Ariad Pharmaceuticals said today it granted Angelini Pharma exclusive rights to commercialize Iclusig® (ponatinib) in seven Central and Eastern European nations.
Ariad said it will generate $7.3 million in upfront and milestone payments associated with commercial launches, plus an additional “substantial” undisclosed share of Iclusig sales in the region, through the deal with Angelini. The commercial launches are expected to begin in 2015.
Iclusig is a kinase inhibitor whose primary target is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
In Central and Eastern Europe, Angelini has agreed to oversee sales and marketing, medical affairs, regulatory and reimbursement support for Iclusig—as well as book sales of the drug, to be supplied by Ariad. The deal covers Bulgaria, the Czech Republic, Hungary, Poland, Romania, Slovakia, and Slovenia.
“Angelini has the experience and geographic reach to market and distribute Iclusig in Central and Eastern Europe,” Marty J. Duvall, Ariad’s president and chief commercial officer, said in a statement. “Angelini will be an important partner for us in this region.”
Ariad will retain its status as Marketing Authorization Holder of Iclusig in Europe, and will manage the distribution out of its European headquarters in Lausanne, Switzerland.
As a result of the commercialization deal, Iclusig will be available to patients with resistant and intolerant Philadelphia-positive leukemias in more than 23 countries in Europe.
The deal covers all indications approved by the European Medicine Agency (EMA). Those indications include CML in its different stages known as chronic, accelerated and blast phases, and Ph+ ALL.
Iclusig is also indicated by the EMA for patients who cannot tolerate or do not respond to dasatinib or (for patients with CML) nilotinib, and in whom subsequent treatment with imatinib is not considered appropriate. It is also used in patients who have the T315I mutation, which makes them resistant to treatment with imatinib, dasatinib or nilotinib. Ariad received marketing authorization approval for Iclusig from EMA in 2013.
The deal is the second in as many weeks for Ariad focused on commercializing Iclusig beyond the U.S., Western Europe and Australia. On December 23, Ariad said it gave Otsuka Pharmaceutical exclusive rights to market Iclusig in China, Japan and eight other Asian countries, as well as fund future clinical trials in those countries.
The Otsuka deal—which could net Ariad as much as $77.5 million-plus—also covered Indonesia, South Korea, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam.
The Angelini and Otsuka deals cap a 2014 which began with Iclusig rising from the dead, resuming U.S. commercial sales with a narrower patient subpopulation and a new boxed warning—both designed to address concerns that drove the company last year to halt a Phase III trial, pull the product off U.S. shelves, and lay off about 40% of its U.S. staff or 160 employees.