Date: 2014-12-30
Type of information: Commercialisation agreement
Compound: Iclusig® (ponatinib)
Company: Ariad Pharmaceuticals (USA - MA) Angelini Pharma (Italy)
Therapeutic area: Cancer - Oncology
Type agreement: commercialisation
Action mechanism: 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).
Disease: chronic myeloid leukemia (CML), Philadelphia -chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Details: * On December 30, 2014, Ariad Pharmaceuticals and Angelini Pharma, through the Austrian subsidiary CSC Pharmaceuticals , announced that Ariad has granted Angelini exclusive rights to commercialize Iclusig® (ponatinib) for the indications approved by the European Medicine Agency (EMA) in Central and Eastern Europe . These countries include Bulgaria , the Czech Republic , Hungary , Poland , Romania , Slovakia and Slovenia . With this distributorship in place, Iclusig will be available to patients with resistant and intolerant Philadelphia -positive leukemias in more than 23 countries in Europe . Under the terms of the agreement, Ariad will remain the Marketing Authorization Holder of Iclusig®, and Ariad will manage this distributorship out of its European headquarters in Lausanne , Switzerland . Angelini will be responsible for sales and marketing, medical affairs, regulatory and reimbursement support. Angelini will book sales of Iclusig® while Ariad will supply packaged drug to Angelini. An upfront payment to Ariad and milestones associated with commercial launches will total approximately $7.3 million . Additionally, Angelini will provide Ariad with a substantial share of Iclusig sales in the region. Ariad received Marketing Authorization Approval for Iclusig from the European Medicine Agency in July 2013 . The commercial launches of Iclusig® in these Central and Eastern European countries are expected to begin in 2015.
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