Ariad Pharmaceuticals, Inc.
) recently provided an update on its pipeline and the
commercialization of Iclusig in the US.
We remind investors that in Dec 2012, Iclusig gained the US
Food and Drug Administration (FDA) approval for the treatment of
CML and Ph+ALL in patients resistant or intolerant to the prior
tyrosine kinase inhibitor therapy.
Ariad said that during the first 12 weeks of Iclusig's launch
in the US, there were more than 225 unique prescribers of Iclusig
and nearly 200 unique accounts using the product. Iclusig is
being used to treat more than 325 patients.
About 65% of the prescribers are community based physicians
with the balance representing the academic setting. As the launch
progresses, usage by community based physicians is expected to
Meanwhile, Iclusig should gain approval in the EU in the
second quarter of 2013. In Mar 2013, the European Medicines
Agency's (EMA) Committee for Human Medicinal Products (CHMP) had
voted in favor of approving Iclusig for two indications namely,
chronic myeloid leukemia (CML) and Philadelphia-chromosome
positive acute lymphoblastic leukemia (Ph+ALL).
Once approved, Iclusig will be used for the second-line
treatment of patients who are resistant to
Bristol-Myers Squibb Company
) Sprycel (dasatinib) or
) Tasigna (nilotinib) or who have the T3151 mutation of
Ariad intends to submit regulatory applications for Iclusig in
Canada, Switzerland and Australia in the third quarter of
We note that Ariad is evaluating Iclusig in additional
studies. Iclusig is currently in the phase III EPIC study
(Evaluation of Ponatinib versus Imatinib in Chronic Myeloid
Leukemia), with interim results due in mid-2014.
The development process for AP26113 is also underway. The
company is developing AP26113 for anaplastic lymphoma kinase
(ALK) positive NSCLC patients with brain metastases.
Ariad currently carries a Zacks Rank #3 (Hold). We expect
investor focus to remain on the commercialization of Iclusig.
Other biopharma stocks that look better positioned than Ariad
Array BioPharma, Inc.
), which carries a Zacks Rank #2 (Buy).
ARIAD PHARMA (ARIA): Free Stock Analysis
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