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 July 2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
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United
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12g3-2(b): 82-_____________
This announcement contains inside information
27 July 2017 07:05 BST
ASTRAZENECA AND MERCK ESTABLISH STRATEGIC ONCOLOGY
COLLABORATION
Collaboration aims to maximise the potential of PARP and MEK
inhibitors in combination with PD-L1/PD-1 medicines, based on
growing scientific evidence that these combinations offer new
potential for the treatment of a range of tumour types
AstraZeneca and Merck will independently develop and commercialise
Lynparza and potential medicine selumetinib in combinations with
companies' respective
PD-L1/PD-1 immuno-oncology medicines Imfinzi and
Keytruda
Collaboration will significantly expand the potential of Lynparza,
the world's first and leading PARP inhibitor, as a backbone of
combination treatments for multiple cancer types; agreement also
includes AstraZeneca's selumetinib, a MEK inhibitor
The companies will share development and marketing costs equally,
as well as gross profits from Lynparza and selumetinib
AstraZeneca and Merck & Co., Inc., (Merck; known as MSD outside
of the US and Canada) today announced that they have entered a
global strategic oncology collaboration to co-develop and
co-commercialise AstraZeneca's Lynparza (olaparib) for multiple cancer
types.
Lynparza is an innovative,
first-in-class oral poly ADP ribose polymerase (PARP)
inhibitor currently approved for BRCA-mutated ovarian cancer in
multiple lines of treatment.
Lynparza's pipeline has grown
significantly in the last few years, with 14 indications currently
being developed across several tumour types, including breast,
prostate and pancreatic cancers. The strategic collaboration is
expected to further increase the number of treatment options
available to patients.
The companies will develop and commercialise Lynparza jointly, both as monotherapy and in combination
with other potential medicines. Independently, the companies will
develop and commercialise Lynparza in combination with their respective PD-L1 and
PD-1 medicines,
Imfinzi (durvalumab) and
Keytruda
(pembrolizumab).
The companies will also jointly develop and commercialise
AstraZeneca's selumetinib, an oral, potent, selective inhibitor of
MEK, part of the mitogen-activated protein kinase (MAPK) pathway,
currently being developed for multiple indications including
thyroid cancer.
Pascal Soriot, Chief Executive Officer of AstraZeneca, said: "Our
strategic collaboration builds on scientific evidence that PARP and
MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a
range of tumours.
By bringing together the expertise of two leading oncology
innovators, we will accelerate
Lynparza's potential to become
the preferred backbone of many immuno-oncology combination
therapies as the world's first and leading PARP inhibitor. This is
a truly exciting step and we are pleased to work with Merck, a
company that shares our passion for science to deliver new
medicines for cancer patients."
Kenneth C. Frazier, Chief Executive Officer of Merck, said: "This
global collaboration between AstraZeneca and Merck, two oncology
leaders, will increase the possibilities for patients to have more
treatment options for more cancers. Merck continues to build its
leadership in immuno-oncology with Keytruda as foundational in monotherapy and combination
therapy, and this collaboration expands our oncology leadership
into the growing targeted therapies of PARP and MEK inhibitors. We
look forward to working with AstraZeneca to create greater value
for patients and shareholders than if both companies worked
independently."
Financial considerations
Under the terms of the agreement, AstraZeneca and Merck will share
the development and commercialisation costs for Lynparza and selumetinib monotherapy and non-PD-L1/PD-1
combination therapy opportunities. Gross profits from
Lynparza
and selumetinib Product Sales
generated through monotherapies or combination therapies will be
shared equally.
Merck will fund all development and commercialisation costs
of Keytruda in combination with Lynparzaor selumetinib. AstraZeneca will fund all
development and commercialisation costs of Imfinzi in combination with Lynparza or selumetinib.
AstraZeneca
will continue to manufacture Lynparza and selumetinib.
As part
of the agreement, Merck will pay AstraZeneca up to $8.5 billion in
total consideration, including $1.6 billion upfront, $750 million
for certain license options and up to $6.15 billion contingent upon
successful achievement of future regulatory and sales
milestones.Under the terms of the agreement, AstraZeneca
anticipates approximately $1 billion to be recorded under
Externalisation Revenue in 2017.
AstraZeneca will book all Product Sales of Lynparza and selumetinib; gross profits due to Merck under
the collaboration will be recorded under Cost of Sales. The
initial, regulatory and commercial milestone payments will be
recorded under Externalisation Revenue. The transaction does not
impact AstraZeneca's 2017 financial guidance. AstraZeneca continues
to anticipate that the sum of Externalisation Revenue and Other
Operating Income in FY 2017 will be ahead of that in FY
2016.
The collaboration agreement was completed upon signing on 26 July
2017.
For the purposes of the UK Listing Authority's Listing Rule LR
10.4.1 R (Notification of class 2 transactions), the book value of
gross assets subject to the license and collaboration is
approximately $242 million. In view of the development and early
growth phase of the medicines, a pre-tax loss of $231 million was
attributable to Lynparza and selumetinib in aggregate in the year to 31
December 2016.
About Lynparza
Lynparza (olaparib) is an innovative, first-in-class oral poly
ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DDR
pathway deficiencies to preferentially kill cancer
cells.
Lynparza is the foundation of
AstraZeneca's industry-leading portfolio of potential new
medicines that target DDR mechanisms in cancer cells.
Lynparza
is currently approved by regulatory
health authorities in the EU for use as monotherapy for the
maintenance treatment of adult patients with platinum-sensitive,
relapsed BRCA-mutated (germline and/or somatic), high-grade serous
epithelial ovarian, fallopian tube or primary peritoneal cancer,
who are in response (complete or partial) to platinum-based
chemotherapy. It is also approved in the US as a monotherapy for
patients with deleterious, or suspected deleterious, germline
BRCA-mutated (as detected by a US FDA test) advanced ovarian
cancer, who have been treated with three or more lines of
chemotherapy.
The Company recently presented positive results for
Lynparza
from its Phase III OlympiAD trial that
showed a statistically-significant and clinically-meaningful
improvement in progression-free survival for patients treated
with Lynparza tablets (300mg twice daily), compared to treatment
with physician's choice of a standard of care chemotherapy.
OlympiAD, a randomised, open label, multi-centre Phase III trial
assessing the efficacy and safety of Lynparza in patients with HER2-negative metastatic breast
cancer with germline BRCA1 or BRCA2 mutations, which are predicted
or suspected to be deleterious, was the first positive Phase III
trial to evaluate the efficacy and safety of PARP inhibitor beyond
ovarian cancer. Lynparza is currently being investigated in another
separate non-metastatic breast cancer Phase III trial called
OLYMPIA. This trial is still open and recruiting patients
internationally.
Lynparza generated Product
Sales in 2016 of $218 million.
About selumetinib
Selumetinib, licensed by AstraZeneca from Array BioPharma Inc. in
2003, inhibits the MEK enzyme in the RAS/RAF/MEK/ERK pathway in
cancer cells to prevent the tumour from growing. Selumetinib is in
Phase III development for differentiated thyroid cancer, for which
it was granted Orphan Drug Designation by the FDA in May
2016.
Selumetinib is also being tested in a separate Phase II trial in
patients with paediatric neurofibromatosis type-1, and in a Phase I
trial with patients suffering from advanced solid
tumours.
About 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 at least six new
medicines to be launched between 2014 and 2020, and a broad
pipeline of small molecules and biologics in development, we are
committed to advance New Oncology as one of AstraZeneca's five
Growth Platforms focused on lung, ovarian, breast and blood
cancers. In addition to our core capabilities, we actively pursue
innovative partnerships and investments that accelerate the
delivery of our strategy as illustrated by our investment in Acerta
Pharma in haematology.
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.
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 main therapy areas - Oncology, Cardiovascular &
Metabolic Diseases and
Respiratory. The Company also is selectively active in the areas of
autoimmunity, neuroscience and infection. AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information, please
visit www.astrazeneca.com
and follow us on Twitter
@AstraZeneca.
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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.
AstraZeneca
PLC
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Date:
27 July 2017
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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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