Shire Contemplates Off-Label Use of Intuniv, Vyvanse

The FDA's approval of Intuniv brings to four the number of drugs for ADHD currently marketed by Shire. (The other three are Adderall XR, Vyvanse and the Daytrana patch.) There are about 11 drugs on the market for ADHD.

Shire's stock is up a little, but that is more about the company's entry into Genzyme's monopoly on Gaucher disease drugs than any market enthusiasm for a 12th ADHD pill. In fact, Shire got more questions about the Genzyme fiasco on its last conference call than it did about Intuniv.

As such, Intuniv is yet another me-too drug. Nonetheless, Shire told investors on that call it would give Intuniv a "premium" price despite the competition. So how does Shire expect this relatively expensive, me-too drug to compete in a sea riddled with generics? Management hinted that they expected Intuniv might be used off-label, perhaps for oppositional-defiant disorder:

Corey Davis, Natixis Bleichroeder: ... on INTUNIV, I didn't think you were going to get ODD in the label, but from the comments, Mike, you made on the slide, it sounds like that's how you're going to be positioning it. A) Am I correct it's not going to be in the label, and B), if so how are you going to be able to talk about ODD?

Mike Cola, President, Specialty Pharmaceuticals: Yes, I think you are referring to Study 307. I hope we've been fairly clear about the use of the term ODD in the past because I think that is not something that the agency has been willing to entertain going in the label. It's really viewed as sort of specific indication and part of the overall disease of ADHD. The language that we will be using promotionally will be around is difficult to treat patients that have disruptive behaviors. And I think that has really been a better marketing tool than what we've been able to get back from our physicians as far as positioning the patient type we're looking for. These oppositional and disruptive behaviors. So there is no DSM-IV or ICD-9 code around ODD. The agency has been pretty clear with us about that. But I think we will be able to use Study 307 in promotion.

I'm not suggesting that Shire plans to promote Intuniv off-label for ODD. But Cola's remarks sure seem to suggest that management is at least thinking that might happen. In fact, they put out a press release talking about "oppositional symptoms" in May. It's a similar situation on Intuniv:

David Amsellem, Piper Jaffray: Okay. And then just quickly on VYVANSE market expansion studies. Are you looking at psychiatric indications such as refractory depression or bipolar depression? Can you comment on the extent of off-label usage of long-acting stimulants in these settings?

... Mike Cola: ... These agents, as you know, have been used off-label for years and years around mood cognition and metabolic disease, and those are the areas that we're going to focusing on. There will be another group of these indication areas that we will talk about probably at the end of the year.

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