Replies to post #186836 on Biotech Values

[kris_kade]

Thanks for positing this very good news. Absence of Riba is a big game changer.

Adding more Enanta tomorrow :-)

[DewDiligence]

Addendum to #msg-110425636: ENTA gets a $30M milestone from ABBV on Japanese approval of the 2-DAA regimen.

[dewophile]

HCV japan
the 3 dropouts (2 from SEs and one just lost to follow up) hurt the numbers here - would have been 97%, but still solid. ironically here GILD's data from the ION studies is going to have to be used against them to show they are roughly the same in GT1b non-cirrhotics, since they had 88/88 SVR in their Japanese study. Both seem more competitive than BMY (low 90s SVR), and to get a sense of the market in japan BMY with a good but not great regimen sold 200M+ last quarter (I think EU sales of daclatasvir were minimal)

not sure why ABBV didn't PR the cirrhotic data - I assume bc not good? if so GILD will have that market to themselves in japan

[DewDiligence]

ABBV submits Japanese NDA for GT1b HCV, based on the outcome of the GIFT-1 study (#msg-110425636):

http://finance.yahoo.com/news/abbvie-submits-drug-application-japan-030400708.html

A separate NDA will be submitted for GT2 patients based on the GIFT-2 study (#msg-110425636) if the data (not yet released) support a submission.

ENTA will receive milestone payment(s) from $ABBV totaling approximately $30M for Japanese approval of the two NDAs. Whether this is in the form of a lump sum or two $15M payments for each of the Japanese NDAs has not been disclosed.

Note: ENTA’s royalty rate on ABBV’s HCV sales in Japan will be 50% higher than in the US and EU because the Japanese regimen consists of two drugs rather than three.