Ariad hunkers down

Share this article:
Iclusig is back in US
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.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Channel

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...