Neurocrine Biosciences (NBIX) Message Board

To: DewDiligence_on_SI who wrote (1817)	1/18/2012 10:58:06 AM
From: Biotech Jim	1 Recommendation Read Replies (1) of 1826

Not much detail on Elagolix via the spoken word. More on the VMAT2 program. Here is a slide summary on the Elagolix ongoing activities: • Finalizing Phase III protocol for endometriosis though an SPA following a very productive series of Type C meetings with FDA » Endpoints – non-menstrual pelvic pain and dysmenorrhea » Statistical Methods – responder analysis » Trial Design – Two trials, placebo controlled, six-months in duration, safety extension to one year » Site qualification ongoing No milestones expected from ABT this year, and the Ph2 uterine fibroids study will be reported on later in 2012. The Ph3 Elagolix programs will be 6 month studies, with safety extensions out to 1 year. The GNRH antagonist program apparently has 2 good backup compounds that may be used for PCOS, polycystic ovarian syndrome. The GNRH compounds seem to have solved the gentox issue that has plagued other efforts in the field (ie, MRK). Finally, NBIX expects to put an IND forward for 1 of thier other discovery programs. I am interested in the undisclosed target for ET, essential tremor. Huge market here IMHO. Jim