Replies to post #173536 on Biotech Values

[ronpopeil]

Nice!

[pollyvonwog]

Wow great data... Very nice to see them moving up that launch data as well!!!

[DewDiligence]

Re: ABBV/ENTA’s 3-DAA HCV data

I refer to the clinical-data table in the PR linked in #msg-96615816. Evidently, ribavirin is not needed for GT1b patients, either treatment-naive, or treatment-experienced, but its is needed for GT1a patients. This is a strong outcome for ABBV/ENTA insofar as GILD’s ION-2 data in treatment-experienced patients (#msg-95103023) suggest that ribavirin will be needed for a 12w regimen in GT1a patients and possibly also in GT1b patients. (GILD has not broken down the ION-2 data by genotype subtype.)

Moreover, ABBV/ENTA’s SVR12 rates results from TURQUOISE-2 in cirrhotic patients—especially the 96% rate in the 24w arm—are better than anyone could have expected.

Bottom line: ABBV/ENTA’s overall phase-3 package (SAPHIRE-1, SAPHIRE-2, PEARL-2, PEARL-3, PEARL-4, and TURQUOISE-2) is an extremely compelling package that can easily hold its own again GILD’s ‘ION’ studies (#msg-95103023).

[DewDiligence]

Re: Timing of FDA approval for ABBV/ENTA’s 3-DAA regimen

AbbVie announced it expects U.S. launch [of 3-DAA HCV regimen] in 2014.

ABBV/ENTA’s 3-DAA regimen has an FDA Breakthrough Therapy Designation, which ensures a priority review of <=8 months. With the NDA submission planned for April, an FDA review lasting less than the full 8 months would conclude during 2014. Hence, ABBV’s updated guidance for a product launch in 2014 presumes that the FDA will take somewhat less than the full 8 months to review the NDA, which seems reasonable given the strength of the dataset.

An alternative interpretation of ABBV’s revised guidance for a 2014 product launch is that ABBV hopes to beat its own guidance for an NDA submission in “early 2Q14” by submitting the NDA in March.