ARIAD Pharmaceuticals, Inc.
) and its diagnostic collaborator, the privately held MolecularMD
Corporation recently announced that the latter has withdrawn its
Premarketing Approval (PMA) application with the US Food and Drug
Administration (FDA) for the BCR-ABL T315I mutation test. The
application was withdrawn on a voluntary basis.
The test was designed to identify the presence of T315I mutation
of BCR-ABL in patients suffering from chronic myeloid leukemia
(CML) and Philadelphia-chromosome positive acute lymphoblastic
leukemia (Ph+ ALL). MolecularMD was looking to get the test
approved as a companion diagnostic test, in combination with
ARIAD's BCR-ABL inhibitor, ponatinib.
MolecularMD's voluntary withdrawal was preceded by a
notification from the FDA. The US regulatory body's Center for
Devices and Radiological Health informed MolecularMD that BCR-ABL
T315I mutation test was no more considered as a combination
diagnostic test for ponatinib. The FDA stated in its guidance that
a companion diagnostic test, to gain PMA, requires information that
is essential for the safe and effective use of a therapeutic
In July this year, MolecularMD submitted the PMA application to
the US regulatory body for the BCR-ABL T315I mutation test as a
companion diagnostic to ponatinib.
We remind investors that last month, ARIAD announced the
submission of a Marketing Authorization Application (MAA) for
ponatinib, to the European Medicines Agency (EMA). ARIAD is looking
to get the candidate approved in the EU for treating adults
suffering from resistant or intolerant CML and 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).
ARIAD is also seeking US approval of ponatinib for the same
indication. The company expects to launch ponatinib in the US in
the first quarter of 2013 following the FDA approval.
ARIAD also intends to commercialize ponatinib beyond Europe and
the US. Last month the company initiated a multi-center phase I/II
clinical trial with ponatinib in Japan. Japan is one of the largest
CML markets in the world.
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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