- Innate Pharma acquires US and EU rights to commercialize
Lumoxiti to become a fully-integrated oncology-focused
biotech
- AstraZeneca obtains full oncology rights to
monalizumab
- AstraZeneca gains access to Innate Pharma's anti-CD39
monoclonal antibody, IPH5201, plus four additional immuno-oncology
molecules
- AstraZeneca to purchase newly-issued equity stake of 9.8% in
Innate Pharma
Marseille, France, October 23, 2018, 7:00 AM
CEST
Innate Pharma SA ("Innate" - Euronext Paris:
FR0010331421 - IPH), today announced a new multi-term agreement
with AstraZeneca, and its global biologics research and development
arm MedImmune, 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
enable Innate to develop its commercial footprint and strengthen
its ability to invest in its immuno-oncology (IO) pipeline and
R&D platform and will also enrich AstraZeneca's IO portfolio
with preclinical and clinical potential new medicines.
Under the terms of the agreement, Innate is
licensing the US and EU commercial rights to AstraZeneca's recently
FDA-approved Lumoxiti (moxetumomab pasudotox-tdfk) for hairy cell
leukemia ("HCL"). 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
pre-clinical molecules from Innate's pipeline.
Mondher Mahjoubi, Chief Executive Officer of
Innate Pharma, said: "Today is a defining moment for Innate 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 leukemia 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 hemato-oncology proprietary pipeline develops.
Furthermore, AstraZeneca's decision to obtain full oncology rights
to monalizumab and collaborate on IPH5201 and four yet to be
selected molecules validates the strength of our oncology
pipeline."
Pascal Soriot, Chief Executive Officer of
AstraZeneca, 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 long-term commercialization of the
recently FDA approved rare disease medicine, Lumoxiti, through
dedicated focus and investment by Innate."
Lumoxiti:
Innate is licensing the US commercial rights of
AstraZeneca's recently FDA approved medicine for HCL, Lumoxiti,
marking the first step of Innate's strategy to become a fully
integrated company. In addition, Lumoxiti's commercial platform
could be leveraged in the future for Innate's proprietary fully
owned pipeline in haematology including, IPH4102. Innate, with
support from AstraZeneca, will continue EU development and
commercialization, 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 analog.
Approximately 1,000 people are diagnosed with HCL in the US each
year, a subset of which would be eligible for Lumoxiti. Lumoxiti
was approved by the US FDA on 13 September 2018.
Innate will recognize revenues and
co-commercialize Lumoxiti with AstraZeneca in the US and will take
full responsibility by mid-2020. 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.
Monalizumab:
Building on the 2015 collaboration with Innate,
AstraZeneca is exercising its option to obtain full oncology rights
to monalizumab, a first-in-class humanized anti-NKG2A antibody.
NKG2A is a checkpoint receptor expressed on tumor 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 studies in both head and
neck and colorectal cancer, with additional studies underway in
other solid tumors.
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%, PFS of 5.0 and OS 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).
AstraZeneca will pay Innate $100 million in the
first quarter of 2019 for the expansion of the monalizumab
collaboration. As previously announced in the original
collaboration agreement from 2015, $100 million is due at the
potential start of Phase III development.
CD39 and additional preclinical
molecules:
AstraZeneca is entering into a development
collaboration and option for further co-development and
co-commercialization with Innate for its CD39 monoclonal antibody,
IPH5201.
CD39 is a membrane-bound extracellular enzyme
overexpressed on both regulatory T cells and tumor 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 recognized
that the adenosine pathway is critical in tumor immunosuppression
and will complement AstraZeneca's current portfolio in this
area.
AstraZeneca will pay Innate $50 million upfront
plus an option exercise fee, milestones, and royalties. Innate will
have the potential for co-promotion and profit sharing in the
EU.
In addition, Innate grants AstraZeneca an option
to exclusively license four to be-agreed upon molecules from
Innate's preclinical portfolio, increasing the breadth and depth of
AstraZeneca's immuno-oncology portfolio.
AstraZeneca will also pay Innate $20 million
upfront for an exclusive license option on four to be-agreed upon
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.
Equity Investment:
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. The new shares will be issued pursuant to
the 26th resolution of Innate Pharma's May 29, 2018 shareholders'
meeting. Issuance of the new shares is expected to take place on or
about 25th October 2018.
Further details:
Further details on the financial terms of the
agreements can be found here.
Evercore is acting as financial advisor to
Innate Pharma.
Media conference call at 1pm CEST
today:
Innate Pharma will host a conference call for
journalists today at 1pm CEST today to discuss this announcement.
Dial-in details are available from Harpreet Virdi at Consilium
Strategic Communications on email: virdi@consilium-comms.com.
Webcast and conference call for analysts at 2
pm CEST today:
Innate Pharma will host a live webcast and
conference call with a Q&A session for analysts and investors
at 2pm CEST today to discuss this announcement.
The presentation and access to the live webcast
will be available on Innate Pharma's website at
www.innate-pharma.com
Location |
Purpose |
Phone Number |
France |
Participant |
+33 (0)1 76 77 22 57 |
United Kingdom |
Participant |
+44 (0)330 336 9411 |
United States |
Participant |
+1 929-477-0324 |
Standard international access |
Participant |
0800 279 7204 |
The participation code is: 6524843
An audio replay file will be made available
after the session via Innate Pharma's website:
www.innate-pharma.com.
***
About Hairy Cell Leukemia:
Hairy cell leukemia (HCL) is a rare, chronic,
and slow-growing leukemia in which the bone marrow overproduces
abnormal B cell lymphocytes. HCL can result in serious conditions,
including infections, bleeding and anemia. Approximately 1,000
people are diagnosed with HCL in the US each year. HCL accounts for
up to 3% of all adult leukemias. While many patients initially
respond to treatment, 30% to 40% will relapse five to ten years
after their first treatment. With no established standard of care
and very few treatments available, there remains significant unmet
medical need for people with relapsed or refractory HCL.
About Lumoxiti:
LUMOXITI(TM) (moxetumomab pasudotox-tdfk) is a
CD22-directed cytotoxin and a first-in-class treatment in the US
for adult patients with relapsed or refractory hairy cell leukemia
(HCL) who have received at least two prior systemic therapies,
including treatment with a purine nucleoside analog. LUMOXITI is
not recommended in patients with severe renal impairment (CrCl
inferior or egual to 29 mL/min). It comprises the CD22 binding
portion of an antibody fused to a truncated bacterial toxin; the
toxin inhibits protein synthesis and ultimately triggers apoptotic
cell death. LUMOXITI has been granted Orphan Drug Designation by
the FDA for the treatment of HCL.
About the '1053' Phase III Trial:
The '1053' trial is a single-arm, multicenter
Phase III clinical trial assessing the efficacy, safety,
immunogenicity and pharmacokinetics of moxetumomab pasudotox
monotherapy in patients with relapsed or refractory HCL who have
received at least two prior therapies, including one purine
nucleoside analog. The trial was conducted in 80 patients across 34
sites in 14 countries. The primary endpoint was durable complete
response (CR), defined as CR with hematologic remission (blood
count normalization) for >180 days. Secondary outcome measures
included overall response rate, relapse free survival,
progression-free survival, time to response, safety,
pharmacokinetic and immunogenic potential.
About Innate Pharma:
Innate Pharma S.A. is a fully integrated
oncology-focused biotech company dedicated to improving treatment
and clinical outcomes for patients through therapeutic antibodies
that harness the immune system to fight cancer.
Innate Pharma's commercial-stage product,
Lumoxiti, in-licensed from AstraZeneca, was approved by the FDA in
September 2018. Lumoxiti is a first-in class specialty oncology
product for hairy cell leukemia (HCL). Innate Pharma's broad
pipeline of antibodies includes several first-in-class clinical and
preclinical candidates in cancers with high unmet medical need.
Innate Pharma has pioneered the discovery and
development of checkpoint inhibitors, with a unique expertise and
understanding of Natural Killer cell biology. This innovative
approach has resulted in major alliances with leaders in the
biopharmaceutical industry including Bristol-Myers Squibb, Novo
Nordisk A/S, Sanofi, and a landmark and multi-products partnership
with AstraZeneca/Medimmune.
Based in Marseille, France, Innate Pharma is
listed on Euronext Paris.
Learn more about Innate Pharma at
www.innate-pharma.com
Information about Innate Pharma
shares:
ISIN
codeTicker codeLEI |
FR0010331421IPH9695002Y8420ZB8HJE29 |
Disclaimer:
This press release contains certain
forward-looking statements. Although the company believes its
expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those anticipated. For a discussion of risks and
uncertainties which could cause the company's actual results,
financial condition, performance or achievements to differ from
those contained in the forward-looking statements, please refer to
the Risk Factors ("Facteurs de Risque") section of the Document de
Reference prospectus filed with the AMF, which is available on the
AMF website (http://www.amf-france.org) or on Innate Pharma's
website.
This press release and the information contained
herein do not constitute an offer to sell or a solicitation of an
offer to buy or subscribe to shares in Innate Pharma in any
country.
Evercore Partners:
Evercore Partners International LLP
("Evercore"), which is authorised and regulated in the United
Kingdom by the FCA, is acting as financial adviser exclusively for
Innate Pharma and no one else in connection with the Acquisition
and accordingly will not be responsible to anyone other than Innate
Pharma in providing the protections afforded to clients of Evercore
nor for providing advice in relation to the Acquisition, the
content of this Announcement or any matter referred to herein.
Neither Evercore nor any of its subsidiaries, branches or
affiliates owes or accepts any duty, liability or responsibility
whatsoever (whether direct or indirect, whether in contract, in
tort, under statue or otherwise) to any person who is not a client
of Evercore in connection with this Announcement, any statement
contained herein or otherwise.
For additional information, please
contact:
Investors Innate Pharma Dr Markus
Metzger / Danielle Spangler /Jérôme Marino Tel.: +33 (0)4 30 30 30
30 investors@innate-pharma.com |
International Media Consilium Strategic
Communications Mary-Jane Elliott / Jessica Hodgson Tel.: +44
(0)20 3709 5700 InnatePharma@consilium-comms.com |
|
French Media ATCG Press Marie Puvieux
Mob: +33 (0)6 10 54 36 72 presse@atcg-partners.com
|
***
TRANSACTION FACT SHEET
Highlights For Innate Pharma:
- Innate Pharma ("Innate" or the "company") to acquire US and EU
rights to commercialize recently FDA approved Lumoxiti to become a
fully-integrated oncology-focused biotech
- Based on promising data presented at ESMO 2018, AstraZeneca
will exercise its option to gain full rights to monalizumab in
oncology with $100m payment
- Expanding on the successful collaboration, AstraZeneca gains
options to several promising preclinical immuno-oncology molecules,
including IPH5201 (CD39), with $70m combined upfront payment,
validating Innate's core leadership in immuno-oncology discovery
whilst retaining meaningful economic exposure
- Establishment of commercial presence for Lumoxiti is the first
step of building a rare heam-oncology franchise, complementary with
wholly owned pipeline candidate IPH4102
- AstraZeneca to take a 9.8% equity stake in Innate at €10 /
share through the issuance of new shares to AstraZeneca
- Combination of transactions will strengthen Innate's ability to
sustainably invest in its leading pipeline and platform in innate
immunity
- The transaction enables the leveraging of each parties'
strengths, with Innate benefiting from AstraZeneca's development
and product commercialization expertise and AstraZeneca leveraging
Innate's world class R&D capabilities
Lumoxiti Overview:
- Lumoxiti is a recently FDA-approved medicine with orphan drug
designation by the FDA for the treatment of adult patients with
relapsed or refractory Hairy Cell Leukemia ("HCL") who have
received at least two prior systemic therapies, including one
purine nucleoside analog
- Approximately 1,000 people are diagnosed with HCL in the US
each year, and it is estimated that over a third of patients who
suffer from HCL would over the course of the disease be eligible
for Lumoxiti treatment under the current label
- AstraZeneca has announced Lumoxiti will cost $25,000 per cycle,
with treatment of six cycles according to the FDA label
Transaction Terms[1]:
Lumoxiti
- Innate to receive full commercial rights in US & EU
(pending EU submission & approval)
- Innate will pay AstraZeneca $50m upfront as well as future
payments of up to $25m for future commercial and regulatory
milestones contingent on revenue targets and regulatory events
- Innate and AstraZeneca will have a collaborative and staged
transition of operations for the product, with AstraZeneca
responsible for all aspects of the commercialization of Lumoxiti in
the US up to mid-2020 at the latest, with a potential sooner
transition. Innate will reimburse AstraZeneca for costs incurred
other than in 2019 where there will be some sharing of costs
Monalizumab
- Following the promising clinical data presented on monalizumab
at ESMO 2018 and under the initial collaboration announced in 2015,
AstraZeneca obtains the full oncology rights to monalizumab,
Innate's potential first-in-class anti-NKG2A antibody
- Under the terms of the agreement, AstraZeneca will pay Innate
$100m for monalizumab, exercising its option to gain exclusive
rights to co-develop and commercialize monalizumab. Innate is
eligible to a further $100m at the start of the first Ph-III
development and up to an additional $825m for development,
regulatory and commercial related milestones. The joint Ph-II and
Ph-III clinical trials will allocate 70% of development cost to
AstraZeneca and 30% to Innate, with pre-agreed limitation of Innate
financial commitment.
- AstraZeneca will book all sales for monalizumab and will pay
Innate double-digit royalties on net sales upon commercialization.
If Innate elects to co-fund (see above), the agreement includes the
right for Innate to get to co-promote in Europe and a 50% profit
share in the territory
IPH5201 (CD39)
- AstraZeneca will pay Innate a $50m upfront payment for the
option to the exclusive license to co-develop and co-commercialize
IPH5201 and up to $835m in opt-in payments, development and
commercial milestones and high-single to double-digit tiered
royalties
- AstraZeneca may exercise the option before Ph-III trial
start
- AstraZeneca will take all the development costs up to Ph-III
studies. Innate retains the right to participate in cost sharing
for Ph-III to receive 50% profit sharing within the EU
Additional Preclinical Molecules
- AstraZeneca will pay Innate a $20m upfront fee for the option
to gain access to four to be-agreed upon preclinical molecules and
up to $855m per target in opt-in payments, development and
commercial milestones and high-single to double-digit tiered
royalties
- After opt-in and up to Ph-III, AstraZeneca will incur all the
development costs. Innate retains the right to participate in cost
sharing for Ph-III to get 50% profit sharing within the EU
Equity Investment
- AstraZeneca will acquire a 9.8% equity position in Innate
through the issuance of 6,260,500 new shares to AstraZeneca at
€10/share
- The new shares will be issued pursuant to the 26th resolution
of Innate's May 29, 2018 shareholders' meeting. Issuance of the new
shares is expected to take place on or about 25th October 2018
- AstraZeneca has agreed to a 180 days lock-up on the newly
issued shares, subject to customary exceptions (transfers to
affiliates, a tender offer or an Innate approved block trade).
Following this initial 180 days period, and for an additional 180
days, AstraZeneca has agreed to sell its shares only through
orderly market transactions or through marketed block trades. Astra
Zeneca has also agreed to a five year standstill (which can be
waived by Innate), except to the extent necessary to maintain its
stake or if a third party acquires or increases its stake beyond
certain thresholds or launches a tender offer on Innate
Expected Proceeds Timing:
2018 Proceeds
- Innate receives at least $118m from AstraZeneca in 2018
consisting of:
- $72m proceeds from the equity investment
- $26m proceeds from the IPH5201 upfront payment
- $20m proceeds from the Additional Preclinical Molecules upfront
payment
2019 Proceeds
- Innate will receive proceeds of at least $124m from the
transaction (excluding potential additional contingent payments),
including:
- $100m proceeds from the Monalizumab payment
- $24m proceeds from the IPH5201 upfront payment
- Innate will pay at least $50m to AstraZeneca for the Lumoxiti
upfront payment in 2019 with additional contingent payments
potentially payable
Summary of Financial Terms attached to each
partnered asset over the collaboration[2]:
From AstraZeneca to Innate |
From Innate to AstraZeneca |
Monalizumab |
IPH5201 |
Additional 4 Preclinical Molecules |
Lumoxiti |
Opt-in Payment: $100m Next Milestone:
$100m, paid at the initiation of Ph-III trials Other Development
& Regulatory Milestones: Up to $400m
Commercial Milestones: Up to $425m Royalties:
Double digit tiered Co-promotion scheme:Innate
retains the right to participate in profit sharing scheme within
the EU in exchange for co-funding Ph-III development
|
Upfront Payment: $50m Near Term and Opt-in Future
Payments: $35m Further Development & Regulatory
Milestones: Up to $300m Commercial
Milestones: Up to $500m Royalties:
High single digit - double digit tiered Other
Information: AstraZeneca to take charge of development
costs up to Ph-III Co-promotion scheme: Same as
monalizumab |
Upfront Payment: $20m (for all targets) Opt-in Future
Payments: $35m per target Further Development
& Regulatory Milestones: Up to $320m per target
Commercial Milestones: Same as IPH5201 per target
Royalties: Same as IPH5201 Other
Information: After opt-in and up to Ph-III, AstraZeneca will
take all the development costs Co-promotion scheme:
Same as monalizumab |
Upfront Payment: $50m Near Term
Payments: $10m based on 2019 US sales $15m at EU
regulatory submission |
Disclaimer:
This factsheet contains certain forward-looking
statements. Although the company believes its expectations are
based on reasonable assumptions, these forward-looking statements
are subject to numerous risks and uncertainties, which could cause
actual results to differ materially from those anticipated. For a
discussion of risks and uncertainties which could cause the
company's actual results, financial condition, performance or
achievements to differ from those contained in the forward-looking
statements, please refer to the Risk Factors ("Facteurs de Risque")
section of the Document de Reference prospectus filed with the AMF,
which is available on the AMF website (http://www.amf-france.org)
or on Innate Pharma's website.
This factsheet and the information contained
herein do not constitute an offer to sell or a solicitation of an
offer to buy or subscribe to shares in Innate Pharma in any
country.
[1] Refer to "Expected Proceeds Timing" section
for staging of payments
[2] Refer to "Expected Proceeds Timing" section
for staging of payments
- Innate Pharma strengthens and expands collaboration pour
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