Ariad's Iclusig further restricted by EMA

Drugmaker Ariad ($ARIA) left its European operations untouched last month when it took an ax to its workforce after the FDA requested it pull its leukemia drug Iclusig off the market in the U.S. Regulators in the EU did not make the same request, but they also did not ignore the clotting risks that raised a red flag at the FDA. Now, the European Medicines Agency (EMA) has come out with guidelines that further restrict the market potential of the drug once believed headed for blockbuster sales.

The EMA said today that its Committee for Medicinal Products for Human Use (CHMP) is recommending doctors not use Iclusig on patients who have had a heart attack or stroke in the past, unless the potential benefits to them outweigh the risks. It also recommends that doctors fully weigh the cardiovascular risks of all patients before using the drug, make sure they have their blood pressure controlled and stop the drug immediately if there are any signs of blood clots.

The company put a positive spin on the news, pointing out that the EMA was continuing to let it sell the drug in Europe. Its shares did move up nearly 9% on the news in early trading, but they are down more than 80% since the FDA put a hold on a trial in October because of the blood-clotting risks.

It has been a sorry turn of events for a drug that 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.

But there were signs of trouble even then. The drug was approved with a black-box warning, and on the day of approval, investors drove the price of its shares down 20%. Already weakened, the company adopted a poison-pill provision this month to try to keep someone from swooping in and buying the company on the cheap as it tries to work its way out of its current situation. Reuters reported recently that a fund tied to activist investor Carl Icahn owns about 5% of its shares.

- here's the release