Biotech Values

[DewDiligence]

Re: Macugen phase-3 data:

>> Am I reading that [table in #651] right? Only a 4% gain over placebo whose population seems to be better off not doing anything on the negative side? <<

Yes, you are reading the numbers correctly. However, the primary endpoint of the Macugen trial --an improvement relative to placebo in the proportion of patients experiencing a change of >-3 lines at one year— relates to the third row of the table where Macugen enjoyed a 70% vs 55% advantage relative to placebo.

The 2% figure in the first table row for the placebo group can be explained by the fact that an undisclosed number of patients with predominantly-classic AMD (the disease subtype for which Visudyne is approved in the U.S.) received an undisclosed number of Visudyne treatments during the course of the trial. Patients with predominantly-classic AMD comprised 27% of the total in both the Macugen and placebo arms.

Despite the unimpressive Macugen data overall, after listening to QLTI’s panel of ophthalmologists last week I am a more convinced that Macugen will ultimately be approved by the FDA. The reason is that Macugen appears to show some modest efficacy in the minimally-classic and occult groups where Visudyne’s efficacy has either been nil or has been limited to even narrower subgroups such as occult patients with small lesions.

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If anyone is rushed for time and can’t listen to the entire webcast of last week’s QLTI panel discussion, I especially recommend the portion of the presentation given by Dr. Jordi Monés, Associate Professor with the Institut de Microcirugia Ocular de Barcelona. Prof. Monés speaks quickly, but his slides are crammed with pertinent information.