ARIAD Pharmaceuticals signs pharma deals with big pharma Otsuka to commercialize ARIAD’s Iclusig (ponatinib) in Japan and nine other Asian countries and to fund future clinical trials in those countries.
ARIAD will lead the completion of the Japanese New Drug Application for Iclusig, and Otsuka will file the NDA on behalf of both companies for regulatory approval in resistant and intolerant chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in 2015.
Iclusig is an approved BCR-ABL inhibitor in the United States, Europe and Australia.
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The pharma deals 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 Philadelphia-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.
ARIAD will continue to fund the completion of its ongoing pivotal trial of Iclusig that will form the basis of the filing for regulatory approval in Japan, while Otsuka will fund additional agreed-upon clinical studies in the Territory.
For ARIAD-sponsored global studies that include sites in Japan, Otsuka has the option to contribute to the funding and gain access to the data for use in the Territory.
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