Biotech Values

[DewDiligence]

ABBV/ENTA receive Japanese approval of 2-DAA HCV regimen, Viekierax, for GT1b patients:

http://finance.yahoo.com/news/abbvies-viekirax-ombitasvir-paritaprevir-ritonavir-060000844.html

Japan has 1.5-2M people with chronic HCV (the second largest HCV market of any country) and 70% of Japanese patients have GT1b. I.e., there is a lot of money to be made from treating HCV in Japan, even though the product pricing is apt to be somewhat lower than in the US (#msg-113636291).

Viekierax is a once-daily, ribavirin-free, 2-DAA regimen consisting of 12 weeks of ABT-450 + ABT-267 (which are co-formulated); this is the same regimen approved for GT4 patients in the EU.* Viekierax showed an SVR12 rate of 95% in the Japanese pivotal trial (#msg-110425636).

In Japan, Viekirax will compete directly with GILD’s Harvoni—both regimens are once-daily without ribavirin and have a duration of 12 weeks; Harvoni was approved in Japan in Jul 2015 (#msg-115173303).

BMY’s 2-DAA Japanese regimen, although approved in 2014, requires 24 weeks rather than 12 weeks and is not truly competitive with Viekierax and Harvoni (#msg-104052709, #msg-117023180).

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As a 2-DAA regimen, the economics of Viekierax are better for ENTA than they are for V-Pak (a 3-DAA regimen); for Viekirax, ENTA’s 10-20% tiered royalty is applied to 45% of the overall regimen’s sales (the portion ascribed to ABT-450, rather than being applied to 30% of the regimen’s sales for V-Pak.

ENTA earns a $30M milestone payment for ABBV for approval of Viekierax in Japan.

*ABBV/ENTA 2-DAA regimen for GT4 patients in the US is called Technivie (#msg-115670836), which is identical to Viekierax in terms of economics for ENTA; the only distinction is that the Technivie label includes the use of ribavirin.