- Full approval granted through
completion of accelerated approval commitments for rare cancer
patients who may have no other targeted treatment options
- New label update for CP-CML reflects 55
percent major cytogenetic response rate (MCyR), and 39 percent
major molecular response rate (MMR), a key secondary endpoint
deeper than cytogenetic response
- Safety and efficacy profile updated
based on 48-month follow-up
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that
the U.S. Food and Drug Administration (FDA) has granted Iclusig®
(ponatinib) full approval 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 no other tyrosine kinase
inhibitor (TKI) therapy is indicated; and for the treatment of
adult patients with T315I-positive CML (chronic phase, accelerated
phase, or blast phase) or T315I positive Ph+ ALL. Iclusig was
initially approved in December 2012 under the FDA’s accelerated
approval program, which provides patients earlier access to
promising new drugs that treat serious conditions based on a
surrogate endpoint while the company conducts additional studies to
confirm the drug’s clinical benefit. The therapy was granted the
FDA’s orphan drug designation because it is intended to treat a
rare disease or condition.
This full approval and label update is based on 48-month
follow-up data (as of August 2015) from the pivotal Phase 2 PACE
clinical trial of Iclusig in heavily pretreated patients with
resistant or intolerant CML or Ph+ ALL. These data were presented
at the 2016 meetings of the American Society for Clinical Oncology
and the European Hematology Association (EHA).
“The data on Iclusig continue to show that with a minimum
follow-up of 48 months, many chronic phase CML patients in the PACE
trial have retained long-term cytogenetic and molecular responses,”
stated Timothy P. Clackson, Ph.D., president of research and
development and chief scientific officer at ARIAD. “We are pleased
to have received full approval of this medicine that was discovered
and developed by ARIAD scientists to address rare cancers for
patients who may have no other targeted treatment option. With this
label update we are also now able to communicate to physicians that
patients have experienced deep responses on Iclusig, measured by
major molecular response (MMR). We are continuing our efforts to
understand the optimal Iclusig dose for patients with the OPTIC
(Optimizing Ponatinib Treatment In
CML) post-marketing study.”
“The longer follow up of the PACE study confirms the clinical
benefit of ponatinib in this setting. We had learned from the
initial report of the high response rate with ponatinib among CML
patients with resistance or intolerance to prior therapies. The
four-year follow-up and updated safety profile demonstrate
durability of responses in this heavily pre-treated population.
These results solidify ponatinib as an important and valuable
treatment option for refractory patients with CML where no other
TKI therapy is appropriate, including those who have the T315I
mutation,” stated Jorge Cortes, M.D., professor and deputy chair,
Department of Leukemia, The University of Texas MD Anderson Cancer
Center, and a leading investigator in the PACE trial.
“Prior to the approval of Iclusig, there were patients with CML
for whom no targeted treatment was available, either because they
had developed resistance mutations or intolerance to other approved
treatments. For these patients, we now have a better understanding
of the long-term treatment profile of Iclusig,” stated Greg
Stephens, executive director of the National CML Society. “We have
been impressed by the major molecular responses some patients have
been able to achieve on Iclusig and by ARIAD’s commitment to
supporting patient and caregiver needs.”
Four-Year PACE Trial Data Included in Labeling Update
The efficacy and safety of ponatinib in CML and Ph+ ALL patients
resistant or intolerant to dasatinib or nilotinib, or with the
T315I mutation, were evaluated in the PACE trial. A total of 449
patients were treated with ponatinib at a starting dose of 45
mg/day. An estimated 93 percent of patients previously received two
or more approved tyrosine kinase inhibitors (TKIs), and 56 percent
of all patients had received three or more approved TKIs.
Enrollment in the PACE trial was completed in October 2011.
Updated data on CP-CML patients (n=270) from the ongoing trial
indicate that with a minimum follow-up of 48 months (data as of
August 3, 2015), 110 patients continued to receive ponatinib.
Additional data for CP-CML patients include:
- 55 percent of CP-CML patients achieved
major cytogenetic response (MCyR) (primary endpoint) at any time.
- The median duration of MCyR (range 2.7
to 50+ months) has not been reached.
- 39 percent of patients achieved a major
molecular response (MMR) at any time.
- The median duration of MMR (range 1.7
to 50+ months) has not been reached.
- With four years of follow-up, 33
percent (150/449) of all patients experienced arterial occlusive
events (AOE). Twenty-one percent of patients experienced cardiac
vascular, 12 percent experienced peripheral vascular and 9 percent
experienced cerebrovascular arterial occlusive events, with some
patients experiencing more than one type of AOE. Twenty-two percent
experienced arterial occlusive serious adverse reactions (12%
cardiac vascular, 8% peripheral vascular and 7%
cerebrovascular).
- Six percent of all patients experienced
a venous thromboembolic event.
- The most common any-grade
treatment-emergent adverse events occurring in ≥ 20 percent of
CP-CML patients included hypertension (69%), rash (63%), abdominal
pain (48%), fatigue (47%), headache (43%), arterial ischemia (42%),
dry skin (42%), constipation (41%), arthralgia (32%), nausea (28%),
pyrexia (26%), peripheral neuropathy (24%), myalgia (24%), pain in
extremity (23%), back pain (21%), diarrhea (20%). Post-marketing
cases of reversible posterior leukoencephalopathy syndrome have
been reported.
OPTIC Post-Marketing Trial
ARIAD is currently enrolling patients in the OPTIC
post-marketing trial of Iclusig (ponatinib) which is expected to
inform the optimal dosing of Iclusig. This randomized, dose-ranging
trial is enrolling patients with CP-CML who are resistant to at
least two approved TKIs. Patients are randomized equally to receive
once-daily administration of 45 mg (cohort A), 30 mg (cohort B) or
15 mg (cohort C) of ponatinib. Patients in cohorts A and B will
have their daily dose reduced to 15 mg upon achievement of MCyR.
The primary endpoint of the trial is MCyR by 12 months for each
cohort. ARIAD expects initial data from the OPTIC trial to be
submitted to the American Society of Hematology (ASH) meeting in
2017.
About Iclusig® (ponatinib)
tabletsIclusig 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, Canada and Japan.
In the U.S., Iclusig is a kinase inhibitor 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 no other tyrosine kinase
inhibitor (TKI) therapy is indicated.
- Treatment of adult patients with
T315I-positive chronic myeloid leukemia (chronic phase, accelerated
phase, or blast phase) or T315I-positive Ph+ ALL.
Limitations of use:
Limitations of use: Iclusig is not indicated and is not
recommended for the treatment of patients with newly diagnosed
chronic phase CML.
IMPORTANT SAFETY INFORMATIONBased on the Phase 2 48 mo.
follow-up analysis (N=449), except where noted
IMPORTANT U.S. SAFETY INFORMATION, INCLUDING THE BOXED
WARNINGWARNING: ARTERIAL OCCLUSION, VENOUS THROMBOEMBOLISM,
HEART FAILURE, and HEPATOTOXICITY
See full prescribing information for complete boxed
warning.
- Arterial occlusion has occurred in
at least 35% of Iclusig® (ponatinib)-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. Interrupt or stop
Iclusig immediately for arterial occlusion. A benefit-risk
consideration should guide a decision to restart Iclusig.
- Venous Thromboembolism has occurred
in 6% of Iclusig-treated patients. Monitor for evidence of
thromboembolism. Consider dose modification or discontinuation of
Iclusig in patients who develop serious venous
thromboembolism.
- Heart Failure, including fatalities
occurred in 9% 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.
Warnings and Precautions
Arterial Occlusions: Arterial occlusions, including fatal
myocardial infarction, stroke, stenosis of large arterial vessels
of the brain, severe peripheral vascular disease have occurred in
at least 35% of Iclusig-treated patients from the phase 1 and phase
2 trials. In the phase 2 trial, 33% (150/449) of Iclusig-treated
patients experienced a cardiac vascular (21%), peripheral vascular
(12%), or cerebrovascular (9%) arterial occlusive event; some
patients experienced more than 1 type of event. Fatal and
life-threatening events have occurred within 2 weeks of starting
treatment, with doses as low as 15 mg per day. Iclusig can also
cause recurrent or multi-site vascular occlusion. Patients have
required revascularization procedures. The median time to onset of
the first cardiac vascular, cerebrovascular, and peripheral
vascular arterial occlusive events was 193, 526, and 478 days,
respectively. Patients with and without cardiovascular risk
factors, some age 50 years or younger, experienced these events.
The most common risk factors observed with these events were
hypertension, hyperlipidemia, and history of cardiac disease.
Arterial occlusive events were more frequent with increasing age
and in patients with a history of ischemia, hypertension, diabetes,
or hyperlipidemia. In patients suspected of developing arterial
occlusive events, interrupt or stop Iclusig.
Venous Thromboembolism: Venous thromboembolic events
occurred in 6% (25/449) of Iclusig-treated patients with an
incidence rate of 5% (13/270 CP-CML), 4% (3/85 AP-CML), 10% (6/62
BP-CML) and 9% (3/32 Ph+ ALL). Events included: deep venous
thrombosis, pulmonary embolism, superficial thrombophlebitis, and
retinal vein thrombosis with vision loss. Consider dose
modification or discontinuation of Iclusig in patients who develop
serious venous thromboembolism.
Heart Failure: Fatal or serious heart failure or left
ventricular dysfunction occurred in 6% of Iclusig-treated patients
(29/449). Nine percent of patients (39/449) experienced any grade
of heart failure or left ventricular dysfunction. The most
frequently reported heart failure events were congestive cardiac
failure and decreased ejection fraction (14 patients each; 3%).
Monitor patients for signs or symptoms consistent with heart
failure and treat as clinically indicated, including interruption
of Iclusig. Consider discontinuation if serious heart failure
develops.
Hepatotoxicity: Iclusig can cause hepatotoxicity,
including liver failure and death. Fulminant hepatic failure
leading to death occurred in a patient within one week of starting
Iclusig. Two additional fatal cases of acute liver failure also
occurred. The fatal cases occurred in patients with BP-CML or Ph+
ALL. Severe hepatotoxicity occurred in all disease cohorts, with
11% (50/449) experiencing grade 3 or 4 hepatotoxicity. The most
common forms of hepatotoxicity were elevations of AST or ALT (54%
all grades, 8% grade 3 or 4, 5% not reversed at last follow-up),
bilirubin, and alkaline phosphatase. Hepatotoxic events were
observed in 29% of patients. The median time to onset of
hepatotoxicity event was 3 months. Monitor liver function
tests at baseline, then at least monthly or as clinically
indicated. Interrupt, reduce or discontinue Iclusig as clinically
indicated.
Hypertension: Treatment-emergent elevation of systolic or
diastolic blood pressure (BP) occurred in 68% (306/449) of
Iclusig-treated patients. Fifty-three patients (12%) experienced
treatment-emergent symptomatic hypertension as a serious adverse
reaction, including hypertensive crisis. Patients may require
urgent clinical intervention for hypertension associated with
confusion, headache, chest pain, or shortness of breath. In
patients with baseline systolic BP<140 mm Hg and baseline
diastolic BP<90 mm Hg, 80% (229/285) experienced
treatment-emergent hypertension; 44% (124/285) developed Stage 1
hypertension, 37% developed Stage 2 hypertension. In 132 patients
with Stage 1 hypertension at baseline, 67% (88/132) developed Stage
2 hypertension. Monitor and manage blood pressure elevations during
Iclusig use and treat hypertension to normalize blood pressure.
Interrupt, dose reduce, or stop Iclusig if hypertension is not
medically controlled. In the event of significant worsening, labile
or treatment-resistant hypertension, interrupt treatment and
consider evaluating for renal artery stenosis.
Pancreatitis: Pancreatitis occurred in 7% (31/449, 6%
serious or grade 3/4) of Iclusig-treated patients. The incidence of
treatment-emergent lipase elevation was 42% (16% grade 3 or
greater). Pancreatitis resulted in discontinuation or treatment
interruption in 6% of patients (26/449). The median time to onset
of pancreatitis was 14 days. Twenty-three of the 31 cases of
pancreatitis resolved within 2 weeks with dose interruption or
reduction. Check serum lipase every 2 weeks for the first 2 months
and then monthly thereafter or as clinically indicated. Consider
additional serum lipase monitoring in patients with a history of
pancreatitis or alcohol abuse. Dose interruption or reduction may
be required. In cases where lipase elevations are accompanied by
abdominal symptoms, interrupt treatment with Iclusig and evaluate
patients for pancreatitis. Do not consider restarting Iclusig until
patients have complete resolution of symptoms and lipase levels are
less than 1.5 x ULN.
Increased Toxicity in Newly Diagnosed Chronic Phase CML:
In a prospective randomized clinical trial in the first-line
treatment of newly diagnosed patients with chronic phase (CP) CML,
single agent Iclusig 45 mg once-daily increased the risk of serious
adverse reactions 2-fold compared to single agent imatinib 400 mg
once-daily. The median exposure to treatment was less than 6
months. The trial was halted for safety in October 2013. Arterial
and venous thrombosis and occlusions occurred at least twice as
frequently in the Iclusig arm compared to the imatinib arm.
Compared to imatinib-treated patients, Iclusig-treated patients
exhibited a greater incidence of myelosuppression, pancreatitis,
hepatotoxicity, cardiac failure, hypertension, and skin and
subcutaneous tissue disorders. Iclusig is not indicated and is not
recommended for the treatment of patients with newly diagnosed
CP-CML.
Neuropathy: Peripheral and cranial neuropathy have
occurred in Iclusig-treated patients. Overall, 20% (90/449) of
Iclusig-treated patients experienced a peripheral neuropathy event
of any grade (2%, grade 3/4). The most common peripheral
neuropathies reported were paresthesia (5%, 23/449), neuropathy
peripheral (4%, 19/449), hypoesthesia (3%, 15/449), dysgeusia (2%,
10/449), muscular weakness (2% 10/449) and hyperesthesia (1%,
5/449). Cranial neuropathy developed in 2% (10/449) of
Iclusig-treated patients (<1%, 3/449 - grade 3/4). Of the
patients who developed neuropathy, 26% (23/90) developed neuropathy
during the first month of treatment. Monitor patients for symptoms
of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia,
discomfort, a burning sensation, neuropathic pain or weakness.
Consider interrupting Iclusig and evaluate if neuropathy is
suspected.
Ocular Toxicity: Serious ocular toxicities leading to
blindness or blurred vision have occurred in Iclusig-treated
patients. Retinal toxicities including macular edema, retinal vein
occlusion, and retinal hemorrhage occurred in 2% of Iclusig-treated
patients. Conjunctival irritation, corneal erosion or abrasion, dry
eye, conjunctivitis, conjunctival hemorrhage, hyperaemia and edema
or eye pain occurred in 14% of patients. Visual blurring occurred
in 6% of patients. Other ocular toxicities include cataracts,
periorbital edema, blepharitis, glaucoma, eyelid edema, ocular
hyperaemia, iritis, iridocyclitis, and ulcerative keratitis.
Conduct comprehensive eye exams at baseline and periodically during
treatment.
Hemorrhage: Serious hemorrhage events including
fatalities, occurred in 6% (28/449) of patients treated with
Iclusig. Hemorrhage occurred in 28% (124/449) of patients. The
incidence of serious bleeding events was higher in patients with
AP-CML, BP-CML, and Ph+ ALL. Gastrointestinal hemorrhage and
subdural hematoma were the most commonly reported serious bleeding
events occurring in 1% (4/449) each. Most hemorrhagic events, but
not all, occurred in patients with grade 4 thrombocytopenia.
Interrupt Iclusig for serious or severe hemorrhage and
evaluate.
Fluid Retention: Fluid retention events judged as serious
occurred in 4% (18/449) of patients treated with Iclusig. One
instance of brain edema was fatal. For fluid retention events
occurring in >2% of the patients (treatment-emergent), serious
cases included: pleural effusion (7/449, 2%), pericardial effusion
(4/449, 1%), and edema peripheral (2/449, <1%).
In total, fluid retention occurred in 31% of the patients. The
most common fluid retention events were peripheral edema (17%),
pleural effusion (8%), pericardial effusion (4%) and peripheral
swelling (3%).
Monitor patients for fluid retention and manage patients as
clinically indicated. Interrupt, reduce, or discontinue Iclusig as
clinically indicated.
Cardiac arrhythmias: Arrhythmias occurred in 19% (86/449)
of Iclusig-treated patients, of which 7% (33/449) were grade 3 or
greater. Arrhythmia of ventricular origin was reported in 3% (3/86)
of all arrhythmias, with one case being grade 3 or greater.
Symptomatic bradyarrhythmias that led to pacemaker implantation
occurred in 1% (3/449) of Iclusig-treated patients.
Atrial fibrillation was the most common arrhythmia and occurred
in 7% (31/449) of patients, approximately half of which were grade
3 or 4. Other grade 3 or 4 arrhythmia events included syncope (9
patients; 2.0%), tachycardia and bradycardia (2 patients each
0.4%), and electrocardiogram QT prolonged, atrial flutter,
supraventricular tachycardia, ventricular tachycardia, atrial
tachycardia, atrioventricular block complete, cardio-respiratory
arrest, loss of consciousness, and sinus node dysfunction (1
patient each 0.2%). For 27 patients, the event led to
hospitalization.
In patients with signs and symptoms suggestive of slow heart
rate (fainting, dizziness) or rapid heart rate (chest pain,
palpitations or dizziness), interrupt Iclusig and evaluate.
Myelosuppression: Myelosuppression was reported as an
adverse reaction in 59% (266/449) of Iclusig-treated patients and
grade 3/4 myelosuppression occurred in 50% (226/449) of patients.
The incidence of these events was greater in patients with AP-CML,
BP-CML, and Ph+ ALL than in patients with CP-CML.Severe
myelosuppression (Grade 3 or 4) was observed early in treatment,
with a median onset time of 1 month (range <1-40 months). Obtain
complete blood counts every 2 weeks for the first 3 months and then
monthly or as clinically indicated, and adjust the dose as
recommended.
Tumor Lysis Syndrome: Two patients (<1%, one with
AP-CML and one with BP-CML) treated with Iclusig developed serious
tumor lysis syndrome. Hyperuricemia occurred in 7% (31/449) of
patients. Due to the potential for tumor lysis syndrome in patients
with advanced disease, ensure adequate hydration and treat high
uric acid levels prior to initiating therapy with Iclusig.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS):
Postmarketing cases of reversible posterior leukoencephalopathy
syndrome (RPLS—also known as Posterior Reversible Encephalopathy
Syndrome (PRES)) have been reported in Iclusig-treated patients.
RPLS is a neurological disorder that can present with signs and
symptoms such as seizure, headache, decreased alertness, altered
mental functioning, vision loss, and other visual and neurological
disturbances. Hypertension is often present and diagnosis is made
with supportive findings on magnetic resonance imaging (MRI) of the
brain. If RPLS is diagnosed, interrupt Iclusig treatment and resume
treatment only once the event is resolved and if the benefit of
continued treatment outweighs the risk of RPLS.
Compromised Wound Healing and Gastrointestinal
Perforation: Since Iclusig may compromise wound healing,
interrupt Iclusig for at least 1 week prior to major surgery.
Serious gastrointestinal perforation (fistula) occurred in one
patient 38 days post-cholecystectomy.
Embryo-Fetal Toxicity: Based on its mechanism of action
and findings from animal studies, Iclusig can cause fetal harm when
administered to a pregnant woman. In animal reproduction studies,
oral administration of ponatinib to pregnant rats during
organogenesis caused adverse developmental effects at exposures
lower than human exposures at the recommended human dose. Advise
pregnant women of the potential risk to the fetus. Advise females
of reproductive potential to use effective contraception during
treatment with Iclusig and for 3 weeks after the last dose.
Most Common Adverse Reactions: Overall, the most common
non-hematologic adverse reactions (≥20%) were abdominal pain, rash,
constipation, headache, dry skin, fatigue, hypertension, pyrexia,
arthralgia, nausea, diarrhea, lipase increased, vomiting, myalgia
and pain in extremity. Hematologic adverse reactions included
thrombocytopenia, anemia, neutropenia, lymphopenia, and
leukopenia.
Please see the full U.S. Prescribing Information
for Iclusig, including the Boxed Warning.
Iclusig is a registered trademark of ARIAD Pharmaceuticals,
Inc.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts is focused on discovering, developing and
commercializing precision therapies for patients with rare cancers.
ARIAD is working on new medicines to advance the treatment of rare
forms of chronic and acute leukemia, lung cancer and other rare
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 related to the
continued clinical benefit, durability of response and safety
profile of Iclusig, our efforts to understand the optimal dose of
Iclusig in the OPTIC trial, and our plans to report initial results
from the OPTIC trial, 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 ability to
successfully commercialize and generate profits from sales of our
products; 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;
competition from alternative therapies; our reliance on the
performance of third-party manufacturers, specialty pharmacies,
distributors and other collaborators for the supply, distribution,
development and/or commercialization 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
and government investigations; our operations in foreign countries
with or through third parties; 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161129005510/en/
ARIAD Pharmaceuticals, Inc.For InvestorsManmeet Soni,
617-621-2286Manmeet.soni@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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