Miljenko,
I think that the fact that the parent Zopiclone has already had a few million patient doses in Europe should weigh heavily on the FDA. The FDA has been burned a few times now by safety issues that have only shown up after a drug has been in widespread use. Your point that the FDA has never "seen" Zopiclone before is, however, valid. Further, to the extent they do see the NBIX drug as a "me too" this will help as well.
Sleep trials do go pretty quickly, so perhaps the SEPR lead is only a few months.
Some other stuff:
The NRGN drug appears still to be in Phase I trials by their partner, PFE.
SEPR is developing the other zopiclone isomer as an anxiolytic and (perhaps) anti-epileptic. They say it is non-sedating.
Here are some figures (in millions) on Ambien (Searle) and Sonata (AHP, introduced in 1999) sales:
1999: Ambien $520, Sonata $30
2000E: Ambien $600, Sonata $120
2001E: Ambien $650, Sonata $250
Analysts are predicting sales of some $40MM for the SEPR drug in 2003, assuming launch in early 2003 (management projecting late 2002) and no co-promotion.
Peter |
