Replies to post #160602 on Biotech Values

[DewDiligence]

Sounds like AGN-150998 [DARPin] simply had insufficient differentiation from Lucentis on efficacy. It’s not a dosing issue per se insofar as AGN tested the two highest-tolerated doses from the phase-1 portion of the study in the phase-2 (randomized, controlled) portion (http://www.clinicaltrials.gov/ct2/show/NCT00775411 ).

This is CEO’s comment from today’s AGN CC:

http://seekingalpha.com/article/1390801-allergan-management-discusses-q1-2013-results-earnings-call-transcript

Regarding DARPin, Allergan has completed the initial analysis for the second stage of the randomized controlled Phase II trial comparing 2 doses of the anti-VEGF DARPin and ranibizumab, i.e. LUCENTIS. The data suggest some product differentiation between the DARPin and LUCENTIS but do not support directly moving to Phase III. Instead, we plan to perform additional Phase II work to more completely access safety and efficacy and to guide the Phase III study design. This will likely delay eventual approval by approximately 1 to 2 years compared to starting a Phase III program by the end of 2013.

[DewDiligence]

Are you also significantly less optimistic about AGN's dual-acting (VEGF/PDGF) DARPin in preclinical development? According to yesterday's CC, the plans and timeline for this drug haven't changed at all, but this assertion might include a modicum of spin.