Ariad faces fresh woe as EMA takes a harder look at Iclusig

Ariad Pharmaceuticals ($ARIA) seemed to dodge a bullet last month when the European Medicines Agency chose not to follow its U.S. counterpart, letting the troubled Iclusig stay on the market. Now, the regulator is reopening the books on Ariad's cancer drug, reviving concerns about the company's sole product and sending its shares down about 10%.

The EMA's Pharmacovigilance Risk Assessment Committee has kicked off an in-depth review of the clotting risks tied to Iclusig, a leukemia drug yanked off the U.S. market over alarming thrombosis rates. In November, Europe's Committee for Medicinal Products for Human Use ruled that Iclusig could stay on European shelves but recommended against using it on patients with heart attacks or strokes in their pasts, but regulators now believe they need to revisit the issue and "assess the need for further changes to how the medicine is used."

That's unlikely to spell good news for the reeling Ariad, which is in the midst of laying off 160 employees from its U.S. operation to save $26 million by year's end. Those cuts will spare Ariad's whole European workforce, but the company may not be able to keep its operation in tact for long if overseas regulators come down hard on Iclusig.

Ariad's shares fell as low as $4.10 on Friday, and the company has tanked nearly 90% since the Iclusig disaster began in early October. It all started with an FDA-imposed hold on a late-stage study of the drug, leading Ariad to cancel the trial due to a spike in clot development among patients in the treatment arm. The company eventually halted sales at the FDA's request later that month, adopting a poison pill plan to ward off unwanted takeovers while watching more than $3 billion in market value wash away.

Management has hardly given up on Iclusig, and the company has said it will work with the FDA to get the leukemia treatment back on sale as soon as possible. However, pointing to the history of drugs pulled from the market, analysts figure that process could take well more than a year, and Leerink Swann's Howard Liang believes there's a decent chance Iclusig has made its last dime in the U.S.

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