Date: 2015-06-10
Type of information: Licensing agreement
Compound: Iclusig™
Company: Ariad Pharmaceuticals (USA - MA) Paladin Labs (Canada)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism: tyrosine kinase inhibitor. Iclusig® (ponatinib) is a kinase inhibitor. Its primary target is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukaemia (CML) and Philadelphia -chromosome positive acute lymphoblastic leukaemia (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 both native BCR-ABL and isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which is a common mutation among resistant patients.
Disease:
Details: * On June 10, 2015, Ariad Pharmaceuticals and Paladin Labs , an operating company of Endo International, 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.
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.
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