Ariad Pharmaceuticals' stock plunged yesterday on news that the Cambridge company was suspending sales of its leukemia drug Iclusig because of concerns that patients taking it could suffer life-threatening blood clots.
Shares dropped more than 44 percent to $2.20 on the Nasdaq stock exchange after federal regulators asked it to stop marketing the drug. Ariad first disclosed a higher rate of side effects related to blood clots Oct. 9.
"The company's actions have been taken in response to a request from the Food and Drug Administration yesterday afternoon," Ariad said in a statement. "Ariad believes that Iclusig is an important medicine for patients with resistant or intolerant Philadelphia-positive leukemias and is actively working with the FDA on actions to achieve the resumption of marketing Iclusig."
The FDA said nearly half of patients treated with the drug, also known as ponatinib, in an early-stage trial and nearly one in four patients in a mid-stage trial have experienced serious side effects, including "fatal and life-threatening heart attack, stroke, loss of blood flow to the extremities resulting in tissue death, and severe narrowing of blood vessels in the extremities, heart and brain requiring urgent surgical procedures to restore blood flow."
"At this time, FDA cannot identify a dose level or exposure duration that is safe," the agency said.
An Ariad spokesman declined to make chief executive Harvey J. Berger available for an interview.
In December 2012 — a year in which Ariad's stock nearly doubled in value as the drug moved toward approval — the FDA gave the company the OK three months ahead of schedule to sell Iclusig in the United States to allow patients access to what seemed a promising new treatment while additional studies were being conducted.
But in a note to investors yesterday, Citi Research analysts Jonathan Eckard, Yaron Werber and Joel Beatty said they saw a "tough road" ahead for Ariad and a "very limited future for Iclusig at best."
"While little clarity on the timing of reintroduction of the drug is available, we see the process taking at least several months," the analysts said, "and the ultimate outcome will be a highly restricted label and commercial opportunity."
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