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Re: DewDiligence post# 186836

Thursday, 02/12/2015 5:39:41 AM

Thursday, February 12, 2015 5:39:41 AM

Post# of 257262
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.

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