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2018-10-23

AstraZeneca: 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
(https://www.astrazeneca.com/media-centre/press-releases/2015/astrazeneca...).
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
(https://www.astrazeneca.com/media-centre/press-releases/2015/astrazeneca...)
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
(https://www.astrazeneca.com/media-centre/press-releases/2018/us-fda-appr...).
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 26
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
(http://s.bl-1.com/h/ch6zqQpo?url=https://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.

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