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ARIAD Announces Iclusig Data Presentations at Annual American Society of Hematology Meeting

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ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced the schedule of several data presentations on Iclusig(R) (ponatinib) that will take place at the 56th Annual Meeting of the American Society of Hematology (ASH) being held in San Francisco, December 6 to 9, 2014. A total of 17 abstracts were accepted at ASH. The schedule and meeting location for key sessions at ASH, together with the abstract information, are listed below:

Oral Presentations:

Title:

Achieving Early Landmark Response is Predictive of Outcomes
in Heavily Pretreated Patients with Chronic Phase Chronic Myeloid
Leukemia (CP-CML) Treated with Ponatinib

Oral Session::

Chronic Myeloid Leukemia – Prognosis and Therapy

Date & Time:

Monday, December 8, 2014, 2:45 p.m., Presentation at 3:00 p.m.

Abstract No.:

72705

Presenter:

Martin C. M”uller, M.D. (Medical Clinic, University Hospital Mannheim,
Mannheim, Germany)

Location: Moscone Center, West Building 3001-3003-3014-3016
Title:

A Phase 3 Trial of Ponatinib Compared with Imatinib in Patients with
Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase CP-CML

Oral Session: Chronic Myeloid Leukemia – Prognosis and Therapy
Date & Time: Monday, December 8, 2014, 2:45 p.m., Presentation at 3:15 p.m.
Abstract No.: 70542
Author: Jeff H. Lipton, Ph.D., M.D. (Princess Margaret Hospital, Toronto)
Location: Moscone Center, West Building 3001-3003-3014-3016

Clinical Poster Presentations:

Title:

High-Resolution Analysis of the Relationship between Dose and
Molecular Response in CP-CML Patients Treated with Ponatinib or
Imatinib

Poster Session: Chronic Myeloid Leukemia – Therapy: Poster II
Date & Time: Sunday, December 7, 2014, 6:00 – 8:00 p.m.
Abstract No.: 72342
Author: Justin R. Pritchard, Ph.D. (ARIAD Pharmaceuticals, Inc.)
Location: Moscone Center, West Building, Level 1
Title:

Long-term Follow-up of Ponatinib Efficacy and Safety in the Phase
2 PACE Trial

Poster Session: Chronic Myeloid Leukemia – Therapy: Poster III
Date & Time: Sunday, December 7, 2014, 6:00 – 8:00 p.m.
Abstract No.: 73035
Presenter:

Jorge E. Cortes, M.D. (The University of Texas MD Anderson
Cancer Center)

Location: Moscone Center, West Building, Level 1
Title:

Long-Term Follow-up of a Phase 1 Study of Ponatinib in Patients with
Chronic-Phase Chronic Myeloid Leukemia (CP-CML)

Poster Session: Chronic Myeloid Leukemia – Therapy: Poster III
Date & Time: Monday, December 8, 2014 at 6:00 – 8:00 p.m.
Abstract No.: 73603
Presenter: Moshe Talpaz, M.D. (University of Michigan Comprehensive Cancer Center)
Location: Moscone Center, West Building, Level 1
Title:

Ponatinib Efficacy and Safety in Patients with the T315I Mutation:
Long-Term Follow-up of Phase 1 and Phase 2 (PACE) Trials

Poster Session: Chronic Myeloid Leukemia – Therapy: Poster III
Date & Time: Monday, December 8, 2014, 6:00 – 8:00 p.m.
Abstract No.: 70201
Presenter: Michael J. Mauro, M.D. (Memorial Sloan Kettering Cancer Center)
Location: Moscone Center, West Building, Level 1
Title:

Impact of Dose Intensity of Ponatinib on Selected Adverse Events:
Multivariate Analyses from a Pooled Population of Clinical Trial Patients

Poster Session: Chronic Myeloid Leukemia -Therapy: Poster III
Date & Time: Monday, December 8, 2014, 6:00 – 8:00 p.m.
Abstract No.: 67858
Presenter: Ronald K. Knickerbocker, Ph.D. (ARIAD Pharmaceuticals, Inc.)
Location: Moscone Center, West Building, Level 1
Title:

Ponatinib as Frontline Therapy for Patients with Chronic
Myeloid Leukemia in Chronic Phase

Poster Session: Chronic Myeloid Leukemia – Therapy: Poster III
Date & Time: Monday, December 8, 2014, 6:00 – 8:00 p.m.
Abstract No.: 74084
Presenter:

Preetesh Jain, M.D., Ph.D. (The University of Texas MD Anderson
Cancer Center)

Location: Moscone Center, West Building, Level 1

Preclinical Poster Presentations:

Title:

Comparative TKI Profiling Analyses to Explore Potential Mechanisms
of Ponatinib-Associated Arterial Thrombotic Events

Poster Session:

Chronic Myeloid Leukemia – Biology and Pathophysiology, Excluding
Therapy: Poster 1

Date & Time: Saturday, December 6, 2014, 5:30 – 7:30 p.m.
Abstract No.: 73920
Presenter: Victor M. Rivera, Ph.D. (ARIAD Pharmaceuticals, Inc.)
Location: Moscone Center, West Building, Level 1

Health Economics and Outcomes Research Poster Presentations:

Title:

Benefit-Risk of Ponatinib vs. Bosutinib in Chronic Phase Chronic
Myeloid Leukemia Patients who Failed Two Prior Tyrosine Kinase
Inhibitors: an indirect comparison

Poster Session:

Chronic Myeloid Leukemia – Therapy:Poster II

Date & Time: Sunday, December 7, 2014, 6:00 – 8:00 p.m.
Abstract No.: 74548
Presenter: Moshe Yair Levy, M.D. (Baylor University Med Center, Dallas, TX)
Location: Moscone Center, West Building, Level 1
Title:

Comparative Efficacy Among 3rd Line Post-Imatinib Chronic Phase Chronic
Myeloid Leukemia Patients after Failure of Dasatinib or Nilotinib Tyrosine
Kinase Inhibitors

Poster Session: Chronic Myeloid Leukemia – Therapy: Poster III
Date & Time: Monday, December 8, 2014, 6:00 – 8:00 p.m.
Abstract No.: 73075
Presenter:

Jeffrey H. Lipton, M.D., Ph.D., (Ontario Cancer Institute,
Princess Margaret Hospital)

Location: Moscone Center, West Building, Level 1

About Iclusig(R) (ponatinib) tablets

Iclusig is approved in the U.S., EU and Switzerland. Iclusig is a kinase inhibitor indicated in the U.S. for the:

o 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).

oTreatment 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.

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.

Vascular Occlusion: Arterial and venous thrombosis and occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures have occurred in at least 27% of Iclusig-treated patients from the phase 1 and phase 2 trials. Iclusig can also cause recurrent or multi-site vascular occlusion. Overall, 20% of Iclusig-treated patients experienced an arterial occlusion and thrombosis event of any grade. Fatal and life-threatening vascular occlusion has occurred within 2 weeks of starting Iclusig treatment and in patients treated with average daily dose intensities as low as 15 mg per day. The median time to onset of the first vascular occlusion event was 5 months. Patients with and without cardiovascular risk factors have experienced vascular occlusion although these events were more frequent with increasing age and in patients with prior history of ischemia, hypertension, diabetes, or hyperlipidemia. Interrupt or stop Iclusig immediately in patients who develop vascular occlusion events.

Heart Failure: Fatal and serious heart failure or left ventricular dysfunction occurred in 5% of Iclusig-treated patients (22/449). Eight percent of patients (35/449) experienced any grade of heart failure or left ventricular dysfunction. Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig. Consider discontinuation of Iclusig in patients who develop serious heart failure.

Hepatotoxicity: Iclusig can cause hepatotoxicity, including liver failure and death. Fulminant hepatic failure leading to death occurred in an Iclusig-treated patient within one week of starting Iclusig. Two additional fatal cases of acute liver failure also occurred. The fatal cases occurred in patients with blast phase CML (BP-CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Severe hepatotoxicity occurred in all disease cohorts. Iclusig treatment may result in elevation in ALT, AST, or both. 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 hypertension (defined as systolic BP>=140 mm Hg or diastolic BP>=90 mm Hg on at least one occasion) occurred in 67% of patients (300/449). Eight patients treated with Iclusig (2%) experienced treatment-emergent symptomatic hypertension as a serious adverse reaction, including one patient (<1%) with hypertensive crisis. Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath. In 131 patients with Stage 1 hypertension at baseline, 61% (80/131) 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.

Pancreatitis: Clinical pancreatitis occurred in 6% (28/449) of patients (5% Grade 3) treated with Iclusig. Pancreatitis resulted in discontinuation or treatment interruption in 6% of patients (25/449). The incidence of treatment-emergent lipase elevation was 41%. 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.

Neuropathy: Peripheral and cranial neuropathy have occurred in Iclusig-treated patients. Overall, 13% (59/449) of Iclusig-treated patients experienced a peripheral neuropathy event of any grade (2%, grade 3/4). In clinical trials, the most common peripheral neuropathies reported were peripheral neuropathy (4%, 18/449), paresthesia (4%, 17/449), hypoesthesia (2%, 11/449), and hyperesthesia (1%, 5/449). Cranial neuropathy developed in 1% (6/449) of Iclusig-treated patients (<1% grade 3/4). Of the patients who developed neuropathy, 31% (20/65) 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 3% of Iclusig-treated patients. Conjunctival or corneal irritation, dry eye, or eye pain occurred in 13% of patients. Visual blurring occurred in 6% of the patients. Other ocular toxicities include cataracts, glaucoma, iritis, iridocyclitis, and ulcerative keratitis. Conduct comprehensive eye exams at baseline and periodically during treatment.

Hemorrhage: Serious bleeding events, including fatalities, occurred in 5% (22/449) of patients treated with Iclusig. Hemorrhagic events occurred in 24% of patients. The incidence of serious bleeding events was higher in patients with accelerated phase CML (AP-CML), BP-CML, and Ph+ ALL. Most hemorrhagic events, but not all occurred in patients with grade 4 thrombocytopenia. Interrupt Iclusig for serious or severe hemorrhage and evaluate.

Fluid Retention: Serious fluid retention events occurred in 3% (13/449) of patients treated with Iclusig. One instance of brain edema was fatal. In total, fluid retention occurred in 23% of the patients. The most common fluid retention events were peripheral edema (16%), pleural effusion (7%), and pericardial effusion (3%). Monitor patients for fluid retention and manage patients as clinically indicated. Interrupt, reduce, or discontinue Iclusig as clinically indicated.

Cardiac Arrhythmias: Symptomatic bradyarrhythmias that led to a requirement for pacemaker implantation occurred in 1% (3/449) of Iclusig-treated patients. Advise patients to report signs and symptoms suggestive of slow heart rate (fainting, dizziness, or chest pain). Supraventricular tachyarrhythmias occurred in 5% (25/449) of Iclusig-treated patients. Atrial fibrillation was the most common supraventricular tachyarrhythmia and occurred in 20 patients. For 13 patients, the event led to hospitalization. Advise patients to report signs and symptoms of rapid heart rate (palpitations, dizziness). Interrupt Iclusig and evaluate.

Myelosuppression: Severe (grade 3 or 4) myelosuppression occurred in 48% (215/449) of patients treated with Iclusig. The incidence of these events was greater in patients with AP-CML, BP-CML and Ph+ ALL than in patients with CP-CML. 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%) with advanced disease (AP-CML, BP-CML, or Ph+ ALL) treated with Iclusig developed serious tumor lysis syndrome. Hyperuricemia occurred in 7% (30/449) of patients overall; the majority had CP-CML (19 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.

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: Iclusig can cause fetal harm. If Iclusig is used during pregnancy, or if the patient becomes pregnant while taking Iclusig, the patient should be apprised of the potential hazard to the fetus. Advise women to avoid pregnancy while taking Iclusig.

Most common non-hematologic adverse reactions: (>=20%) were hypertension, rash, abdominal pain, fatigue, headache, dry skin, constipation, arthralgia, nausea, and pyrexia. Hematologic adverse reactions included thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia.

Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.

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).

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