Under the terms of the agreement, ARIAD Pharmaceuticals (Israel) Ltd will be the Marketing Authorization Holder (MAH) of Iclusig in Israel, and Medison will be responsible for sales and marketing, medical affairs, regulatory support, as well as obtaining, in collaboration with ARIAD, the pricing and reimbursement approval of Iclusig.
"The agreement with Medison illustrates our ongoing commitment to provide patients access to Iclusig in geographies outside of our core commercial footprint," said Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. "Medison is uniquely qualified to provide the complete spectrum of integrated services for Iclusig in Israel, including a proven track record with oncology and hematology products."
ARIAD has submitted its Marketing Authorization Application for Iclusig in Israel, which is currently under review with the Israel Ministry of Health. Marketing approval and commercial launch of Iclusig are expected to occur in the second half of 2015.
"We are very pleased with our new partnership with ARIAD. It is another step in fulfilling Medison’s continuing vision to provide innovative and unique treatments to patients in Israel," said Meir Jakobsohn, Chief Executive Officer and Founder of Medison Pharma. "One of Medison’s main focuses is providing treatments in the field of hematology. ARIAD’s treatment offers new hope for refractory CML patients."
According to the EMA’s orphan drug designation and the HAEMACARE project, there are approximately 700 patients in Israel with CML.
"Iclusig is a very effective treatment option with utmost importance to CML or Ph+ALL patients who are resistant to dasatinib or nilotinib and for those patients with the T315I BCR-ABL mutation," said Prof. Arnon Nagler, director of hematology at Sheba Medical Center. "It is of vital importance that Iclusig be available to the Israeli market."