~Divestiture to Incyte Strengthens Financial
Position
~ ARIAD Receives $140 Million Upfront Payment,
$135 million to be Received in Potential Oncology Milestones,
Tiered Royalty Payments of Between 32% and 50%
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that
it has completed the sale of its European operations to Incyte
Corporation and entered into the previously announced license
agreement for Incyte to exclusively license Iclusig® (ponatinib) in
Europe and other select countries.
ARIAD transferred all rights to its EU operations to Incyte,
which has acquired 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 at the closing of approximately
$140 million (subject to customary post-closing adjustments). In
addition, Incyte has now been granted an exclusive license to
develop and commercialize Iclusig in the European Union and 22
other countries, including Switzerland, Norway, Turkey, Israel and
Russia.
“With the closing of this transaction, we have completed a key
outcome from our strategic review,” stated Paris Panayiotopoulos,
president and chief executive officer of ARIAD. “This agreement
puts ARIAD in a strong financial position. It will allow us to
focus our resources on our promising R&D initiatives and our
efforts to achieve the full commercial potential of Iclusig and
brigatinib, if approved, in the highly valuable U.S. market, while
also maintaining future strategic flexibility through the buy-back
provision for the licensed Iclusig rights.”
In connection with the closing of the Incyte transaction, the
previously disclosed amendments to ARIAD’s royalty financing
agreement with PDL BioPharma, Inc. (PDL), entered into on May 9,
2016, became effective. ARIAD and PDL agreed to amend the agreement
to, among other things, include net sales of Iclusig made by Incyte
in the calculation of net sales under the PDL agreement and to
restructure ARIAD’s option to receive additional funding so that
ARIAD may require PDL to fund up to an additional $40 million
(instead of the original $100 million) in July 2017, rather than
between January and July 2016.
Baker & McKenzie LLP represented ARIAD in the Incyte
transaction, and Mintz, Levin, Cohn, Ferris, Glovsky & Popeo,
P.C. represented ARIAD in the PDL transaction.
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 ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts, 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).
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 the statements made by Mr.
Panayiotopoulos, 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160602005344/en/
ARIAD Pharmaceuticals, Inc.For InvestorsManmeet S. Soni,
617-503-7298Manmeet.soni@ariad.comorFor MediaLiza Heapes,
617-620-4888Liza.heapes@ariad.com
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