Ariad Pharmaceuticals, Inc.
) recently presented pre-clinical data on Iclusig (ponatinib).
The company presented data which showed that Iclusig has the
potential to inhibit RET and FGFR. While it has been clinically
proved that RET is an oncogenic driver of medullary thyroid
cancer (MTC) and non-small cell lung cancer (NSCLC), FGFR is
mutated in endometrial, lung and other cancers.
The encouraging pre-clinical results support the investigation
of Iclusig in RET and FGFR-driven cancers. Ariad said that a
phase II investigator-sponsored study is scheduled to commence in
the second quarter of 2013 evaluating Iclusig in patients with
Meanwhile, Iclusig is already being evaluated in a phase II
investigator-sponsored study in patients with FGFR-driven
squamous cell carcinomas (SCCs). The study is currently enrolling
We note that Iclusig is already approved in the US for the
treatment of chronic, accelerated or blast phase chronic myeloid
leukemia (CML) or Philadelphia chromosome-positive acute
lymphoblastic leukemia (Ph+ ALL) in patients resistant or
intolerant to prior tyrosine kinase inhibitor therapy.
Ariad recently provided an update on the commercialization of
Iclusig in the US. The company said that during the first 12
weeks of Iclusig's launch in the US, there were more than 225
unique prescribers and nearly 200 unique accounts using the
About 65% of the prescribers are community based physicians
with the balance representing the academic setting. As the launch
progresses, usage by community based physicians is expected to
Meanwhile, Iclusig should gain approval in the EU in the
second quarter of 2013. In Mar 2013, the European Medicines
Agency's (EMA) Committee for Human Medicinal Products (CHMP) had
voted in favor of approving Iclusig.
Ariad intends to submit regulatory applications for Iclusig in
Canada, Switzerland and Australia in the third quarter of
We note that Ariad is evaluating Iclusig in additional
studies. Iclusig is currently in the phase III EPIC study
(Evaluation of Ponatinib versus Imatinib in Chronic Myeloid
Leukemia), with interim results due in mid-2014.
Ariad currently carries a Zacks Rank #3 (Hold). We expect
investor focus to remain on the commercialization of Iclusig.
Currently, companies like
) look more attractive. While QLT Inc. and UCB are Zacks Rank #1
(Strong Buy) stocks, Biodel is a Zacks Rank #2 (Buy) stock.
ARIAD PHARMA (ARIA): Free Stock Analysis
BIODEL INC (BIOD): Free Stock Analysis Report
QLT INC (QLTI): Free Stock Analysis Report
UCB SA (UCBJF): Get Free Report
To read this article on Zacks.com click here.