ARIAD Announces Changes in the Clinical Development Program of Iclusig

(NASDAQ: ARIA) today announced results of its review of updated clinical data from the pivotal PACE trial of Iclusig® (ponatinib) and actions that it is taking following consultations with the U.S. Food and Drug Administration (FDA).

With a median follow up of 24 months, serious arterial thrombosis occurred in 11.8% of Iclusig-treated patients: cardiovascular events 6.2%, cerebrovascular events 4.0% and peripheral vascular events 3.6% (some patients had more than one type of event).

This compares to 8.0% after 11 months of follow up reflected in the current U.S. prescribing information.

At 24 months, serious venous occlusion occurred in 2.9% of Iclusig-treated patients, compared to 2.2% in the current U.S. prescribing information.

The incidence rate of the arterial thrombotic events when normalized to duration of treatment exposure has not increased (10.0 events/100 patient-years in the original analysis and 9.6 events/100 patient-years in the current analysis).

Non-serious and serious arterial and venous adverse events combined occurred in approximately 20% of Iclusig-treated patients.

The Company is implementing the following actions in its Iclusig clinical development program:

http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=1...

--------------------------------------------------------------------------------------------------------------------------

Ariad's Nasty Surprise Gives The Sellside Pause For Thought
Oct 9 2013, 15:35

"............Yesterday Ariad's market cap had stood at a remarkable $3.1bn, basically on the strength of Iclusig. The drug, a BCR-ABL tyrosine kinase inhibitor, had been approved last December for chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia in patients who have failed on an earlier tyrosine kinase inhibitor.

But the Ariad bull case depended on expansion of Iclusig's label to first-line patients, and this comprised a chunk of the drug's forecast 2018 revenues of $760m.

Cardiac problems

Still, the warning signs were there. Indeed, at the time of approval the FDA called for a black box warning of arterial thrombosis and liver toxicity seen in ponatinib's Pace trial, and rumbling fears caused Ariad's stock to lose 32% since its October 2012 peak even before today's unpleasant setback.

The FDA hold was announced after both the US and European agencies conducted a risk analysis of ongoing studies, in particular the Pace trial. After 24 months follow-up in Pace, cardiac problems with Iclusig have not only continued, but they have increased.

Serious arterial thrombosis occurred in 11.8% of Iclusig-treated patients - up from the 8.0% after 11 months reflected in current prescribing information - while serious venous occlusion rose from 2.2% to 2.9%.

As such, Ariad said it would stop enrollment into all studies, though it went to some lengths to stress that it viewed the FDA hold as "temporary." Clinicaltrials.gov lists 12 active studies, 10 of which are actively recruiting.

Right now Ariad's only hope seems to be to modify trials, reducing the Iclusig dose to cut adverse events and hope that a sufficient therapeutic window remains. It claims to have evidence of continued efficacy at lower doses, and insists that the first-line indication is still worth investing in.
........."

Read full article here:
http://seekingalpha.com/article/1737272-ariads-nasty-surprise-gives-the-...