ARIA

ARIAD Pharmaceuticals, Inc. (ARIA)

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ARIAD Pharmaceuticals, Inc. (ARIA)

Barclays Global Healthcare Conference

March 13, 2013 10:45 am ET

Executives

Harvey J. Berger - Principal Founder, Chairman of the Board, Chief Executive Officer, President and Chairman of Executive Committee

Analysts

Ying Huang - Barclays Capital, Research Division

Presentation

Ying Huang - Barclays Capital, Research Division

Okay. Good morning, everyone. I just want to thank everyone for joining us this morning. And my name is Ying Huang, I'm the U.S. biotech analyst here at Barclays. It's my pleasure to introduce our next presenting company, which is ARIAD Pharmaceuticals, and we're very pleased to have the CEO, Dr. Harvey Berger, with us. And we'll actually use the so-called fireside chat format. So with that, I guess I'll just kick off by asking Dr. Berger.

So obviously, in 2013, the focus of the company will be on the launch or commercialization of Iclusig. Right now, I think you're about 8 to 9 weeks into the launch following the FDA approval last December. Can you provide us with some insights into the launch trajectory so far? And what are the lessons you have learned? And what gives you the confidence that it will be a good, successful launch?

Harvey J. Berger

Sure. Thanks very much for the opportunity to be with you this morning and to give you sort of an update on where we are, both with Iclusig as well as our other products.

So far, the launch has been going right as we anticipated, right on track. We are tracking internally week-by-week utilization of Iclusig. And as we recently said on one of our -- on our last investor call, the utilization that we've seen has been across really all the lines of treatment, from patients who have received 1, 2 or 3 or in fact more prior tyrosine kinase inhibitors. Prior lines of therapy that -- Iclusig is being taken up well by the hematology/oncology community and, as best as we can tell, is really being prescribed very much, consistent with the label that -- in terms of breadth of the indication statement and the results of the PACE trial. So, so far, so good. And we expect the launch to continue in a strong and solid way going forward.

Ying Huang - Barclays Capital, Research Division

And then obviously, I think The Street was taken a little bit by surprise with the FDA label somehow. So I was wondering, do you think, in your commercialization, at least in the first 8 or 9 weeks, have you seen any concerns around the prescribing doctors around the label? Or no?

Harvey J. Berger

Well, I think you're referring to the warning...

Ying Huang - Barclays Capital, Research Division

The back warnings.

Harvey J. Berger

The warnings and precautions that were included. They were based among the treatment-emergent adverse events. As we anticipated in December, and now I think have seen over the last roughly 2 months that Iclusig has been available, that certainly, physicians take the warnings and precautions of Iclusig or other medicines into consideration. But that -- really, very much as we anticipated, the benefit/risk and the efficacy of Iclusig, as has been shown by the breadth of the label, the clarity of the responses and the -- really the clear visibility of the utilization of Iclusig in the -- thus far in clinical practice that, yes, physicians look at the warnings and precautions. But we've embraced the entire label as we've gone forward and met with physicians. And I think what really drives physicians' decisions on Iclusig, and certainly most cancer medicines, is, in our case, the strength of the efficacy data; the breadth of use in patients with a resistant/intolerant disease; responses in patients -- quite regularly, patients who have never really had any alternative options; the independence of the responses on whether or not patients have resistance mutants documented or not, which resistance mutants as well doesn't seem to matter, doesn't seem to matter whether it's one tyrosine kinase inhibitor or 3. So without question, the adoption of Iclusig is being driven, as we see it, by the strength of the efficacy data, the breadth of its utilization, certainly not -- minimizing that every medicine needs to be positioned, looking at both the efficacy data as well as the safety data. But certainly, for a medicine like Iclusig, the driver is very clearly the -- is the very robust efficacy data.

Ying Huang - Barclays Capital, Research Division

Okay, great. And then you just mentioned that you're seeing patients who have failed maybe 1, 2 or 3 prior therapies of TKI on the market already. I know it's still very early days for your launch, but can you say something around whether you're seeing a meaningful share of patients who have to stay on only 1 TKI therapy now, who are being put on Iclusig?

Harvey J. Berger

What we've seen thus far is use across all of the lines of prior therapy. I think 2 months into the launch is just way too early to try to put adjectives or descriptors on any of the subsets of the resistant and intolerant patient population. But I would say that -- I mean, there is no question, Iclusig is not being relegated to a last-line therapy. It's really being used across the entire spectrum of patients with a resistant/intolerant disease, CML, as well as Philadelphia-positive ALL. In the CML side of things, chronic phase, accelerated phase and blast phase, as best as we have access to the data. I mean, it's difficult to know exactly patient histories because of all the HIPAA rules and other things. We don't get as full access as obviously -- as you would in a clinical trial. But with the information that we get that allows reimbursement to take place readily, we certainly have very strong view -- insights across the entire spectrum of disease.

Read the rest of this transcript for free on seekingalpha.com