CAMBRIDGE, Mass. (
) -- The nettlesome issue of
tied to Ariad Pharmaceutical's
leukemia drug Iclusig
was raised again Wednesday in a small survey of oncologists conducted by Favus Insitutional Research.
Ariad shares fell 4.1% on Wednesday to $16.76.
The more we learn about Iclusig, the less it appears to be a frontline CML drug. As the number of cases of liver toxicity, pancreatitis, abdominal pain, severe acute hypertension, heart attack, stroke, TIA, digital ischemia, and gastrointestinal perforation rise, investors' faith in Iclusig will fall, and so will the price of ARIA shares. Iclusig has a very small role to play in heavily pre-treated CML patients with the T315I mutation (extremely rare); as time goes on, that observation is becoming obvious. Don't be the last to know...
Favus surveyed 13 oncologists who have treated 77 patients with Iclusig since the FDA approval in December. Thirty-nine of the patients, or just over half, transferred from Ariad's pre-approval, expanded access program (EAP.) Another 10 patients (13%) have already discontinued Iclusig. The doctors surveyed told Favus that Iclusig is being used primarily in the small subgroup of CML patients with the T315I mutation, contradicting Ariad's claims that the drug is being more widely used.
BMO Capital Markets analyst Jim Birchenough came to Ariad's defense in a note criticial of Favus' methodology:
We would remind investors that patients enrolled in the Iclusig expanded access program (EAP) represent the sickest patient population, with a disproportionately high group of patients with blast phase (BP) or accelerated phase (AP) disease, only 40% of patients with chronic phase (CP) disease and at highest risk of imminent death, warranting EAP use of Iclusig ahead of approval. We also believe that the Iclusig EAP selected for patients with T315i mutation and is not representative of the labeled indication or expected broader commercial use. Indeed, expert feedback, and that from ARIA management over the last few days, suggests broad use of Iclusig across lines of therapy and independent of mutation status."
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Bosulif are the most recently approved drugs to treat CML and compete against
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Gleevec and Tasigna as well as
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-- Reported by Adam Feuerstein in Boston.