CAMBRIDGE, Mass., & MONTREAL--(BUSINESS WIRE)--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.
- 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.
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.