Biotech Values

[DewDiligence]

Retaane notes from Alcon’s CC:

http://biz.yahoo.com/cc/0/39260.html

1. Phase-3 Retaane data will be released in a PR sometime after the one-year data becomes available in August 2004. (Although it is common for companies to release clinical data at medical conferences, the timing does not work for the 2004 AAO, and it would be unreasonable for Alcon to sit on the data until ARVO 2005.)

2. The Retaane NDA is expected in 4Q04 requesting FDA approval in all three subgroups of AMD (predominantly classic, minimally classic, and occult). This is somewhat surprising because the phase-3 Retaane trial is testing only predominantly-classic AMD (head-to-head vs Visudyne). Evidently, Alcon believes that the phase-2 Retaane data will support approval in the other two AMD subgroups, but this strikes me as a stretch.

3. Further to the above discussion, Jerry Cagle (Alcon’s head of R&D) said that Retaane’s efficacy in minimally-classic patients with small lesions (<4 disk areas) is roughly as good as its efficacy in predominantly-classic patients with the same lesion size. (Not coincidentally, 4 disk areas is the cutoff that CMS is going to use for reimbursement of Visudyne in minimally-classic/occult patients.)

4. Dr. Cagle also took the opportunity to get in a swipe at EYET, noting that the Macugen NDA has been delayed and EYET has canceled its planned head-to-head trial vs Visudyne.