Ariad Pharmaceuticals, Inc.
) recently announced the commencement of an open-label,
multicenter phase II trial of Iclusig (ponatinib) in patients
suffering from metastatic and/or unresectable gastrointestinal
stromal tumors (GIST).
The study will evaluate Iclusig's efficacy and safety in
patients who have failed at least one tyrosine kinase inhibitor
Iclusig, a TKI which was launched in Jan 2013, is currently
marketed in the US by Ariad for treating adults suffering from
chronic, accelerated or blast phase chronic myeloid leukemia, and
Philadelphia chromosome-positive acute lymphoblastic leukemia,
who are resistant or intolerant to TKI therapy.
Ariad recorded Iclusig sales of $6.4 million in the first
quarter of 2013. The company is currently looking to gain
approval for Iclusig in the EU. Ariad received a positive opinion
for Iclusig from the Committee for Human Medicinal Products
(CHMP) in Mar 2013 - we believe approval will come shortly. Ariad
expects to launch Iclusig in the EU by Jul 1, 2013.
While Ariad has submitted a marketing application in
Switzerland, the company anticipates regulatory submissions in
Canada and Australia in the third quarter of 2013 and in Japan in
According to the American Cancer Society, about 4,000-5,000
GIST cases occur in the US every year. Currently approved
) Sutent and
) Gleevec among others. Earlier this year, Stivarga gained FDA
approval for GIST.
Ariad currently carries a Zacks Rank # 3 (Hold). At present,
Jazz Pharmaceuticals Public Limited Company
) looks well positioned with a Zacks Rank # 1 (Strong Buy).
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