- Incyte to Accelerate the Expansion of
its European Organization to Optimize the Potential of Future
Product Launches in Europe
- ARIAD to Receive $140 Million Upfront
Payment, Plus Tiered Royalties on European Sales of Iclusig and
Potential Milestones on Future Indications for Iclusig
Incyte Corporation (Nasdaq:INCY) and ARIAD Pharmaceuticals, Inc.
(Nasdaq:ARIA) today announced the entry into a definitive agreement
for Incyte to acquire ARIAD’s European operations. At the close of
the transaction, the companies will also enter into a license
agreement whereby Incyte will obtain an exclusive license to
develop and commercialize Iclusig® (ponatinib) in Europe and other
select countries.
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The planned acquisition of a fully-integrated and established
pan-European team of 125 employees, including medical, sales and
marketing personnel, will further Incyte’s strategic plan and
accelerate the establishment of its operations in Europe, helping
to optimize clinical development and maximize the potential of
future European launches for Incyte’s portfolio of products in
development.
The agreement to divest its European operations and out-license
Iclusig in Europe will enable ARIAD to focus its promotion of
Iclusig on the highly valuable U.S. market, while strengthening its
financial position and maintaining important optionality through a
potential buy-back provision for the Iclusig license rights in the
event of a change-in-control of ARIAD, as described further
below.
Under the terms of the license agreement, Incyte will receive an
exclusive license to develop and commercialize Iclusig, the only
approved BCR-ABL inhibitor with activity against the T315I
mutation, throughout Europe and in other select countries. Iclusig
is approved in Europe for the treatment of patients with chronic
myeloid leukemia (CML) and Philadelphia-positive (Ph+) acute
lymphoblastic leukemia (ALL) who are resistant to or intolerant of
certain second generation BCR-ABL inhibitors and all patients who
have the T315I mutation.
“The acquisition of ARIAD’s European operations is a unique and
strategic opportunity for Incyte, which will further establish our
medical and commercial footprint in Europe,” said Hervé Hoppenot,
chief executive officer of Incyte. “Adding the ARIAD team’s
experience, talent, resources and relationships to our existing
European organization accelerates our planned global expansion and
leaves us well-positioned to maximize the potential future European
launches from our rich development portfolio.”
“The decision to divest our European operations and out-license
the commercial rights to Iclusig in Europe is one of the key
outcomes of our ongoing strategic review,” stated Paris
Panayiotopoulos, president and chief executive officer of ARIAD.
“We are delighted to have Incyte as a committed partner to continue
Iclusig’s strong revenue growth in Europe, while significantly
strengthening our financial position and maintaining future
strategic optionality with a potential buy-back of Iclusig.”
Terms of the Agreements
Pursuant to the terms of a share purchase agreement (the “SPA”),
Incyte will acquire all shares of ARIAD Pharmaceuticals
(Luxembourg) S.a.r.l., the parent company of ARIAD’s European
subsidiaries responsible for the commercialization of Iclusig in
the licensed territory, for a payment to ARIAD of $140 million that
will be funded by Incyte through available cash on hand.
In addition to the SPA, the parties have agreed to enter into a
license agreement (the “License Agreement”), upon the closing of
the SPA, pursuant to which Incyte will be granted an exclusive
license to develop and commercialize Iclusig in the European Union
and 22 other countries, including Switzerland, Norway, Turkey,
Israel and Russia. ARIAD will be entitled to receive tiered
royalties of between 32 and 50 percent on net sales of Iclusig in
the territory and up to $135 million in potential development and
regulatory milestones for Iclusig in new oncology indications in
the territory. ARIAD may also become eligible to receive additional
milestones for non-oncology indications, if approved, in the
territory. Incyte has also agreed to fund a portion of the ongoing
clinical development of Iclusig in ARIAD’s OPTIC and OPTIC-2L
clinical trials through cost-sharing payments of up to $7 million
in each of 2016 and 2017.
The terms of the License Agreement also include an option for an
acquirer of ARIAD to buy back the rights to Iclusig by repaying the
upfront and milestone payments, plus paying an additional amount
based on Iclusig sales during the previous 12 months and royalties
of 20 to 25 percent on sales for the remaining royalty term. The
buy-back provision cannot be exercised before two years or after
six years from the closing of this transaction, and includes a
transition period of up to one year.
The transaction is expected to close on or about June 1, 2016,
subject to customary closing conditions, and is expected to reduce
ARIAD’s 2017 annual operating expenses by approximately $65
million. The transaction is expected to be earnings accretive for
Incyte in 2018.
Both Incyte and ARIAD expect to file additional disclosure
documents with the Securities and Exchange Commission related to
this transaction.
ARIAD Investor Conference Call Today at 8:30 a.m. EDT
ARIAD will hold a live webcast and conference call regarding the
transaction with Incyte this morning at 8:30 a.m. EDT. The live
webcast can be accessed by visiting the investor relations section
of ARIAD’s website at http://investor.ariad.com. The call can be
accessed by dialing 844-249-9386 (domestic) or 270-823-1534
(international) five minutes prior to the start time and providing
the pass code 7492679. A replay of the call will be available on
the ARIAD website approximately two hours after completion of the
call and will be archived for three weeks.
Incyte Conference Call and Webcast Today at 10:00 a.m.
EDT
Incyte will hold its 2016 first-quarter financial results
conference call and webcast this morning at 10:00 a.m. EDT. To
access the conference call, please dial 877-407-9221 for domestic
callers or 201-689-8597 for international callers. When prompted,
provide the conference identification number, 13628695.
If you are unable to participate, a replay of the conference
call will be available for 30 days. The replay dial-in number for
the United States is 877-660-6853 and the dial-in number for
international callers is 201-612-7415. To access the replay you
will need the conference identification number, 13628695.
The conference call will also be webcast live and can be
accessed at www.incyte.com in the Investors section under “Events
and Presentations”.
About CML and Ph+ ALL
CML is a cancer of the white blood cells that is diagnosed in
approximately 7,000 patients each year
in Europe1. CML is characterized by an excessive and
unregulated production of white blood cells by the bone marrow due
to a genetic abnormality that produces the BCR-ABL protein. After a
chronic phase of production of too many white blood cells, CML
typically evolves to the more aggressive phases referred to as
accelerated phase and blast crisis. Ph+ ALL is a subtype of acute
lymphoblastic leukemia that carries the Ph+ chromosome that
produces BCR-ABL. It has a more aggressive course than CML and is
often treated with a combination of chemotherapy and tyrosine
kinase inhibitors. The BCR-ABL protein is expressed in both of
these diseases.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig
is BCR-ABL, an abnormal tyrosine kinase that is expressed in
chronic myeloid leukemia (CML) and Philadelphia-chromosome positive
acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using
ARIAD’s computational and structure-based drug-design platform
specifically to inhibit the activity of BCR-ABL. Iclusig targets
not only native BCR-ABL but also its isoforms that carry mutations
that confer resistance to treatment, including the T315I mutation,
which has been associated with resistance to other approved
TKIs.
Iclusig is approved in the U.S., EU, Australia, Switzerland,
Israel and Canada.
In the U.S., Iclusig is a kinase inhibitor indicated for
the:
• Treatment of adult patients with T315I-positive
chronic myeloid leukemia (chronic phase, accelerated phase, or
blast phase) or T315I-positive Philadelphia chromosome positive
acute lymphoblastic leukemia (Ph+ ALL).
• Treatment of adult patients with chronic phase,
accelerated phase, or blast phase chronic myeloid leukemia or Ph+
ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is
indicated.
These indications are based upon response rate. There are no
trials verifying an improvement in disease-related symptoms or
increased survival with Iclusig.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED
WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITY
See full prescribing information for complete boxed
warning
• Vascular Occlusion: Arterial and venous thrombosis
and occlusions have occurred in at least 27% of Iclusig treated
patients, including fatal myocardial infarction, stroke, stenosis
of large arterial vessels of the brain, severe peripheral vascular
disease, and the need for urgent revascularization procedures.
Patients with and without cardiovascular risk factors, including
patients less than 50 years old, experienced these events. Monitor
for evidence of thromboembolism and vascular occlusion. Interrupt
or stop Iclusig immediately for vascular occlusion. A benefit risk
consideration should guide a decision to restart Iclusig
therapy.
• Heart Failure, including fatalities, occurred in 8%
of Iclusig-treated patients. Monitor cardiac function. Interrupt or
stop Iclusig for new or worsening heart failure.
• Hepatotoxicity, liver failure and death have
occurred in Iclusig-treated patients. Monitor hepatic function.
Interrupt Iclusig if hepatotoxicity is suspected.
Please see the full U.S. Prescribing Information
for Iclusig, including the Boxed Warning, for additional
important safety information.
In the EU, Iclusig is approved for the treatment of adult
patients with chronic phase, accelerated phase or blast phase
chronic myeloid leukemia (CML) who are resistant to dasatinib or
nilotinib; who are intolerant to dasatinib or nilotinib and for
whom subsequent treatment with imatinib is not clinically
appropriate; or who have the T315I mutation, or the treatment of
adult patients with Philadelphia-chromosome positive acute
lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib;
who are intolerant to dasatinib and for whom subsequent treatment
with imatinib is not clinically appropriate; or who have the T315I
mutation.
Click here to view the Iclusig EU Summary of Medicinal
Product Characteristics. Click here to view the EU
Dear Healthcare Provider Letter (PDF).
About Incyte
Incyte Corporation is a Wilmington, Delaware-based
biopharmaceutical company focused on the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit the Company’s website at
www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an orphan oncology
company focused on transforming the lives of cancer patients with
breakthrough medicines. ARIAD is working on new medicines to
advance the treatment of various forms of chronic and acute
leukemia, lung cancer and other difficult-to-treat orphan cancers.
ARIAD utilizes computational and structural approaches to design
small-molecule drugs that overcome resistance to existing cancer
medicines. For additional information,
visit http://www.ariad.com or follow ARIAD on Twitter
(@ARIADPharm).
Incyte Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release contain predictions,
estimates and other forward-looking statements, including without
limitation statements regarding: whether and when the planned
acquisition of ARIAD’s European operations and of the rights for
Iclusig will close; whether and when this planned acquisition will
effectively advance Incyte’s European organization, maximize any
future European product launches or be accretive to Incyte’s
earnings; and whether and when any of Incyte’s product candidates
will be approved in Europe. These forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially, including unanticipated developments in and
risks related to: obtaining approval for this planned acquisition;
the possibility that results of clinical trials may be unsuccessful
or insufficient to meet applicable regulatory standards or warrant
continued development; other market or economic factors;
unanticipated delays; our ability to compete against parties with
greater financial or other resources; greater than expected
expenses; and such other risks detailed from time to time in
Incyte’s reports filed with the Securities and Exchange Commission,
including our Form 10-K for the year ended December 31, 2015.
Incyte disclaims any intent or obligation to update these
forward-looking statements.
ARIAD Forward-Looking Statements
This press release contains forward-looking
statements, each of which are qualified in their entirety by this
cautionary statement. Any statements contained herein which do not
describe historical facts, including, but not limited to statements
related to the expected completion of the proposed transaction with
Incyte and the closing date of the transaction, the expected
benefits to ARIAD of the proposed transaction with Incyte, the
impact of the transaction on ARIAD’s financial position and
operating expenses, and ARIAD’s plans following the completion of
the transaction, are forward-looking statements that are based on
management’s expectations and are subject to certain factors, risks
and uncertainties that may cause actual results, outcome of events,
timing and performance to differ materially from those expressed or
implied by such statements. These factors, risks and uncertainties
include, but are not limited to, our ongoing strategic review, our
ability to successfully commercialize and generate profits from
sales of Iclusig and our product candidates, if approved;
competition from alternative therapies; our ability to meet
anticipated clinical trial commencement, enrollment and completion
dates and regulatory filing dates for our products and product
candidates and to move new development candidates into the clinic;
our ability to execute on our key corporate initiatives; regulatory
developments and safety issues, including difficulties or delays in
obtaining regulatory and pricing and reimbursement approvals to
market our products; our reliance on the performance of third-party
manufacturers and specialty pharmacies for the supply and
distribution of our products and product candidates; the occurrence
of adverse safety events with our products and product candidates;
the costs associated with our research, development, manufacturing,
commercialization and other activities; the conduct, timing and
results of preclinical and clinical studies of our products and
product candidates, including that preclinical data and early-stage
clinical data may not be replicated in later-stage clinical
studies; the adequacy of our capital resources and the availability
of additional funding; the ability to satisfy our contractual
obligations, including under our leases, convertible debt and
royalty financing agreements; patent protection and third-party
intellectual property claims; litigation; our operations in foreign
countries; risks related to key employees, markets, economic
conditions, health care reform, prices and reimbursement rates; and
other risk factors detailed in our public filings with the U.S.
Securities and Exchange Commission, including our most recent
Annual Report on Form 10-K and subsequent Quarterly Reports on Form
10-Q. Except as otherwise noted, these forward-looking statements
speak only as of the date of this press release and we undertake no
obligation to update or revise any of these statements to reflect
events or circumstances occurring after this press release. We
caution investors not to place considerable reliance on the
forward-looking statements contained in this press release.
1 Rohrbacher M, Hasford J. Epidemiology of chronic myeloid
leukaemia (CML). Best Pract Res Clin Haematol. 2009
Sep;22(3):295-302. Based on current estimate of population of
Europe (738,199,000 in 2010).
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160509005515/en/
For
Incyte:MediaCatalina Loveman,
302-498-6171cloveman@incyte.comorInvestorsMichael Booth,
302-498-5914DPhilmbooth@incyte.comorFor
ARIAD:MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.comorInvestorsMaria Cantor,
617-621-2208Maria.cantor@ariad.com
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