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Ariad tanks as Iclusig trial is halted on safety grounds

Shares fall after leukaemia patients develop blood clots

Ariad Iclusig ponatinib 

Investors continued to bail out of Ariad Pharmaceuticals after it was forced to terminate a pivotal trial of its leukaemia drug Iclusig because some patients developed blood clots.

The EPIC trial involved patients with newly-diagnosed chronic myeloid leukaemia (CML) and was stopped "in the interest of patient safety", said the company in a statement. Ariad suspended enrolment into the trial earlier this month.

Iclusig (ponatinib) was granted accelerated approval by the Food and Drug Administration (FDA) in December to treat adults diagnosed with chronic phase, accelerated phase, or blast phase CML or Philadelphia chromosome-positive acute lymphoblastic leukaemia (ALL), who are no longer benefiting from previous treatment or who did not tolerate other treatment.

Shares in the company have fallen more than 85 per cent late since early October, when the FDA announced that it was "investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels in patients taking the leukemia chemotherapy".

There was a 40 per cent slump late last week on news of the EPIC termination amid fears that Iclusig might be withdrawn from sale in the US. It was also launched in the EU earlier this year and was scheduled for launch in Japan in 2014.

The stock has started to claw back a little this week, however, rising a little over 10 per cent as speculative investors gambled on the chance that the product would remain on the market (albeit with more restrictive labelling) and - with several other drugs in the pipeline and $300m in cash - that Ariad still has potential in the long-term.

Ariad's most advanced candidate after Iclusig is AP26113, in phase III testing for ALK-positive non-small cell lung cancer (NSCLC) patients who are resistant to Pfizer's Xalkori (crizotinib).

Iclusig achieved sales of around $20m in the first half of this year, during which time the company posted losses of more than $130m.

Much of Iclusig's peak sales potential - once thought to be upwards of $1bn - was thought to lie in an extension of its uses into first-line use in CML, as well as other potential indications such as gastrointestinal stromal tumours (GIST), medullary thyroid cancer and NSCLC.

Analysts at Jefferies now believe the company's peak sales potential is probably in the $380m-$500m range.

Article by
Phil Taylor

22nd October 2013

From: Research, Regulatory



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