ARIAD Pharmaceuticals, Inc.’s share price has been falling miserably ever since it announced the temporary suspension of the marketing and commercial distribution of its oncology drug, Iclusig, in the U.S. on Oct 31, 2013. The share price fell more than 44% immediately after the news. Although it regained around 17% on the following day, the downward trend continued over the last few trading sessions.
Iclusig is approved for the treatment of patients suffering from resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was launched in the U.S. in Jan 2013.
ARIAD suspended the marketing and commercial distribution of Iclusig following instruction from the U.S. Food and Drug Administration’s (FDA). ARIAD meanwhile continues to negotiate with the U.S. regulatory body to update the U.S. prescribing information for the drug as well implement a comprehensive risk mitigation strategy. We expect investor focus to stay on further updates on Iclusig.
ARIAD stated in its conference call that the suspension of Iclusig was limited to the U.S. currently. It has informed other regulatory authorities including the European Medicines Agency (EMA) about this suspension in the U.S.
Last month, ARIAD also discontinued a phase III EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) study on Iclusig. In the EPIC study, Iclusig was being compared to Novartis’ (NVS - Free Report) Gleevec in patients with newly diagnosed CML. The decision was taken in the wake of arterial thrombotic events observed in patients treated with Iclusig. The randomized (1:1), two-arm, multicenter EPIC study was supposed to evaluate 500 patients of at least 18 years of age. The primary endpoint of the study was major molecular response at 1 year of treatment.
In Jul 2013, ARIAD gained EU approval for Iclusig for a couple of indications. The first indication was the treatment of chronic phase, accelerated phase or blast phase CML in adults who do not respond to or cannot tolerate Sprycel or Tasigna. It is also approved for patients in whom Gleevec is not appropriate as a subsequent treatment. The second indication covers the treatment of Ph+ ALL in adults unresponsive to Sprycel. It also includes patients for whom Gleevec is not clinically appropriate. Iclusig is also approved for patients who have the T315I mutation.
ARIAD currently carries a Zacks Rank #3 (Hold). Meanwhile stocks such as Actelion Ltd. and AMAG Pharmaceuticals, Inc. (AMAG - Free Report) look better positioned with a Zacks Rank #1 (Strong Buy).