ARIAD Pharmaceuticals, Inc.
) recently submitted a Marketing Authorization Application (MAA)
for its BCR-ABL inhibitor, ponatinib, to the European Medicines
Agency (EMA). ARIAD is looking to get the candidate approved in the
EU for use in adult patients suffering from resistant or intolerant
chronic myeloid leukemia (CML) and Philadelphia-chromosome positive
acute lymphoblastic leukemia (Ph+ ALL).
ARIAD had requested accelerated assessment of the MAA for its
investigational candidate, which was granted by the Committee for
Medicinal Products for Human Use (CHMP).
In June 2012, ARIAD had reported positive data on ponatinib from
the PACE trial conducted in patients suffering from CML and Ph+
ALL. Data showed that 54% of chronic-phase CML patients (including
70% patients who had T315I mutation) were successful in achieving a
major cytogenetic response (MCyR). ARIAD submitted these data to
support its MAA for ponatinib.
Notably, in July this year, ARIAD also applied for US approval
of ponatinib for the same indication. We note that ARIAD's new drug
application (NDA) is a rolling submission. The company expects to
complete the NDA submission later in the third quarter. The company
anticipates potential approval and subsequent launch in the US in
the first quarter of 2013.
ARIAD also intends to commercialize ponatinib beyond Europe and
the US. The company recently initiated a multi-center phase I/II
clinical trial with ponatinib in Japan, the third largest CML
market in the world.
The Japanese trial is evaluating ponatinib in patients with CML
who have failed treatment with
Bristol-Myers Squibb Company
) Sprycel (dasatinib) or
) Tasigna (nilotinib) or with Ph+ ALL who have failed treatment
with tyrosine kinase inhibitors.
We currently have a Neutral recommendation on ARIAD. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.
ARIAD PHARMA (ARIA): Free Stock Analysis Report
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