Ariad and Otsuka gain regulatory approval for Iclusig in Japan

US specialty pharma firm Ariad Pharmaceuticals (Nasdaq: ARIA) says its partner Otsuka Pharmaceutical (TYO: 4768) has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for Iclusig (ponatinib) for the treatment of chronic myeloid leukemia (CML) resistant or intolerant to preceding drug treatment and relapsed or treatment resistant Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

“Our collaboration with Otsuka has resulted in today’s approval of Iclusig in Japan, providing an important new treatment for patients with refractory CML and Ph+ ALL,” stated Paris Panayiotopoulos, president and chief executive of Ariad, adding: “Japan represents a large market opportunity for Iclusig and its first approval in Asia. We are committed to expanding patient access and to continuing our successful partnership with Otsuka as evidenced by recent marketing applications for Iclusig submitted in Korea and Taiwan.”

This approval triggers a $10 million milestone payment to Ariad from Otsuka under the parties’ collaboration agreement entered in December 2014, at which point Ariad received an upfront payment of $75.5 million from the Japanese drugmaker. Otsuka filed for approval of Iclusig in January this year.