Replies to post #177693 on Biotech Values

[DewDiligence]

ABBV submits Canada NDA for 3-DAA HCV regimen:

http://finance.yahoo.com/news/abbvie-files-drug-submission-health-114500457.html

On May 1st, 2014, Health Canada approved AbbVie's request for Priority Evaluation for its investigational direct-acting antiviral (DAA) regimen with and without ribavirin for HCV genotype 1.

…According to the Public Health Agency of Canada, an estimated 242,500 Canadians are living with hepatitis C, but approximately 21% of those individuals don't know they are infected and remain undiagnosed.

The Canada NDA is based on the same data package as the US and EU submissions (#msg-96696670). For ENTA, the royalty payable by ABBV on sales of the 3-DAA regimen works the same way it does in the US and EU. Approval of the 3-DAA regimen in Canada, which is likely in early 2015, will entitle ENTA to a small (less than $5M) undisclosed milestone payment from ABBV (#msg-100940717).

Note: ABBV submitted the US NDA for the 3-DAA regimen on 4/22/14 (#msg-100939842) and the European MAA on 5/8/14 (#msg-101692264).