ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) and Paladin Labs Inc., an
operating company of Endo International plc (NASDAQ: ENDP) (TSX: ENL),
today announced that ARIAD has granted Paladin exclusive rights to
distribute Iclusig™ (as ponatinib hydrochloride) in Canada for its newly
approved indications. Paladin is focused on acquiring or in-licensing
innovative pharmaceutical products for the Canadian market.
Health Canada recently approved Iclusig for the treatment of adult
patients with all phases of chronic myeloid leukemia (CML) or
Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
for whom other tyrosine kinase inhibitor (TKI) therapy is not
appropriate, including CML or Ph+ ALL that is T315I mutation positive,
or where there is prior TKI resistance or intolerance. Iclusig will be
made available through a controlled distribution program, whereby
prescribers who have completed the certification procedure will be able
to prescribe Iclusig.
“Paladin has a proven track record of successfully commercializing
innovative pharmaceuticals in Canada and will be a strong partner for
us,” said Marty J. Duvall, executive vice president and chief commercial
officer of ARIAD. “Through this commercial distribution agreement, we
are confident that Iclusig will become available for appropriate
patients with Ph+ leukemias who otherwise would have limited treatment
options available.”
Under the terms of the agreement, ARIAD will continue to be the
Marketing Authorization Holder of Iclusig in Canada, and Paladin will be
responsible for distribution, sales and marketing, medical affairs, and
pricing and reimbursement activities. Paladin will book sales of Iclusig
in Canada while ARIAD will supply packaged drug to Paladin.
“Iclusig has shown promising clinical evidence to address this serious
unmet medical need,” said Mark Beaudet, President of Paladin. “We are
excited to add this important medicine to our core
pharmaceutical-product offering in Canada through our collaboration with
ARIAD.”
CML is a cancer of the white blood cells that according to the Chronic
Myelogenous Leukemia Society of Canada affects 1 in 100,000, with about
5,500 Canadians living with the disease. In 2010, more than 550 people
in Canada were estimated to be diagnosed with CML, and 480 people were
estimated to be diagnosed with ALL.
About Iclusig™ (as ponatinib hydrochloride)
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.
Indications in Canada
ICLUSIG is indicated for the treatment of adult patients with chronic
phase, accelerated phase, or blast phase chronic myeloid leukemia (CML)
or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+
ALL) for whom other tyrosine kinase inhibitor (TKI) therapy is not
appropriate, including CML or Ph+ ALL that is T315I mutation positive or
where there is prior TKI resistance or intolerance.
Marketing authorization with conditions is based on response rate. There
are no trials demonstrating increased survival or improvement in
symptoms with ICLUSIG. In the pivotal trial, the majority of the
hematological responses occurred within 1 month. Consider discontinuing
ICLUSIG if a hematological response has not been achieved by 3 months
(90 days).
ICLUSIG for this indication has been issued marketing authorization
with conditions, pending the results of studies to verify its clinical
benefit. Patients should be advised of the conditional nature of the
authorization.
Contraindications
-
Do not use in patients who are hypersensitive to ponatinib or to any
ingredient in the formulation or component of the container. For a
complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING
section of the Product Monograph.
-
Do not use in patients who have unmanaged cardiovascular risk factors,
including uncontrolled hypertension. Hypertension may contribute to
the risk of arterial thrombotic events. Blood pressure should be
monitored and managed to avoid hypertension.
-
Do not use in patients who are not adequately hydrated and with
uncorrected high uric acid levels.
Serious Warnings and Precautions
ICLUSIG has serious warnings and precautions for: vascular occlusion,
heart failure, hemorrhage, hepatotoxicity, myelosuppression, and
pancreatitis.
ICLUSIG should only be prescribed and monitored by a physician who has
completed the certification with the ICLUSIG Controlled Distribution
Program and who is experienced in the use of antineoplastic therapy and
in the treatment of CML or Ph+ ALL.
-
Vascular Occlusion (arterial and venous thrombosis and occlusions),
occurred in 24% (129/530) of ICLUSIG-treated patients with and without
cardiovascular risk factors (including patients less than 50 years
old). In clinical trials, serious treatment-emergent arterial
thrombosis (cardiovascular, cerebrovascular, and peripheral vascular)
and occlusions were seen in 14% of the ICLUSIG-treated patients
including fatal myocardial infarction, fatal cerebral infarction,
stroke, disseminated intravascular coagulation, and arterial stenosis
sometimes requiring urgent revascularization procedures. Some of these
events occurred within 2 weeks of starting treatment with ICLUSIG.
Monitor for evidence of thromboembolism and vascular occlusion.
Interrupt or consider discontinuation in patients who develop arterial
thrombotic events.
-
Heart Failure (in some cases, fatal), including left ventricular
dysfunction and ejection fraction decreases, occurred in 8% of
ICLUSIG-treated patients, 5% of which were serious.
-
Hemorrhage events (some fatal) including intracranial hemorrhage,
hemorrhagic gastritis, (fatal), hemorrhagic cerebral infarction
(fatal). Most hemorrhagic events, but not all, occurred in patients
with grade 4 thrombocytopenia.
-
Hepatotoxicity (including fatal acute hepatic failure) has been
reported. Monitor hepatic function prior to and during treatment.
Consider ICLUSIG dose interruption followed by dose reduction or
discontinuation in patients with hepatotoxicity.
-
Myelosuppression (thrombocytopenia, neutropenia, and anemia).
-
Pancreatitis (7%) and elevations in amylase (2% grade 3 or greater) or
lipase (12% grade 3 or greater) have been reported.
-
ICLUSIG has not been studied in patients with renal impairment.
Most Common Adverse Reactions
Overall, the very common adverse reactions (≥ 10%) were platelet count
decreased, rash, dry skin, abdominal pain, neutrophil count decreased,
headache, lipase increased, fatigue, constipation, myalgia, arthralgia,
nausea, anemia, ALT increased, hypertension, and AST increased.
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty
pharmaceutical company focused on acquiring or in-licensing innovative
pharmaceutical products for the Canadian market. Paladin has a focused
marketing and sales organization that has helped it evolve into one of
Canada's leading specialty pharmaceutical companies. Paladin is an
operating company of Endo International plc (NASDAQ: ENDP) (TSX: ENL), a
global specialty pharmaceutical company focused on improving patients'
lives while creating shareholder value. Learn more at www.endo.com
or www.paladin-labs.com.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts
and Lausanne, Switzerland, is an integrated global 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 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).
Iclusig® is a registered trademark of ARIAD Pharmaceuticals,
Inc. in the U.S. and is trademarked in Canada.
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 regarding: ARIAD’s partnership
with Paladin and the therapeutic potential of Iclusig, 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
ARIAD’s ability to manufacture and supply Iclusig to Paladin; the
ability of Paladin to perform the contracted services and to obtain
pricing and reimbursement approval for Iclusig in Canada, including as a
result of regulatory developments and the level of any such pricing and
reimbursement approvals; safety issues related to Iclusig; Paladin’s
ability to successfully distribute, market, promote and sell Iclusig in
Canada; the timing and scope of any additional marketing authorizations
for Iclusig in Canada; third-party reimbursement; the timing and success
of sales of Iclusig in Canada; the costs associated with ARIAD’s
development and manufacturing, commercial and other activities; the
adequacy of ARIAD’s capital resources and the availability of additional
funding; and those additional factors detailed in ARIAD’s 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.
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