Otsuka To Commercialize ARIAD's Iclusig In Japan, Nine Other Asian Countries

(RTTNews) - ARIAD Pharmaceuticals, Inc. (ARIA) and Otsuka Pharmaceutical Co., Ltd. announced that they have entered into an agreement for Otsuka to commercialize ARIAD's Iclusig in Japan and nine other Asian countries and to fund future clinical trials in those countries.

According to the agreement, ARIAD will lead the completion of the Japanese New Drug Application or NDA for Iclusig, and Otsuka will file the NDA on behalf of both companies for regulatory approval in resistant and intolerant chronic myeloid leukemia or CML and -chromosome positive acute lymphoblastic leukemia in 2015. Iclusig is an approved BCR-ABL inhibitor in the United States, Europe and Australia.

It is noted that the agreement provides for Otsuka to receive exclusive rights to market Iclusig in Japan and nine other Asian countries in return for an upfront payment of $77.5 million to ARIAD, a milestone payment upon regulatory approval in Japan for patients with resistant and intolerant -positive leukemias, and additional milestone payments for approval in other indications.

Following approvals in the Territory, Otsuka will conduct sales activities and record sales. ARIAD will also receive a substantial share of net product sales.