Biotech Values

[DewDiligence]

Miscellaneous HCV notes from ABBV's 1Q14 CC:

• The Japanese NDA for the 2-DAA regimen (ABT-450 + ABT-267 without ribavirin) in GT1b patients is expected to be submitted in 1H15 and could be on the market in late 2015. (Japan is the world’s second-largest country in terms of the addressable HCV market.)

• ABBV/ENTA’s next-generation (pan-genotypic, qD) 2-DAA regimen of ABT-493 + ABT-530 is expected to be launched in the US and EU in 2017 if there is no glitch in the clinical trials. (ABBV declined to offer any intermediate timeline info on this program.)

• The qD formulation of ABBV’s 3-DAA regimen, if it works out, could be launched in the US and EU in 2016. I’m somewhat skeptical of this program because: i) it may not be possible to develop an effective qD formulation that includes the BID drug, ABT-333; ii) a qD formulation of the 3-DAA regimen wouldn’t offer any advantage relative to the existing 3-DAA product other than convenience; and iii) the earliest possible launch (according to ABBV) in 2016 is only one year behind the potential launch of the pan-genotypic qD regimen, so there wouldn’t be a long enough “time in the sun” to make this product worth spending a lot of money to develop.

• CEO Rick Gonzales thinks the HCV market during the next several years will be supply-constrained rather than demand-constrained (which is consistent with my own view).

Please see #msg-101122844 regarding the matter of price competition (where nothing said on today’s CC was new).