) recently announced positive data from the pivotal PACE study on
ponatinib. ARIAD is evaluating the candidate for use in heavily
pretreated patients, suffering from resistant and refractory
chronic myeloid leukemia (CML) and Philadelphia
chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
The data from the study showed that 57% of accelerated-phase
CML patients, including 50% of patients with the T315I mutation,
were successful in achieving a major hematologic response (MaHR).
We note that MaHR was the primary objective of the PACE study
with patients in an advanced stage of the disease.
Ponatinib is currently under US Food and Drug Administration
(FDA) review for patients suffering from resistant or CML or Ph+
ALL. The FDA's response should be out by March 27, 2013.
In August this year, ARIAD submitted a Marketing Authorization
Application (MAA) for ponatinib for the same indication to the
European Medicines Agency (EMA). ARIAD had requested accelerated
assessment of the MAA for the candidate, which was granted by the
Committee for Medicinal Products for Human Use (CHMP). Both the
US and the EU application of the candidate were based on positive
data from the PACE trial.
ARIAD also intends to commercialize ponatinib beyond Europe
and the US. In August this year, the company initiated a
multi-center phase I/II clinical trial with ponatinib in Japan,
one of the largest CML markets in the world.
We remind investors that companies like
) already have a presence in the CML market.
We expect investor focus to stay on the FDA's decision on the
approval of the candidate. We currently have a Neutral
recommendation on ARIAD. The stock carries a Zacks #3 Rank (Hold)
in the short run. Other pharma stocks like
) carry a #2 Rank (Hold).
ARIAD PHARMA (ARIA): Free Stock Analysis
INFINITY PHARMA (INFI): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
QUESTCOR PHARMA (QCOR): Free Stock Analysis
To read this article on Zacks.com click here.