ARIAD Announces the Commercial Availability of Iclusig (Ponatinib) for Patients with Refractory Philadelphia-Positive Leukemias in the U.S.

--(BUSINESS WIRE)-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the commercial availability of Iclusig® (ponatinib) for adult patients with refractory chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in the United States. ARIAD has begun shipping Iclusig to Biologics, Inc., its exclusive specialty pharmacy, which is now filling prescriptions from physicians and distributing the cancer medicine to patients.

We are pleased to again have Iclusig commercially available to patients in the United States, stated Marty J. Duvall, executive vice president and chief commercial officer for ARIAD. Iclusig is now in our distribution channel with Biologics, and our dedicated sales force will begin promoting Iclusig immediately. We are highly confident in our commercial launch of Iclusig and look forward to reporting on our progress on a quarterly basis.

Last month, the U.S. Food and Drug Administration (FDA) approved revised U.S. Prescribing Information (USPI) and a communications Risk Evaluation and Mitigation Strategy (REMS) for Iclusig that allowed for the immediate resumption of its marketing and commercial distribution. The USPI includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers. Iclusig is now indicated for the treatment of adult patients with:

T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia, or
Chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ acute lymphoblastic leukemia for whom no other tyrosine-kinase inhibitor therapy is indicated.
The starting dose of Iclusig remains 45 mg daily.

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