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’s (BMY - Free Report) Sprycel (dasatinib) or Novartis AG’s (NVS - Free Report) 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.