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Shire's CEO Discusses Q1 2012 Results - Earnings Call Transcript

We recently announced the commencement of head-to-head trial of VYVANSE versus Concerta. If you remember, when Jeff talked about European filing, he referred to that having a reference on in one of the studies. That came out, if you remember, with a very favorable comparison. And on the base of that, we feel very empowered now to conduct a full head-to-head study versus Concerta. You may ask why we're doing that at this stage of the product's life cycle. Simply put, it's to demonstrate to payors around the world as we contemplate the rolling out of VYVANSE on a global basis. But this is by far in a way, the best product in the class and offers best value to both patients and payors all over the world.

We're also ongoing with our enrollment in our major depressive disorder study, the first lead of our new uses of VYVANSE programs. And we also, today, have reported headline data from -- positive findings on headline data from a new Phase II study in binge eating disorder, and Jeff will be commenting on that in more detail later in his presentation.

Turning to INTUNIV. Again, very significant increase, up 54% in volume since alone in scripts versus the same period last year. Market share really being driven by new consumer marketing campaigns and also the approval early last year of the extension of the label to adjunctive therapy in combination with the stimulant. We're also remember enrolling INTUNIV in a Phase III program in Europe, and it's again our intent to bring that product to Europe a little bit behind VYVANSE. But we will end up, we hope, with the 2 leading products in ADHD appearing in Europe in the next few years.

Now moving to what's becoming really an embryonic but emerging new business area franchise for Shire, and that's hematology. This quarter, you'll have seen us make the acquisition of a product from FerroKin Biosciences, FBS0701. It's in Phase II and again, Jeff will be giving a bit more detail as to what we intend to do with that product mix.

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