ARIAD Pharmaceuticals, Inc. ARIA remains focused on the discovery, development and commercialization of breakthrough treatments for cancer. This year was a tough one for the pharma sector, which had to grapple with media and political focus on the high prices of drugs. Shares of ARIAD Pharma, however, surged 98.4% year to date and outperformed the Zacks classified Medical-Drugs industry that declined 25.4%.
The company has delivered positive earnings surprises in all of the last three quarters of 2016. Its loss estimates also narrowed 28.6% from 63 cents per share to 45 cents per share for 2017, over the last 60 days. Moreover, growth for ARIAD Pharma is expected to be 5.22% next year.
The company’s leukemia drug Iclusig, which was launched in Jan 2014 for the treatment of adult patients with refractory Ph+ ALL (Philadelphia-chromosome positive acute lymphoblastic) and CML (chronic myeloid leukemia), is performing well. Importantly, FDA’s full approval of Iclusig in November this year was a major positive for the company. In fact, this explains why ARIAD Pharma’s shares gained 34.9% since November compared with a 4.9% increase for the Medical-Drugs industry. Moreover, ARIAD Pharma is working on expanding Iclusig’s label, especially into earlier lines of treatment, which will expand the market significantly. Currently, Iclusig is in OPTIC dose-ranging study, the OPTIC-2L in second-line patients with chronic phase CML (compared to Gleevec) as well as the phase II PACE (Ponatinib Ph+ ALL and CML Evaluation) study. Also, ARIAD is looking to improve Iclusig’s safety profile through lower doses. The second-line indication, if approved, would more than double Iclusig’s existing market.
Meanwhile, ARIAD completed the rolling submission of New Drug Application (NDA) to FDA for its most advanced pipeline candidate, brigatinib, in November this year. It is indicated for treatment of patients with advanced malignancies, including anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC). ARIAD expects to launch the candidate in 2017. Additionally, FDA has granted Breakthrough Therapy status to brigatinib. Meanwhile, the EU submission for brigatinib is slated for the first quarter of 2017.
Iclusig faces intense competition from Novartis AG’ NVS Gleevec, Bristol-Myers Squibb Company’s BMY Sprycel and Pfizer’s Inc. PFE Bosulif. Nonetheless, team expansion, positive label updates, increasing clinical experience and patient retention programs should drive growth for Iclusig, going forward.