Ariad Pharmaceuticals (NASDAQ: ARIA ) reported third-quarter sales of its leukemia drug Iclusig, but no one was cheering the biotech on the 20% quarter-over-quarter growth. There were no "congrats on the great quarter" from analysts.
That's, of course, because Iclusig was pulled from the market after the quarter ended. It's hard to get excited about the past when the future is so uncertain. "Past performance is not an indication of future results" has never been truer.
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Getting Iclusig back on the U.S. market
Iclusig was pulled off the market because the Food and Drug Administration decided that the risk of blood clots wasn't worth the benefit of the drug in the population listed on the label.
The company believes there's a population where the benefit justifies the risk -- the patients have cancer, and are going to die if left untreated, after all.
Iclusig is currently approved if patients have failed Novaris' (NYSE: NVS ) Gleevec, or Bristol-Myers Squibb's (NYSE: BMY ) Sprycel. The change might be as simple as requiring patients to have taken Gleevec and Sprycel and any other drug. Pfizer's (NYSE: PFE ) Bosulif, for instance, is approved as a treatment of last resort for a related leukemia. Of course, that's not necessarily good news for Ariad; Iclusig was prescribed 2.5 times as often as Pfizer's Bosulif during the first 10 months of their respective launches.
The FDA has the final call on what the label will look like, and what kinds of restrictions are placed on who and how the drug can be prescribed. It will likely take many months to work out the details. If an advisory committee meeting needs to be called, it will take longer. If the FDA wants a new trial to define the risk in the proposed population, it could take years to get back on the market.
The situation is reminiscent of Elan and Biogen Idec's (NASDAQ: BIIB ) multiple sclerosis drug Tysabri, which was pulled from the market when patients began having brain infections. Elan and Biogen Idec eventually defined the risk, and the FDA allowed the drug back on the market with a patient registry to make sure patients understood the risk.
Keeping Iclusig on the EU market
The EU regulators, the Committee for Medicinal Products for Human Use, or CHMP, is scheduled to make a final ruling on what to do with Iclusig this month. An initial assessment by its Pharmacovigilance Risk Assessment Committee recommended that the drug stay on the market with increased monitoring for blood clots. If the CHMP follows the recommendations, Ariad will be able to continue selling Iclusig, although the warnings on the label will likely be heightened to include the cardiovascular risk.
How well Iclusig will sell in the EU remains to be seen. European countries that have centralized health-care systems tend to push back on paying high prices for treatments of last resort. Ariad's pivotal study didn't have a placebo control arm, so it isn't clear how long Iclusig might be extending patients' lives.
With sales in the EU likely to take awhile to ramp up, surviving until it can sell Iclusig in the U.S. again is Ariad's top priority. The company jettisoned 40% of its U.S. workforce to conserve cash, which will help reduce the cash its uses for operations by 35% next year. It's nearly $300 million nest egg should last to the middle of 2015.
Under all but the worst-case scenarios, that should be enough time to get Iclusig back on the market. Whether analysts will be cheering the sales figures depends on how restrictive the new label is.
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