On December 30, 2014 ARIAD Pharmaceuticals and Angelini Pharma, through the Austrian subsidiary CSC Pharmaceuticals reported 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 (Press release Ariad, DEC 30, 2014, View Source [SID:1234501254]). 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.

“With this agreement, we continue to move towards having Iclusig available to patients in geographies outside of our own commercial footprint,” said Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. “Angelini will be an important partner for us in this region where, according to the EMA, there are approximately 8,000 patients living with chronic myeloid leukemia (CML) who may become resistant or intolerant to other approved tyrosine kinase inhibitors. Angelini has the experience and geographic reach to market and distribute Iclusig in Central and Eastern Europe.”

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.

“By partnering with ARIAD, we will be able to provide this important cancer medicine to patients in Central and Eastern Europe who have difficult-to-treat CML or Ph+ ALL and few options available to them,” said Gianluigi Frozzi, CEO of Angelini Pharma Division. “We look forward to a successful collaboration with ARIAD and to making Iclusig available to refractory CML and Ph+ ALL patients.”