(Reuters) - Ariad Pharmaceuticals Inc will suspend sales of its blood cancer drug Iclusig, barely two weeks after the company stopped an ongoing trial of the drug due to safety concerns.
The company’s shares fell as much as 43 percent to a four-year low on Thursday.
Ariad, on a conference call, said there was a possibility that the U.S. Food and Drug Administration might ask for new trials for the drug that won an accelerated approval last December.
Iclusig was approved to treat two rare blood cancers, a type of chronic myeloid leukemia and a version of acute lymphoblastic leukemia.
An accelerated approval is granted based on promising data from early trials. The process still requires further studies to prove the drug is as effective as initially thought.
But the FDA earlier this month placed a partial hold on Iclusig’s late-stage trial after a number of patients taking the drug experienced blood clots and heart damage. The company later discontinued the trial.
Ariad had $351.9 million in cash, cash equivalents and marketable securities, as of June 30.
Iclusig, which was also being developed for lung cancer, gastrointestinal tumors and thyroid cancer, was expected to generate sales of about $821 million by 2018, according to Thomson Reuters data. Ariad reported net sales of $13.9 million for the drug for the quarter ended June 30.
The decision to suspend Iclusig sales was taken in response to a request by the FDA, Ariad said.
"At this time, FDA cannot identify a dose level or exposure duration that is safe," the agency said on its website. (link.reuters.com/hez34v)
The FDA also recommended patients currently taking Iclusig and not responding to it should immediately stop treatment and explore alternative options. Patients responding to Iclusig should be treated under a drug development setting as long as the FDA was investigating the safety issues.
Ariad said it was actively working with the FDA to resume marketing of the drug.
The company’s shares were down 37 percent at $2.49 in morning trade on the Nasdaq. They touched a low of $2.27 earlier in the session.
The stock was the second most traded on the exchange, with more than 37 million shares changing hands by 11 a.m. ET.
The shares have lost 77 percent of their value through Wednesday since the company announced the trial halt on October 9.
Reporting by Esha Dey in Bangalore; Editing by Sriraj Kalluvila and Ted Kerr