Ariad Pharmaceuticals Inc. (ARIA) reported second-quarter loss of 37 cents per share, wider than the year-ago loss of 31 cents per share but narrower than the Zacks Consensus Estimate of a loss of 40 cents per share.
Second-quarter revenues were $14 million, compared with $0.32 million in the year-ago quarter. Revenues surpassed the Zacks Consensus Estimate of $11 million.
Research and development expenses increased 3.2% year over year to $41 million. The increase was attributable to the company’s efforts toward further developing and manufacturing Iclusig and AP26113. Selling, general and administrative expenses increased 244% year over year to $42.1 million. The massive increase was primarily attributable to the expenses incurred by the company in launching Iclusig. The company now expects research and development expenses of $200-$208 million, and selling, general and administrative expenses of $152-$160 million for 2013.
By the end of the reported quarter, more than 610 patients in the U.S. were given Iclusig. Iclusig is approved for use in heavily pretreated patients, suffering from resistant and refractory chronic myeloid leukemia (:CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig generated $13.9 million of U.S. net sales in the quarter. Around 450 unique physician prescribers for Iclusig and around 360 unique accounts using Iclusig were noted at the end of the reported quarter. The company’s goal is to treat 1,000 – 1,100 patients with Iclusig by year end.
In Jul 2013, Iclusig was approved in Europe. Ariad expects to receive approval in Switzerland in the fourth quarter of the year. Meanwhile, Ariad has filed for regulatory approval in Canada and Australia.
Iclusig is currently in the phase III EPIC study, in which it is being compared to Novartis’s (NVS) Gleevec (imatinib) in patients with newly diagnosed CML. Ariad is presently enrolling patients for the study with interim data likely to come out in the third quarter of 2014. Iclusig is in another phase III study, SPIRIT 3, for which enrollment will start in the third quarter of 2013.
In Jun 2013, Ariad commenced an open-label, multicenter phase II trial of Iclusig in patients suffering from metastatic and/or unresectable gastrointestinal stromal tumors (:GIST). The study is evaluating Iclusig’s efficacy and safety in patients who have failed at least one tyrosine kinase inhibitor (:TKI) therapy.
Meanwhile, patient enrollment for the phase II part of the phase I/II study on AP26113 is ongoing for non-small cell lung cancer.
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