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
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
Bristol-Myers Squibb Company
) Sprycel (dasatinib) or
) 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 presently carries a Zacks Rank #1 (Strong
ARIAD PHARMA (ARIA): Free Stock Analysis
BRISTOL-MYERS (BMY): Free Stock Analysis
CYTOKINETCS INC (CYTK): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
To read this article on Zacks.com click here.