ARIAD Confirms Accelerated FDA Approval of Iclusig

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that following apriority review, the U.S. Food and Drug Administration (FDA) has grantedaccelerated approval of Iclusig™ (ponatinib) for the treatment of adultpatients with chronic, accelerated or blast phase chronic myeloid leukemia(CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI)therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) that is resistant or intolerant to prior TKI therapy.“Today's FDA approval of Iclusig is an important advance in the treatment ofpatients with CML and Ph+ ALL who are resistant or intolerant to prior TKItherapy,” stated Harvey J. Berger, M.D., chairman and chief executive officerof ARIAD. “Within less than five years, we were able to bring Iclusig from thestart of clinical development to U.S. approval, achieving a major milestone inARIAD's history. We have now transformed ARIAD into a commercial oncologycompany addressing major unmet medical needs for cancer patients.”Approximately 5,000 new cases of CML are diagnosed each year in the U.S. CMLpatients treated with TKIs can develop resistance or intolerance over time tothese therapies. Iclusig is a targeted cancer medicine discovered anddeveloped at ARIAD. It was designed by ARIAD scientists using ARIAD's platformof computational chemistry and structure-based drug design to inhibit BCR-ABL,including drug-resistant mutants that arise during treatment. Iclusig is theonly TKI that demonstrates activity against the T315I gatekeeper mutation ofBCR-ABL, the most common mutation occurring in approximately ten percent ofpatients with drug resistance.