Ariad Pharmaceuticals Inc. (ARIA - Analyst Report) shares slipped approximately 66% on Oct 9, 2013 to close at $5.83 following the company’s announcement that the U.S. Food and Drug Administration has placed a partial clinical hold on enrolling new patients in studies on its oncology drug Iclusig due to safety issues.
However, the company will resume studies after dose changes, including reduction in the current 45 mg daily dose of Iclusig and other modifications depending upon agreement with the FDA.
Additionally, the dosage of Iclusig in the EPIC study will be reduced to 30 mg daily unless the patients achieve a major molecular response. The dose will be further reduced to 15 mg daily once the patients are successful in achieving such response. These changes are in line with the Data Monitoring Committee’s recommendation.
Iclusig is currently in the phase III EPIC study, in which it is being compared to Novartis’ (NVS - Analyst Report) Gleevec (imatinib) in patients with newly diagnosed chronic myeloid leukemia (CML). Ariad is presently enrolling patients for the study with interim data likely to come out in the third quarter of 2014.
Furthermore, according to the changes announced, patients who have suffered heart attack or stroke due to arterial thrombosis will now be ineligible for inclusion in the Iclusig study.
In Jul 2013, Ariad gained EU approval for Iclusig for a couple of indications. The first indication is 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 #4 (Sell). Currently, stocks which look more attractive include Actelion Ltd. (ALIOF - Snapshot Report) with a Zacks Rank #1 (Strong Buy) and Alexion Pharmaceuticals, Inc. (ALXN - Analyst Report) with a Zacks Rank #2 (Buy).