Ariad returns Iclusig to market but with more restrictions and smaller patient pool

Ariad Pharmaceuticals ($ARIA) is back in the market with Iclusig. The FDA is allowing the Cambridge, MA-based company to again sell the leukemia drug, but with tighter restrictions to face. Ariad has a lot of ground to regain to return to its former glory.

While CEO Harvey Berger said the company is starting 2014 where it left off, that is not entirely accurate. Iclusig is now approved for a smaller patient population. The company also has post-marketing requirements including a trial testing other doses of the drug.

And as for the size of the company, he said it would add some sales reps, but not nearly the 160 that it let go in November after the FDA had it yank the drug from the market because of blood clot risks, Bloomberg reports. Those 160 represented 40% of the company's U.S. workforce, and Ariad expected to save about $26 million through 2014 with the cuts. At the time, it did not touch its EU sales group because it had not limited use of the drug. But since then, the EU has added tighter restrictions as well.

The company also saw its market cap plunge after questions first arose in the fall. Its shares were up as much as 31% to $7.25 in mid-morning trading, but that is off from about $18.25 a share in September.

The FDA is now allowing Iclusig to be used for adult patients with a mutation called T315I and for patients for whom no other tyrosine-kinase inhibitors are indicated. Previously, it could be for adult patients when that therapy didn't work or was intolerable. Under the old label, the company said 640 patients were taking the drug. The FDA has so far approved on a case-by-case basis 350 who would qualify.

It has been a rollercoaster ride for Ariad and Iclusig, a drug the FDA granted accelerated approval to less than a year ago, approving it to treat both patients with chronic myeloid leukemia who have stopped responding to other drugs and patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. The company quickly rolled the drug out, putting a $115,000-a-year price tag on it, and touted how the drug had been brought to market in 5 years, turning Ariad into a commercial oncology company in the process. Analysts believed there was a blockbuster in the making.

- here's the announcement
- more from Bloomberg

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