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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version on businesswire.com: http://www.businesswire.com/news/home/20150610005096/en/
For ARIAD InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor ARIAD MediaLiza
Heapes, 617-621-2315Liza.heapes@ariad.comorFor Paladin/Endo
International plc Investors/MediaKeri P. Mattox,
484-216-7912orFor Paladin/Endo International plc
InvestorsJonathan Neely, 484-216-6645orFor Paladin/Endo
International plc MediaHeather Zoumas-Lubeski, 484-216-6829
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