Question-and-Answer Session
Operator
Thank you. (Operator Instructions) Your first question comes from the line of Adam Greene with JP Morgan. Please proceed.
Adam Greene-J P Morgan
Thanks, good morning, happy Valentines Day everyone. Two questions, one I was wondering if you have any thoughts following the Zyprexa Depot panel meeting last week, any take away from that relative to your development and then secondly any update on the Hatch-Waxman action patent registration for Fiapta??
Mihales Polymeropoulos
Thank you, Adam and happy Valentines Day to you.
Adam Greene-J P Morgan
Thanks.
Mihales Polymeropoulos
The psychopharmacology advisory committee meeting on Zpyrexa Depot formulation was convened on February 6, in particular around the question on the relative safety and benefits ratio for the approval of this four week injectable formulation. Two key messages out of the advisory committee on the conviction by the experts in the field and the FDA, that there remains a significant mass medical need in schizophrenia and second, very interesting, is that not only a very good reason is there, but the need for long term injectables and I wanted to remind you that
Iloperidone has a safety profile and our ongoing efforts long before this injectable formulation will make it a very formidable competitor, in addition to psychiatrists’ choices. Your second question had to do on Hatch-Waxman. This is the customary expansion that adds to the NCA pocket life, you only apply that at the time of approval. And just to remind everybody of the time line, the NCE for Iloperidone is through the end of 2001 and therefore with the expectation of the full Hatch Waxman extension of five years, the NCE would be extended to the end of 2016.
Adam Greene-J P Morgan
Thanks.
Operator
Your next question comes from the line of Corey Davis with Natexis. Please proceed.
Corey Davis-Natexis Bleichroeder
Thanks very much. Mihales, excuse my voice, is the primary endpoint for the VEC-162 study at five weeks or is it some measure over the whole period of time?
Mihales Polymeropoulos
What typically is done is you declare as a primary endpoint, the first week data and then you have to subsequent endpoint in three weeks time and this is exactly how all the drugs in the clinic consumer have been approved.
Corey Davis-Natexis Bleichroeder
So patients are at home for most of the study but just go into the sleep lab for the objective measures once every week, is that correct?
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