December 23, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Boston-area biopharma Ariad Pharmaceuticals has inked a $77.5 million deal with Japanese firm Otsuka Pharmaceutical Co., giving Otsuka the rights in 10 Asian countries to leukemia drug Iclusig. In addition to Japan, the rights will incorporate China, South Korea, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand and Vietnam.
Iclusig has shown success in trials for treating patients with refractory chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia. Iclusig is already an an approved BCR-ABL inhibitor in the United States, Europe and Australia.
Ariad said in a statement that it will continue to shepherd the drug through the Japanese regulatory process, with the hoped-for completion of the Japanese New Drug Application (NDA) for Iclusig. Otsuka will handle filing 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.
“This agreement meets one of our key strategic objectives – establishing a strong partnership with an experienced and committed Japanese pharmaceutical company to commercialize and co-develop Iclusig in Japan and Asia,” said Harvey Berger, chairman and chief executive officer of Ariad, in a statement. “Otsuka is building a leading hematology and oncology business in Japan and Asia and is an outstanding partner to successfully commercializing Iclusig in these markets.”
Under the terms of the deal, Otsuka will pay an upfront fee of $77.5 million to Ariad for the rights to Iclusig in Asia, then 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. Otsuka will also fund future trials.
Ariad said Otsuka’s familiarity with the local culture will be a help in achieving both approval and sales across the region.
“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,” said Berger. “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.”
Although Ariad will continue to bankroll a pivotal trial of Iclusig that will form the basis of the filing for regulatory approval in Japan, Otsuka will provide funding for additional clinical studies in the 10-nation Asian 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.
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,” said Otsuka Pharmaceutical President and Representative Director Taro Iwamoto. “Treatments have been inadequate for patients with these life-threatening conditions and we aim to contribute to improve the treatment available to them. ARIAD’s high-level drug discovery technology powered its discovery of ponatanib and Otsuka aims to maintain this momentum by making it part of our expanded portfolio in blood cancers from pre-treatment conditioning to treatments.”
