Iclusig Re-launch Immenent; ARIA Outlines
Next Steps for Clinical Strategy
Credit Suisse / Jan 15, 2014
[Posted for background information. Even though brokerage report is only
two weeks old it seems ancient given all the recent developments. - A]
Iclusig will be made available again in the US later this month following the
FDA's approval of the new label and the risk evaluation and mitigation strategy
(REMS). ARIA has plans to clarify the dose/safety relationship of the drug and
to push into new indications. We remain cautious pending new launch metrics,
and expect ARIA will need to raise additional capital in 2014.
¦ EPIC data to be presented at 2014 ASCO meeting. ARIA expects to
present available clinical data for the Phase III EPIC study in front-line CML
patients at the upcoming ASCO meeting (May 30-June 3). The presentation
will likely focus on the safety analyses and will include data from
approximately 300 patients. This is the first safety analysis with an active
comparator (Gleevec), which could potentially have commercial implications.
¦ ARIA still has aspirations for the front line CML indication. Management
indicated that it is still interested in pursuing the front-line setting. This will be
gated by the upcoming dose exploration study expected to recommend an
optimal dose for front line patients. Even if ARIA started a new front line trial
in 2015, it will likely take two to three years to complete, by our estimates.
¦ GIST indication likely to become a key focus. ARIA reported the first
anecdotal data for Iclusig in GIST. This study was nearly fully enrolled once
the partial clinical hold was put in place, and ARIA expects to present initial
data from the GIST trial at ASCO. Recall that approximately $1.4B of the
2012 Gleevec annual sales were largely attributable to its GIST indication,
suggesting this is a large marketing opportunity.
¦ ARIA provides outline of registrational AP26113 trial
ARIA will initiate a pivotal trial of AP26113 in ALK+ NSCLC patients that are Xalkori
resistant in Q1:14. The trial will enroll approximately 220 patients, and will include patients
with brain metastases. All patients will be dosed with 90mg QD for one week, then patients
will be randomized 1:1 to receive either a 90mg or 180mg dose. The primary endpoint is
ORR, and CNS response will also be measured. Twenty patients in the Phase I
exploratory study have been dosed at 90mg for one week and then 180mg thereafter, and
none of these patients reported developed the pulmonary syndrome observed in earlier
dose cohorts.
¦ Still strong interest in investigator sponsored trials of Iclusig
ARIA indicated that nine ISTs are expected to start in 2014. The diseases to be examined
include: (1) Elderly Ph+ ALL, (2) Blast Phase CML, (3) AML, (4) endometrial cancer, (5)
FGFR mutant cancers or other cancers with mutations in other ponatinib targets, and (6)
bile duct carcinoma. We believe this is a positive sign for the Iclusig franchise, as it
suggests that physicians are not overly concerned about the side effect profile and view
the risk/benefit reward favorably for certain cancer types.
¦ ARIA increased Iclusig price 8.0%
ARIA increased the price of Iclusig by 8.0% late last December. Other companies
marketing a TKI also took increases in the past several months. Iclusig is still priced at
premium to other TKIs.
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