bn
Guidance for 2019 Core Earnings Per Share remains unchanged;
growing accretion from 2020 to a significant contribution in
2023
AstraZeneca has entered into a global development and
commercialisation collaboration agreement with Daiichi Sankyo
Company, Limited (Daiichi Sankyo) for trastuzumab deruxtecan
(DS-8201), a proprietary antibody-drug conjugate (ADC) and
potential new targeted medicine for cancer treatment.
The collaboration is aligned with AstraZeneca's science-led
strategy in Oncology, which is based on four key scientific
platforms: tumour drivers & resistance, DNA damage response,
Immuno-Oncology and ADCs.
Trastuzumab deruxtecan is currently in development for the
treatment of multiple HER2-expressing
cancers, including breast and gastric cancer, and in patients
with HER2-low
expression. In 2017, trastuzumab deruxtecan was granted
Breakthrough Therapy Designation by the US FDA for the treatment of
patients with HER2-positive,
locally-advanced or metastatic breast cancer who have been treated
with trastuzumab and pertuzumab and have disease progression after
trastuzumab emtansine.
A first regulatory submission is scheduled for the second half of
2019 for patients in the advanced or refractory breast cancer
setting. Additional development for the treatment of breast,
non-small cell lung cancer (NSCLC), gastric and colorectal cancers
is ongoing.
The companies will jointly develop and commercialise
trastuzumab
deruxtecan worldwide,
except in Japan where Daiichi Sankyo will maintain exclusive
rights. Daiichi Sankyo will be solely responsible for manufacturing
and supply.
Pascal Soriot, Chief Executive Officer, said: "We believe that
trastuzumab deruxtecan could become a transformative new medicine
for the treatment of HER2-positive
breast and gastric cancers. In addition, it has the potential to
redefine breast cancer treatment as the first therapy
forHER2-low
expressing tumours. It also has the potential to treat
other HER2-mutated
or HER2-overexpressing
cancers, including lung and colorectal cancers. We are proud to be
working with Daiichi Sankyo, a long-term collaborator of
AstraZeneca in other disease areas."
George Nakayama, Representative Director, Chairman and Chief
Executive Officer of Daiichi Sankyo, said: "Trastuzumab
deruxtecan is the flagship asset in our oncology pipeline created
by our relentless pursuit of science and technology, the most
important strengths of our company. Through the strategic
collaboration with AstraZeneca, a company with a wealth of global
experience and expertise in oncology, we will combine our
respective skill sets to maximise the value of trastuzumab
deruxtecan and accelerate the establishment of our global oncology
business. By aiming to provide new treatment options across a wide
range of cancers as soon as possible, we will maximise our
contribution to patients with cancer and their families around the
world."
Using Daiichi Sankyo's DXd proprietary ADC
technology, trastuzumab
deruxtecan has been
designed to deliver chemotherapy selectively to cancer cells and
reduce systemic exposure, in contrast to conventional chemotherapy
delivery. Data from the ongoing first-time-in-human trial shows
strong activity in a number of tumour types. In particular, the
strength of the overall response rate and durability of response in
patients previously treated with trastuzumab emtansine
for HER2-positive metastatic breast cancer formed the
basis for the Breakthrough Therapy Designation.1
Financial considerations
Under the terms of the agreement, AstraZeneca will pay Daiichi
Sankyo an upfront payment of $1.35bn, half of which is due upon
execution, with the remainder payable 12 months later.
Contingent payments of up to $5.55bn include $3.8bn for potential
successful achievement of future regulatory and other milestones,
as well as $1.75bn for sales-related milestones.
Overall, the transaction will be accounted for as an intangible
asset acquisition, recognised initially at the present value of
non-contingent consideration, with future milestones capitalised
into the intangible asset as they are recognised. AstraZeneca and
Daiichi Sankyo will share equally development and commercialisation
costs as well as profits from trastuzumab deruxtecan worldwide,
except for Japan.
Daiichi Sankyo will record sales in the US, certain countries in
Europe and certain other markets where Daiichi Sankyo has
affiliates. Further to the financial reporting announcement below,
profits shared with AstraZeneca will be accounted for as
Collaboration Revenue by AstraZeneca (see further below, 'Financial
reporting presentation').
AstraZeneca is expected to record Product Sales in all other
markets worldwide for which profits shared with Daiichi Sankyo will
be accounted for as cost of goods sold.
The transaction is expected to be neutral to core earnings in 2019,
with growing Core EPS accretion from 2020 and making a significant
contribution in 2023. There are no closing conditions to the
transaction. The collaboration agreement will become effective on
29 March 2019. The transaction and funding arrangements do not
impact the Company's financial guidance for 2019 as published on 14
February 2019.
The upfront payment and near-term milestones under the transaction
will be funded from the proceeds of a new equity placement of
approximately $3.5bn, of which more than half will be used to fund
this transaction and the ongoing collaboration. A separate
announcement will be issued by the Company today on the equity
placement.
For the purposes of the UK Listing Authority's Listing Rule LR
10.4.1 R (Notification of class 2 transactions), the value of gross
assets acquired with the transaction is estimated to be $1.5bn and,
in view of the development phase of the medicine, a pre-tax loss of
$38m was attributable to trastuzumab
deruxtecan during the year
to 31 March 2018.
About Trastuzumab deruxtecan
Trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in
US only) is the lead potential new medicine in the ADC franchise of
the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer
medicines that deliver cytotoxic agents to cancer cells via a
linker attached to a monoclonal antibody that binds to a specific
target expressed on cancer cells.
A broad and comprehensive development programme with trastuzumab
deruxtecan is underway in North America, Europe and Asia, including
five pivotal trials in HER2-expressing breast and gastric cancers.
Trastuzumab deruxtecan is also in Phase II development
for HER2-expressing advanced colorectal cancer and
metastatic non-squamous HER2-overexpressing or HER2-mutated NSCLC, and Phase I development in
combination with nivolumab for HER2-expressing metastatic breast and bladder
cancers.
Trastuzumab deruxtecan was granted Breakthrough Therapy Designation
in 2017 by the US FDA for the treatment of patients
with HER2-positive, locally-advanced or metastatic breast
cancer who have been treated with trastuzumab and pertuzumab and
have disease progression after trastuzumab emtansine. Fast Track
Designation was also granted in the US for the treatment
of HER2-positive unresectable and/or metastatic breast
cancer in patients who have progressed after prior treatment
with HER2-targeted medicines, including trastuzumab
emtansine. Trastuzumab deruxtecan has received Sakigake designation
for the treatment of HER2-positive advanced gastric or gastroesophageal
junction cancer by the Japan Ministry of Health, Labour and
Welfare.
Trastuzumab deruxtecan is a potential new medicine that has not
been approved for any indication in any country. Safety and
efficacy have not been established.
Financial reporting presentation
As a result of this announcement, AstraZeneca also updates the
presentation of Total Revenue within its Statement of Comprehensive
Income. This is effective from 1 January 2019 and will be reflected
in the Company's Q1 2019 financial results that are intended for
publication on 26 April 2019.
In 2015, the Company announced a change to the presentation of
Total Revenue within its Statement of Comprehensive Income to
include Externalisation Revenue. Today's announcement recognises
the growing importance of collaborations to AstraZeneca and will
result in income arising from those collaborations being recognised
within Total Revenues. The associated costs of collaborations will
be recognised in the appropriate expense lines in the Statement of
Comprehensive Income.
Historically, Externalisation Revenue only included income arising
from transactions involving AstraZeneca's medicines. Such income
included upfronts, milestones receipts and royalties, as well as
other income from collaborations. The updated category of
Collaboration Revenue will also include income of a similar nature
arising from transactions where AstraZeneca has acquired an
interest in a medicine and entered into an active collaboration
with the seller.
No prior year restatement of financial results will be required as
a result of this change. The change in accounting presentation does
not impact the Company's revenue guidance for 2019.
About AstraZeneca
AstraZeneca 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. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information, please
visit astrazeneca.com and
follow us on Twitter@AstraZeneca.
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References
1
Iwata H, et al. Trastuzumab Deruxtecan (DS-8201a) in Subjects with
HER2-expressing Solid Tumors: Long-term Results of a Large Phase 1
Study with Multiple Expansion Cohorts. Presented at the American
Society of Clinical Oncology. Chicago, USA. 1 June
2018.
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:
29 March
2019
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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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