Biotech Values

[DewDiligence]

Japan approves BMY’s 2-DAA regimen for GT1b HCV:

http://finance.yahoo.com/news/japan-approves-first-oral-interferon-110000690.html

The approved regimen is 24 weeks of Sunvepra (f/k/a asunaprevir, a protease inhibitor) + Daklinza (f/k/a daclatasvir, an NS5A inhibitor). The indication is GT1b* patients who are either treatment-experienced or ineligible for interferon treatment; from a practical standpoint, this language is tantamount to approval for either treatment-experienced or treatment-naïve patients.

GILD and ABBV/ENTA each have regimens tailored for the Japanese market, which consists almost entirely of GT1b and GT2, so it won’t be long until BMY has serious competition for the HCV market in Japan. (GILD’s GT2 application in Japan has already been submitted: #msg-103797270.)

*Formally, the approval is for GT1 patients; however, in Japan GT1 almost always means GT1b.