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ARIAD (ARIA) Leukemia Drug Iclusig Gets Approval in Japan

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ARIAD Pharmaceuticals Inc. announced that its partner Otsuka Pharmaceutical Co., Ltd. has gained approval from the Japanese Pharmaceuticals and Medical Devices Agency for leukemia drug, Iclusig. Iclusig is approved for the treatment of patients with chronic myeloid leukemia (CML) resistant or intolerant to prior drug treatment, and relapsed or treatment-resistant Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
The approval has triggered a milestone payment of $10 million to ARIAD from Otsuka under the two companies’ collaboration agreement. In Dec 2014, ARIAD had entered into a collaboration with Otsuka for the commercialization and development of Iclusig in Japan and nine other Asian countries.
Given that Japan represents huge market opportunity for Iclusig and this marks the drug’s first approval in Asia, we are positive about the latest development on the regulatory front. Otsuka has also filed marketing applications for Iclusig in Korea and Taiwan.
We note that ARIAD has struck quite a few deals for the development and commercialization of Iclusig in various countries. These deals provide the company with a steady stream of funds in the form of upfront, milestone and other payments.
ARIAD has a non-dilutive synthetic-royalty financing agreement with PDL BioPharma (PDLI - Free Report) , under which the company could receive up to $200 million as revenue interest in exchange for royalties on net sales of Iclusig.
Further, in Jun 2016, ARIAD divested its European operations and licensed the rights to Iclusig in Europe and other select countries to Incyte Corporation (INCY - Free Report) . ARIAD is eligible to receive 32–50% of the European net sales, going forward.
Meanwhile, ARIAD completed the rolling submission of the new drug application for its most advanced pipeline candidate, brigatinib, to the FDA last month. The company is looking to get brigatinib approved for the treatment of metastatic ALK-positive non-small cell lung cancer in patients who are resistant or intolerant to Pfizer Inc.'s (PFE - Free Report) Xalkori.
If all goes well on the regulatory front, ARIAD could potentially launch brigatinib in 2017.

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