Welcome back, Ariad: Iclusig returns after a cold winter

Last year, Ariad Pharmaceuticals ($ARIA) watched more than $2.5 billion melt off its market cap when the cancer-fighting Iclusig began a downward spiral that would eventually remove it from the market. But now begins the rebuilding project, as the Cambridge, MA, drugmaker has relaunched its sole product with a lot of ground to make up.

The drug is now indicated for a smaller group of leukemia patients than before, and it carries a serious boxed warning about the risk of clotting and heart failure that got it pulled from shelves in the fall. But it is for sale, and that puts Ariad in a better place than many predicted at its nadir.

"We are back on track," CEO Harvey Berger told Bloomberg last month. "We'll enter 2014 largely where we were as we started off the fall in September."

Of course, that's not entirely the case. Losing more than half of its value forced Ariad to considerably thin its ranks, laying off 40% of its U.S. workforce--or 160 employees--in an effort to save $26 million. Now the company plans to gradually ramp up stateside sales with the help of specialty pharmacy Biologics, Inc., first looking to transition the case-by-case patients who were still using the drug during its marketing hiatus.

And the company has a long way to go on the R&D side. When the storm over Iclusig began, Ariad was in the process of testing the drug in a broader population, but an FDA-imposed clinical hold led the company to discontinue a Phase III study on patients with newly diagnosed chronic myeloid leukemia and put the brakes on a fleet of Phase II studies designed to expand the drug's market. Berger has said that Ariad is yet to decide just how to move forward with its paused programs.

Still, the biotech is undeniably sitting prettier than it was just two months ago, and its next big test will come when Q1 sales figures roll in.

- read the announcement

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.