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The Most Important Number for This Drug Launch

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ARIAD Pharmaceuticals (NASDAQ: ARIA  ) gave investors a closer look at how the launch of its leukemia drug Iclusig is going when it released second-quarter earnings yesterday.

There were plenty of numbers spouted in the press release and conference call to give investors confidence that the drug launch is on track.

  • Sales of Iclusig increased to nearly $14 million, more than doubling the $6.4 million in the first quarter.
  • A little over 600 patients have taken Iclusig, putting ARIAD on pace to treat between 1,000 and 1,100 patients with Iclusig by the end of the first year on the market in the U.S. 
  • Through the first six months of the launch, prescriptions for Iclusig are 40% higher than where Novartis' (NYSE: NVS  ) leukemia drug Tasigna was at the same point in its launch.

The most important thing
Those are all great indicators, but here's the number I think investors should be paying attention to most:

  • Of patients treated in the second quarter, 40% had only failed one prior tyrosine kinase inhibitor before being treated with Iclusig. That's up from 25% seen in the first quarter.

Right now, Iclusig is only approved for patients who have failed a tyrosine kinase inhibitor, such as Bristol-Myers Squibb's (NYSE: BMY  ) Sprycel and Novartis' Gleevec and Tasigna. Doctors willing to prescribe the drug as early as possible -- as opposed to a treatment of last resort -- is good news for future sales.

To become a blockbuster, Iclusig needs to move into a first-line setting, but the Food and Drug Administration won't approve it for that indication without data from a clinical trial, called Epic, testing Iclusig against Gleevec in newly diagnosed CML patients.

Assuming that ARIAD hits its goal of enrolling the trial by the end of the year, we would get an interim peek at the data in the third quarter of next year. If the clinical trial is a success and doctors are already comfortable with prescribing Iclusig, we could see considerable off-label use in newly diagnosed patients even before the FDA signs off on the expanded patient population.

A bonus number
Here's one more number to suggest that the launch will continue grow.

  • The number of prescribers doubled from the first quarter to the second quarter.

In general, it's a lot easier for salespeople to get a doctor to prescribe more of a drug that they've already prescribed -- assuming it's meeting their expectations -- than it is to get a doctor to start prescribing a drug.

Early in a launch, I'd much rather see a drug double sales by doubling a prescriber base than by the same prescribers doubling their prescriptions because eventually those prescribers are going to run out of patients to prescribe to.

Competing with the big boys
Let's face it, $14 million is still a relatively small sales figure. At that run rate, ARIAD is being valued at 62 times annual sales. 62!

To justify its valuation, ARIAD has to take sales away from some of the big boys. There's certainly plenty to go around. Bristol-Myers sold $312 million worth of Sprycel worldwide in the second quarter, up 28% year over year. Novartis' Gleevec and Tasigna combined for $1.5 billion in sales. Gleevec is the big boy, but Tasigna is no slouch with sales of $315 million in the second quarter.

A launch in the EU will help ARIAD drive sales higher, but investors should be focused on the first-line indication. We'll have to wait for data from the Epic trial, but I think doctors' use of Iclusig as a second-line treatment -- as opposed to third or fourth -- is a good sign that they think highly of the drug and anecdotal evidence that the Epic trial has a high likelihood of succeeding.

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