Replies to post #856 on Biotech Values

[DewDiligence]

Re: Squalamine may have just gained a year relative to Lucentis:

To clarify #856 and eliminate a possible misunderstanding: "two-year follow-up” means actual treatment rather than just observation. I.e., patients in each of the two phase-3 Lucentis trials will receive a needle in the eye each month for up to 24 months (ouch).

[DewDiligence]

Lucentis update from today’s Novartis CC:

The first release of data from the two phase-3 Lucentis trials is not planned until 2006.

As discussed in #856, Lucentis patients will be treated for two years, even though the primary endpoint in the trials is visual acuity at one year.

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P.S. drbio: NVS has begun phase-3 patient enrollment in LAF237.

[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.