Replies to post #208663 on Biotech Values

[DewDiligence]

p.s. ABBV still holds the FDA priority review-voucher purchased from UTHR for $350M in 2015 (#msg-116321586). (The voucher wasn't needed for FDA review of G/P because G/P had already been granted BTD.)

[willyw]

The exact PDUFA date is not disclosed, but it should be on or about 8/2/17.

http://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm

"A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review)."
(also...) "FDA informs the applicant of a Priority Review designation within 60 days of the receipt of the original BLA, NDA, or efficacy supplement."

So I guess I was thinking that the 6 months would go back to the December 19, 2016 Abbvie NDA.

Likewise.... since for G-1 they were already getting a speedier evaluation, wouldn't that suggest for G-1 a june approval? Is it possible the other genotypes could be approved on the same timeline now as G-1 for G/P?

Where am I making my mistake?

[DewDiligence]

ABBV/ENTA—G/P NDA in Japan was submitted yesterday, according to ENTA’s Leerink webcast today.

[DewDiligence]

New ENTA slide set:

http://phx.corporate-ir.net/External.File?t=1&item=VHlwZT0yfFBhcmVudElEPTUyNDkxMjV8Q2hpbGRJRD02NjAyNTA=

[DewDiligence]

ABBV/ENTA—CHMP approves 8-week duration of Viekirax/Exviera* for treatment-naïve GT1b patients (except those with severe cirrhosis):

http://finance.yahoo.com/news/enanta-announces-chmp-grants-positive-110000679.html

When rubber stamped by the European Commission in a few months, the CHMP’s label expansion for Viekirax/Exviera should increase ABBV/ENTA’s market share in the EU, which is a predominantly GT1b market where Viekirax/Exviera already has a market share in the mid twenties (#msg-128526031).

However, the sales uplift for ABBV/ENTA from having an 8-week option for Viekirax/Exviera will be relatively short-lived insofar as ABBV/ENTA’s pan-genotypic G/P will be on the market in many EU countries within the next year or so (#msg-127281791), cannibalizing sales of Viekirax/Exviera.

*The EU brand name for Viekira Pak.

[DewDiligence]

ABBV/ENTA’s G/P HCV regimen receives priority review in Japan:

http://ir.enanta.com/phoenix.zhtml?c=147990&p=irol-newsArticle&ID=2253727

G/P already has FDA priority review (#msg-128359345) and EMA accelerated assessment (#msg-128090944).

The FDA PDUFA date is on or about 8/2/17, and G/P will likely be on the market in all three jurisdictions (US, EU, and Japan) by the end of 2017.

ENTA will receive a cumulative $80M in milestone payments from ABBV for G/P approval in these three jurisdictions.

ENTA will receive tiered royalties on worldwide sales of G/P—see #msg-126723412.

Please see #msg-126481635, #msg-126481950, #msg-127727429, and #msg-122031014 for G/P clinical data and phase-3 program.