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Thursday, October 26, 2006 11:00:22 AM
Indication-wise, at a minimum Cortex should be able to carve out the various orphan indications (Frag-X, Huntington's, post-ECT, etc). There's a reasonably good chance that the Sleep Related indications (including orphan Narcolepsy and non-orphans like Excessive Daytime Sleepiness, Shift Work, etc) can also be carved out. There's also the possibility of doing an ADHD-only BP deal, and retaining all the N.Amer Neurodegenerative rights.
So the key rationale for the non-Ampakine in-license idea mainly boils down to not having any compounds ready to go. In a presentation a while back, Dr. Stoll said that the prospect of sitting around for several years waiting to get another compound up to speed is very unattractive from a CEO's perspective. So bringing in another company's late stage orphan program does make some sense. Originally he was talking about a Phase 3 program, now it sounds more like a Phase 2 program.
An alternate approach would be to just sit tight while CX-701 gets through Phase 1, then move it into Phase 2a for Narcolepsy/Sleep Related. Or if Cortex does an ADHD-only deal, retaining the N.Amer Neurodegenerative rights, we could move CX-701 into a Phase 2a in AD or MCI. The time lag waiting for CX-701 is still there however, and waiting for a high impact will take even longer, so that's the dilemma.
The other possible approaches I can think of are - 1) to forgo the BP deal and take CX-717 into Phase 2b in ADHD ourselves, or 2) do an ADHD-only deal with someone like Shire and try to carve out the co-use of CX-717 (very unlikely Shire would go along with that though).
Based on Dr. Stoll's presentation comments, it sounds like they're definitely moving toward the non-Ampakine in-license direction.
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