Ariad Pharmaceuticals has signed an agreement with Otsuka Pharmaceutical to commercialize Iclusig and fund its future clinical trials in Japan and nine other Asian countries.
Under the terms of agreement, Ariad will lead the completion of the Japanese new drug application (NDA) for Iclusig, while Otsuka will file the NDA 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 inhibitor of BCR-ABL, an abnormal tyrosine kinase that is expressed in CML and Ph+ ALL, in the US, Europe and Australia.
Ariad chairman and chief executive officer Harvey Berger said: "Over the past several years, we have worked with the leading hematology experts in Japan and have run the Phase 1/2 clinical trial that will form the basis for our marketing authorization application.
"Together with Otsuka, we will be able to make this cancer medicine available to refractory Philadelphia-positive leukemia patients in need of new treatment options."
Otsuka Pharmaceutical president and representative director Taro Iwamoto said: "The future arrival of ARIAD’s ponatanib in Japan and elsewhere in Asia will be an important evolution for patients with CML and Philadelphia-positive ALL with BCR-ABL gene expression, said to be particularly difficult to treat.
"Treatments have been inadequate for patients with these life-threatening conditions and we aim to contribute to improve the treatment available to them."
Otsuka will make an upfront payment of $77.5m to Ariad in return for exclusive rights to market Iclusig in Japan and nine other Asian countries.
Following approvals in the territory, Otsuka will conduct sales activities and record sales, with Ariad also receiving a substantial share of net product sales.