The HCV patient pool in Japan is about 1/3 of the US patient pool, and the approximate genotype breakdown is 70% GT1b, 25% GT2, 5% other. GILD’s 12-week regimen of Sovaldi + ribavirin was approved in Japan for GT2 patients in Mar 2015 (#msg-112119676) with a list price of $44K. (The Japanese price for Harvoni has not yet been disclosed.)
BMY’s 2-DAA regimen of Daklinza + Sunvepra was approved for GT1 patents in Jul; 2014 (#msg-104052709).
ABBV/ENTA’s 2-DAA qD regimen of ABT-450/ABT-267 (w/o ribavirin) is pending review in Japan for GT1b, with a decision expected in 4Q15 (#msg-110794723). Approval will result in a $30M milestone payment for ENTA. ABBV also plans to submit the same regimen for Japanese approval in GT2 patients before the end of 2015; this submission will be based on data from the GIFT-2 study, which have not yet been reported (https://clinicaltrials.gov/ct2/show/NCT02023112 ). Note: For all patients genotypes in Japan, ENTA’s royalty rate on the 2-DAA regimen will be 50% higher than ENTA’s royalty rate on Viekira Pak in the US and EU.
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