The two latest posts by Harry at Yahoo (thanks, Bob!)........
The Janssen agreement covers US and international markets. Outside the US, royalties on the CRF molecules partnered
with Janssen (NBIX has its own inhouse molecules not yet partnered with anyone) would be in the 8-10% range. In the US,
NBIX will have the option of either low-mid teen% royalties OR having the lower royalty rate plus launching its own sales
force for 25% of the market, paid for by Janssen. NBIX negotiates very nice deals for itself compared to a lot of its
brethren.
Also--the timeframe for commercialization suggested by someone earlier is overly optimistic. The plan by Janssen has been
conservative--further Phase II studies have either started (a dose-ranging trial) or will start early in 2000. A Phase III thus is
unlikely until 2001--with completion and analysis, an NDA might happen mid-late 2002. This would place FDA approval
mid-late 2003, followed by a launch late that year or beginning of 2004.
NeuroInvestment (www.neuroinvestment.com)
While I have recommended NBIX since 9/97, some of the speculation here has verged on the hypomanic. Just to note:
1) The absence of sexual side effects is already offered by such marketed antidepressants as Serzone (has antagonist effect
on 5HT-2c receptor subtype, unlike other SSRIs) and Wellbutrin (not serotonergic). I am not looking to debate the merits of
those drugs, just to note that this is not the unique advantage one hopes will be reported for CRF antagonists. The key will
be rapidity of onset--if Janssen has data that shows that, that will be a big plus (but note that NeuroSearch has an SSRI
variant that also claims earlier onset). If not, then CRF antagonism will be slugging it out in the trenches with a slew of well
entrenched molecules, and talk of a $10 billion market for one drug alone is absurd.
2) I see no reason to expect priority review 'fast-tracking' from the FDA. Even if they acknowledge depression is
life-threatening (which they should), depression hardly qualifies as a disorder lacking effective therapies.
NeuroInvestment (www.neuroinvestment.com) |
