Ariad expects to complete enrollment by the end of the year in a study comparing Iclusig to Gleevec in first-line CML patients. The company believes positive results will help convince doctors to use Iclusig with newly diagnosed CML patients. Ariad shorts, including the aforementioned fund manager, believe this study will fail and may even be stopped early because Inclusig's safety and tolerability will be significantly worse than Gleevec.
On Wednesday, BMO Capital Markets analyst Jim Birchenough reiterated his outperform rating on Ariad and defended the company's outlook following a conversation with CEO Harvey Berger. Here's what Birchenough told his clients:
We had the opportunity to talk with Ariad's CEO Dr. Harvey Berger late yesterday to review recent concerns regarding IMS prescription data for ICLUSIG, breadth of proposed ICLUSIG labeling in the EU, and expectations for ALK/EGFR inhibitor AP26113 in NSCLC. Importantly, while the shares have been under pressure on this week's IMS TRX data, Dr. Berger highlighted good visibility on ICLUSIG daily data to the patient level, confidence in continued launch momentum, and breadth of ICLUSIG use across community and academic centers, by line of therapy and independent of mutation status. Dr. Berger acknowledged that the EU indication for 2nd -line ICLUSIG use after 2nd -generation TKI's was narrower than in the US, but highlighted 40% of front-line EU patients treated with 2nd -generation TKI's. Finally, with additional focus on ALK/EGFR inhibitor AP26113, Dr. Berger highlighted activity in brain metastases as key for favorable positioning in ALK+ patients where 50% of XALKORI failures have brain metastases, and importantly confidence in a similarly deliberate process of dose optimization to achieve blood levels that should consistently inhibit EGFR mutations in patients selected for proximal Tarceva failure in the phase 2 expansion study.
-- Reported by Adam Feuerstein in Boston.