Ariad Pharmaceuticals Inc. recently announced that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has given a favorable opinion on the marketing authorization application for Iclusig. Ariad is looking to get Iclusig approved for two indications.
The first indication relates to the treatment of adults suffering from chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant and intolerant to Bristol-Myers Squibb Company’s (BMY - Free Report) Sprycel (dasatinib) or Novartis AG’s (NVS - Free Report) Tasigna (nilotinib). For these patients, subsequent treatment with Novartis’ Glivec (imatinib) is considered clinically inappropriate or they have the T3151 mutation.
The second indication relates to the treatment of adults suffering from Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL), and who are resistant and intolerant to Sprycel. Subsequent treatment with Glivec is not considered clinically appropriate for these patients or they also have the T3151 mutation.
A final verdict on the approval of status Iclusig by the EMA is expected in mid-2013.
We remind investors that Iclusig is already approved in the US. On Dec 14, 2012, Ariad announced that Iclusig gained US Food and Drug Administration (FDA) approval for the treatment of CML and Ph+ALL in patients resistant or intolerant to prior tyrosine kinase inhibitor therapy.
We are encouraged by the positive CHMP recommendation for Iclusig. With the CHMP issuing a positive opinion, we believe chances of gaining EU approval are high. We expect investor focus to remain on the EU approvability status and the commercialization of Iclusig in the US.
Currently, Ariad carries a Zacks Rank #3 (Hold). Other biotech stocks that look better-positioned than Ariad include Cytokinetics, Inc. (CYTK - Free Report) . Cytokinetics presently carries a Zacks Rank #1 (Strong Buy).