Date: 2014-12-26
Type of information: Commercialisation agreement
Compound: Iclusig® (ponatinib)
Company: Ariad Pharmaceuticals (USA - MA) Otsuka Pharmaceutical (Japan)
Therapeutic area: Cancer - Oncology
Type agreement: commercialisation
Action mechanism: Iclusig® (ponatinib) is a kinase inhibitor discovered by Ariad. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia -chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD\'s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.
Disease: rresistant and intolerant chronic myeloid leukemia (CML) and Philadelphia -chromosome positive acute lymphoblastic leukemia (Ph+ALL)
Details: * On December 23, 2014, Ariad Pharmaceuticals and Otsuka Pharmaceutical announced that they have entered into an agreement for 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 (NDA) for Iclusig, and Otsuka will file the NDA on behalf of both companies for regulatory approval in resistant and intolerant chronic myeloid leukemia (CML) and Philadelphia -chromosome positive acute lymphoblastic leukemia (Ph+ALL) in 2015. Iclusig® is an approved BCR-ABL inhibitor in the United States , Europe and Australia . A joint development and commercialization committee will oversee clinical development and commercialization of Iclusig® in the Territory, including approval of any development or commercialization plans. Otsuka will have exclusive commercial rights to Iclusig and will promote it as its sole tyrosine kinase inhibitor in the Territory. In addition to Japan , the other Asian countries that are included in this agreement are China , South Korea , Indonesia , Malaysia , the Philippines , Singapore , Taiwan , Thailand and Vietnam .
Financial terms: The agreement provides for Otsuka to receive exclusive rights to market Iclusig in Japan and nine other Asian countries (the \"Territory\") 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. V 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 Aria-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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