What's Ahead for Ariad?

Shares of Ariad Pharmaceuticals (NASDAQ: ARIA  ) dropped around 14% when its first drug Iclusig received an expected Food and Drug Administration approval -- with unexpected warning label requirements. Iclusig was the highlight of the company's JPMorgan Healthcare Conference presentation last week, mainly because there's not a lot else happening.

With that large catalyst behind them, and a limited field of prospective candidates, what's in store for Ariad?

Label expansion
Iclusig treats chronic myeloid leukemia, or CML, and a chromosomally abnormal form of acute lymphoblastic leukemia, or ALL. The drug's approval specifically covers patients who don't respond to the front-line treatments. Investors reacted negatively to an FDA-assigned warning label pertaining to blood clot and liver toxicity risks.

Patients typically start with Novartis' (NYSE: NVS  )  Gleevec. The drug's leading position helped earn $4.7 billion worldwide last year. If Gleevec doesn't work, there's Novartis' Tasigna or Bristol-Myers Squibb's Sprycel. Iclusig comes next. This funnel-down approach narrows the drug's market potential along the way.

That's why Ariad initiated trials for a potential label expansion. A phase 3 trial under way compares Iclusig's efficacy to Gleevec in patients newly diagnosed with CML. The trial should report in mid-2014 and could lead to Iclusig's approval for all CML and ALL patients, not just the treatment-resistant subset.

Release battle
For now, Ariad has to take Iclusig to market with the narrower label. The company says the commercialization structure is already in place to launch the drug domestically. Iclusig won't become available in Europe until the second half of the year, and Ariad plans to have that structure in place by July 1.

But Ariad will have company as the U.S. leukemia market grew more crowded just in the past year. Talon's Marquibo received approval for ALL. Pfizer's Bosulif and Teva's Synribo were approved for CML.

The rest of the pipeline
The only other drug to merit a mention at the JPMorgan conference was non-small-lung cancer treatment AP26113. And that mention amounted to a sentence on the company's hopes to initiate at least one pivotal trial this year.

Initial clinical results from September showed an improvement in advanced tumors that hadn't responded to previous treatments. But it will be quite some time before AP26113 produces any results worthy of investor reaction.

Ariad partnered with Merck (NYSE: MRK  ) for the cancer drug ridaforolimus. The FDA turned down ridaforolimus last summer and requested further trials to determine the drug's safety and efficacy. There's no word yet on when or if those trials will happen.

Bringing up the rear is AP1903 with two phase 1 studies for prostate cancer and the niche graft-versus-host disease, or GHVD, which is a complication from stem cell or bone marrow transplant. Current GHVD treatments include prednisone and immunosuppressants.

Foolish bottom line
I would hold off on Ariad. There aren't any significant catalysts on the horizon. Iclusig will launch next year and start to show its performance capabilities. Label expansion trial results next year could provide the next notable market reaction.

Want to know more about one of Ariad's pipeline partners? For nearly 100 years, Merck's cutting-edge research has led to a number of medical breakthroughs. Today, however, this pharma stalwart is staring down a steep patent cliff and facing generic competition for its top-selling drug. Will Merck crumble under its own weight, or will it continue to pay dividends to investors for another century? To find out if this pharma giant has the stamina to keep its Bunsen burners alight, grab your copy of our brand new premium research report today. Our senior biotech analyst Brian Orelli, Ph.D., walks you through both the opportunities and threats facing Merck, and the report comes with a full 12 months of updates. Claim your copy now by clicking here.


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