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 October
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca
Extends Innate Pharma Collaboration
This announcement contains inside information
23 October 2018 07:00 BST [CBR issued at 06:00 BST]
AstraZeneca strengthens and expands oncology
development
and commercialisation collaboration with Innate Pharma
Full oncology rights to monalizumab
Access to Innate Pharma's anti-CD39 monoclonal
antibody,
IPH5201, plus four additional immuno-oncology
molecules
Innate Pharma acquires US and EU rights to commercialise
Lumoxiti
Purchase of newly-issued 9.8% equity stake in Innate
Pharma
AstraZeneca, and its global biologics research and development arm
MedImmune, today announced a new multi-term agreement with Innate
Pharma (Innate), building on an existing collaboration, aimed at
accelerating each company's oncology portfolio and bringing new
medicines to patients more quickly. The extended collaboration will
enrich AstraZeneca's immuno-oncology (IO) portfolio with
pre-clinical and clinical potential new medicines.
AstraZeneca will obtain full oncology rights to the first-in-class
humanised anti-NKG2A antibody, monalizumab, expanding its
partnership with Innate from the initial
collaboration announced in
2015. AstraZeneca also gains
option rights to IPH5201, an antibody targeting CD39, as well as
four preclinical molecules from Innate's pipeline. Innate is
licensing the US and EU commercial rights to recently
FDA-approved Lumoxiti (moxetumomab pasudotox) for hairy cell
leukaemia (HCL).
Pascal Soriot, Chief Executive Officer, said: "Our expanded
collaboration with Innate Pharma enables us to further strengthen
our leadership in immuno-oncology, and to explore the potential of
next-generation immuno-oncology pathways, together with the
world-class scientific team of Innate. Today's agreement also
secures the long-term commercialisation of the recently FDA
approved rare disease medicine, Lumoxiti, through dedicated focus and investment by
Innate Pharma."
Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, said:
"Today is a defining moment for Innate Pharma as we transition to
become a fully-integrated oncology-focused
biotech. Lumoxiti is a major therapeutic innovation for
patients who suffer from relapsed/refractory hairy cell leukaemia,
and we are proud to be in a position to address a significant unmet
medical need. Our commercial team will be focused on rare cancers
and generate more value as our own haemato-oncology proprietary
pipeline develops."
Monalizumab
Building on a 2015
collaboration with Innate,
AstraZeneca is exercising its option to obtain full oncology rights
to monalizumab, a first-in-class humanised anti-NKG2A antibody.
NKG2A is a checkpoint receptor expressed on tumour-infiltrating
cytotoxic T-cells and natural killer (NK) cells that inhibits their
anti-cancer functions. The companies currently share Phase II
development for monalizumab in combination trials in both head and
neck and colorectal cancer, with additional trials underway in
other solid tumours.
Results from a single-arm Phase II trial of monalizumab in
combination with cetuximab in head and neck cancer patients were
presented at the ESMO 2018 Congress (European Society of Medical
Oncology), showing deep and durable responses in 40 patients with
ORR of 27.5%, progression free survival of 5.0 and overall survival
of 10.3 months, respectively. Among the 40 patients enrolled in the
cohort expansion, the safety findings were consistent with
previously-presented data at AACR 2017 and 2018 (Abstract
#1049PD).
CD39 and additional molecules
AstraZeneca is entering into a development collaboration and option
for further co-development and co-commercialisation with Innate for
its CD39 monoclonal antibody, IPH5201.
CD39 is a membrane-bound
extracellular enzyme overexpressed on both regulatory T-cells and
tumour cells in several cancer types. CD39 plays an important role
in promoting immunosuppression through the pathway that degrades
adenosine triphosphate (ATP) into adenosine. It is increasingly recognised that the
adenosine pathway is critical in tumour immunosuppression and will
complement AstraZeneca's current portfolio in this
area.
In addition, Innate grants AstraZeneca an option to exclusively
license four molecules to be agreed upon from Innate's preclinical
portfolio, increasing the breadth and depth of AstraZeneca's
immuno-oncology portfolio.
Lumoxiti
Innate is licensing the US commercial rights of AstraZeneca's
recently FDA-approved treatment for HCL, Lumoxiti.
Innate, with support from AstraZeneca, will continue EU development
and commercialisation, pending regulatory submission and
approval.
Lumoxiti is a CD22-directed cytotoxin and a first-in-class medicine
in the US for adult patients with relapsed or refractory HCL who
have received at least two prior systemic therapies, including
treatment with a purine nucleoside analogue. Approximately 1,000
people are diagnosed with HCL in the US each year, a subset of
which would be eligible for Lumoxiti. Innate will recognise
revenues and co-commercialise Lumoxiti with AstraZeneca in the US
and will take full responsibility by mid-2020.
Financial considerations
Innate will pay AstraZeneca $50 million upfront for Lumoxiti, and
$25 million for future commercial and regulatory milestones, in
consideration for its intellectual property and clinical and
manufacturing development of the medicine. This income will be
recorded as Other Operating Income by AstraZeneca.
AstraZeneca will pay Innate $100 million in the first quarter of
2019 for the expansion of the monalizumab collaboration. Additional
financial arrangements related to monalizumab are detailed and
available in the 2015 collaboration announcement.
Further, AstraZeneca will pay Innate $50 million upfront for the
development collaboration and option for further co-development and
co-commercialisation of Innate's CD39 monoclonal antibody, IPH5201,
plus an option exercise fee, milestones and royalties. Innate will
have the potential for co-promotion and profit sharing in the
EU.
AstraZeneca will also pay Innate $20 million upfront for an
exclusive license option on four to-be-agreed molecules from
Innate's preclinical portfolio. These options can be exercised
before the molecules reach clinical development, triggering an
option exercise fee in addition to milestones and royalties. Innate
will have the potential for co-promotion and profit sharing in the
EU, dependent on future progress.
Given the long-term collaboration between the two companies,
AstraZeneca will acquire a 9.8% equity stake in Innate Pharma
through the issuance of 6,260,500 new shares to AstraZeneca at
€10/share. Issuance of the new shares is expected to take
place on or about 25 October 2018.
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 Oncology as a growth driver for
AstraZeneca 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 MedImmune
MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology, Respiratory, Cardiovascular, Renal & Metabolic
Diseases, and Infection and Vaccines. The MedImmune headquarters is
located in Gaithersburg, MD, one of AstraZeneca's three global
R&D centres, with additional sites in Cambridge, UK and South
San Francisco, CA. For more information, please
visit www.medimmune.com.
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 www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
|
Media Relations
|
|
|
|
|
Karen
Birmingham
|
|
UK/Global
|
+44 203
749 5634
|
|
Rob
Skelding
|
|
UK/Global
|
+44 203
749 5821
|
|
Matt
Kent
|
|
UK/Global
|
+44 203
749 5906
|
|
Gonzalo
Viña
|
|
UK/Global
|
+44 203
749 5916
|
|
Jennifer
Hursit
|
|
UK/Global
|
+44
7384 799726
|
|
Jacob
Lund
|
|
Sweden
|
+46
8 553 260 20
|
|
Michele
Meixell
|
|
US
|
+1 302
885 2677
|
|
Investor Relations
|
|
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203
749 5712
|
|
|
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
|
|
|
Christer
Gruvris
|
Cardiovascular;
Metabolism
|
+44 203
749 5711
|
|
|
|
Nick
Stone
|
Respiratory;
Renal
|
+44 203
749 5716
|
|
|
|
Josie
Afolabi
|
Other
|
+44 203
749 5631
|
|
|
|
Craig
Marks
|
Finance;
Fixed Income
|
+44
7881 615 764
|
|
|
|
Jennifer
Kretzmann
|
Retail
Investors
|
+44 203
749 5824
|
|
|
|
US
toll-free
|
|
+1 866
381 7277
|
|
|
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:
23 October
2018
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|