ARIAD Pharmaceuticals, Inc.
) 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.
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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
) 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:
), 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
AMAG Pharmaceuticals, Inc.
) look better positioned with a Zacks Rank #1 (Strong Buy).