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Ariad's Iclusig in GIST Phase II Study

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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 (TKI) therapy.

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 mid 2014.

According to the American Cancer Society, about 4,000-5,000 GIST cases occur in the US every year. Currently approved treatments include Pfizer Inc.’s (PFE - Free Report) Sutent and Novartis’ (NVS - Free Report) 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 (JAZZ - Free Report) looks well positioned with a Zacks Rank # 1 (Strong Buy).

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