Ariad hunkers down
Iclusig is back in US
Drugmaker Ariad Pharmaceuticals is hunkering down. Days after announcing that it was laying off 40% of its staff, the company said during its Tuesday earnings call that it was streamlining its operations so costs will be 35% lower in 2014 than 2013.
The company expects the plan will keep the lights on until the middle of 2015, as it hammers out issues around the safety of its cancer drug Iclusig, which is no longer being marketed or distributed in the US after the FDA asked the company to back off. The drug is still available under an investigational new drug application, known as an IND.
Execs called the plan a worst-case scenario that assumes no revenues from Iclusig.
The European Medicines Agency is reviewing the drug, but has not stopped its distribution. Ariad said Tuesday that it still expects to launch in Japan and that feedback from the US is being taken into account as the drug continues to move forward.
The FDA asked the company to halt US distribution over concerns of adverse events. Ariad's CEO said at the time that the FDA made its decision based on the same information it used for its expedited approval in 2012.
Chief Medical Officer and Senior Vice President, Clinical R&D, Frank Haluska indicated that this is no longer the case. The executive told analysts Tuesday that the FDA had in fact changed how it assessed risk, a change he says the company discovered when the agency updated its safety notice late last month. Haluska said the regulator has now categorized all adverse events as serious, compared to last year, in which he said the regulator considered gradations of risk.
CEO Harvey Berger reiterated Tuesday that he expects the end result will be a label that uses more restrictive prescribing criteria.