Biotech Values

[DewDiligence]

Lucentis update from yesterday’s DNA CC:

The enrollment timetable for the phase-3 trial in predominantly-classic AMD has slipped again. This trial is now slated to complete enrollment in either 2Q04 or 3Q04. (The most recent guidance had been 2Q04.)

The other phase-3 Lucentis trial –in minimally-classic/occult AMD— completed enrollment at the end of 2003 as previously disclosed.

It’s reasonable to assume that DNA and NVS will opt for a single NDA for Lucentis in all three subgroups of wet AMD. (This is also what EYET plans to do for Macugen.) Thus, the slow enrollment of the predominantly-classic trial is on the critical path and is delaying the NDA and eventual product launch.