ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced that it is temporarily suspending the marketing and commercial distribution of Iclusig ® (ponatinib), a treatment for patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), in the United States, while it continues to negotiate updates to the U.S. prescribing information for Iclusig and implementation of a risk mitigation strategy.
The Company’s actions have been taken in response to a request by the U.S. Food and Drug Administration (FDA) yesterday afternoon. ARIAD believes that Iclusig is an important medicine for patients with resistant or intolerant Philadelphia-positive leukemias and is actively working with the FDA on actions to achieve the resumption of marketing of Iclusig.
Today’s Conference Call at 9:00 a.m. ET
ARIAD management will host a conference call and webcast to discuss these actions today, October 31 at 9:00 a.m. ET. The live webcast can be accessed by visiting the investor relations section of the Company’s website at http://investor.ariad.com. The call can be accessed by dialing 800-510-0146 (U.S.) or +1 617-614-3449 (international) and providing the participant code 74034136. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for three weeks.About Iclusig ® (ponatinib) Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, a common mutation which has been associated with resistance to other approved TKIs.