12:00 AM
Dec 24, 2012
 |  BioCentury  |  Finance

Iclusig black out

Next milestones needed to undo Ariad's haircut on Iclusig boxed warning

Ariad Pharmaceuticals Inc. has lost $568.3 million in market cap since FDA approved leukemia drug Iclusig ponatinib with an unexpected boxed warning for arterial thrombosis and liver toxicity. Buysiders and analysts think the sell-off was an overreaction, but expect the market to wait for sales numbers and additional data before moving back into the stock.

On Dec. 14, FDA granted accelerated approval for Iclusig to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) that is resistant to or intolerant of prior treatment with tyrosine kinase inhibitors.

Approval of the pan-BCR-ABL tyrosine kinase inhibitor came more than three months ahead of the March 27 PDUFA date. And the label is broader than the population in the pivotal Phase II PACE trial, which enrolled 449 patients who failed treatment with the tyrosine kinase inhibitors Sprycel dasatinib or Tasigna nilotinib or who had the T315I variant of BCR-ABL tyrosine kinase.

Iclusig's label provides for use after failure of any tyrosine kinase inhibitor, not just Sprycel or Tasigna.

The boxed warning was a surprise, however, and...

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