Question-and-Answer Session
Operator
(Operator Instructions)
Our first question comes from Cory Kasimov from JP Morgan.
Cory Kasimov - JP Morgan
Great. Good afternoon, everyone.
Jim Frates
Hi, Cory.
Cory Kasimov - JP Morgan
I guess starting with CONSTA, I'd be interested in just getting your reaction to yesterday's FDA advisory committee meeting for Zyprexa Depot?
David Broecker
Cory, this is David, great question. I don't know if you sat through and watched the whole thing. I was only able to kind of catch the tail end.
Cory Kasimov - JP Morgan
Yeah, unfortunately I did.
David Broecker
We thought it was fascinating. And I think the big takeaway for us is data matters. We didn't really know a lot about Zyprexa Depot going into the advisory panel, and obviously there was some lively discussion about what it looks like.
I think the other thing is the recognition that not all long-acting antipsychotics are going to be the same in this marketplace. So it's going to be very interesting, I think, to see what happens at the FDA, particularly around the label for this product going forward.
Cory Kasimov - JP Morgan
Okay. And then, last question with CONSTA is are you aware of Lilly's or J&J for that matters with regards to palmitate with their strategy for ex-US regulatory filings?
David Broecker
At this point what we've been told or what we know is that it hasn't bee filed, palmitate hasn't been filed in Europe. And we understand that there were some additional requirements that the European regulatory agencies wanted to see. But that's kind of all we know at this point.
Cory Kasimov - JP Morgan
Okay. And then one question, if I might, on exenatide once weekly. There is still discussion, obviously, out there as you are well aware that the FDA may not require a bioequivalence study. Can you discuss the precedent there as well as your experience with this matter, especially as it relates to CONSTA and VIVITROL?
David Broecker
Yeah, we can comment on that. For the specifics of interaction with the FDA around once weekly exenatide, I would just continue to refer people back to Amylin since they are the ultimate NDA holder on this. And I know that they are planning to provide update that they have more information and insight into this as we go forward.
But as it relates to some of the other programs, as you mentioned, we've got experience doing this a couple of times. With RISPERDAL CONSTA we actually didn't have to go through an elaborate comparability plan because we supplied material for the clinical studies out of the commercial scale equipment. So there was no need to do any sort of bridging type of work to show comparability there.
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