Biotech Values

[DewDiligence]

ABBV/ENTA’s Phase-3 HCV Program in Japan

Unlike the nine global phase-3 trials enumerated in #msg-94927196, the two
phase-3 trials for the Japanese market are testing the 2-DAA regimen of the
protease inhibitor, ABT-450 (licensed by ABBV from ENTA) and the NS5A
inhibitor, ABT-267. For GT1b patients, ribavirin is not included, so this
is a qD regimen. For GT2 patients, ribavirin is included, so it’s a BID regimen.

Please note that ENTA derives a larger royalty rate on sales of the 2-DAA
regimen than on sales of the global 3-DAA regimen because ABT-450 represents
a larger share of the contractual value when there are only two drugs in the cocktail.

There are now two Japanese phase-3 trials on clinicaltrials.gov (h/t @lomu_j):
one for GT1b and one for GT2, the two most common genotypes in Japan.


GIFT-1—treatment-naïve and treatment-experienced GT1b with and w/o cirrhosis;
ABT-450+ABT267 for 12w vs. identical regimen delayed by 12 weeks of placebo use (i.e.
the same design as SAPHIRE-1 and SAPHIRE-2); patients with cirrhosis will be placed
in a separate open-label arm; 312 patients; expected completion Nov 2014:
http://clinicaltrials.gov/ct2/show/NCT02023099

GIFT-2—treatment-naïve and treatment-experienced GT2 with and w/o cirrhosis;
open-label ABT-450+ABT-267+ribavirin for 12w vs. identical regimen for 16w;
150 patients; expected completion Dec 2014:
http://clinicaltrials.gov/ct2/show/NCT02023112


p.s. In my ENTA valuation model (#msg-94993406), I conservatively ascribed
only $100M of value to ABBV/ENTA’s HCV program in Japan.