Replies to post #169229 on Biotech Values

[dewophile]

care to change your tune as to expected outcomes for PEARL 2/3 non-rib containing arms now? if memory serves (I don't have search access) I questioned your estimates

adding abt-333 should only add to these efficacy numbers even though some 1b patients carry a baseline resistance mutation to the drug

[DewDiligence]

EMA may be considering ABBV/ENTA’s 2-DAA regimen of ABT-450 + ABT-267 (w/o ABT-333 or ribavirin) for GT1b (and GT4*) patients (h/t ‘jq1234’):

https://twitter.com/jq1234t/status/469857759916478464/photo/1
http://t.co/s9feCvTvT6

This is the same 2-DAA regimen where ABBV is conducting phase-3 trials in Japan for GT1b and GT2 (#msg-95444387).

In Europe, ABBV/ENTA’s 2-DAA regimen may be approvable for treatment-naïve GT1b patients without cirrhosis, based on data from the PEARL-1 phase-2 study where the SVR12 rate was 95% (#msg-93662501, #msg-93659700).

Although ABBV/ENTA’s 2-DAA regimen will presumably be priced at a discount to the 3-DAA regimen, the royalty rate for ENTA will be higher on the 2-DAA regimen (because ABT-450 comprises a larger portion of the regimen’s value) and the absolute royalty payable to ENTA per sales dollar ought to be at least as high for the 2-DAA regimen as for the 3-DAA regimen.

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*GT4 is mainly a Middle East strain, but it has a prevalence of 5-15% in France and Spain.

[DewDiligence]

Nearly lost in AASLD flurry—ABBV/ENTA’s GT4 results from the PEARL-1 study:

http://finance.yahoo.com/news/enanta-announces-results-phase-2b-130200689.html

PEARL-I studied AbbVie’s all-oral, interferon-free investigational treatment combining two [i.e. no ABT-333] direct-acting antivirals (ABT-450/r and ombitasvir [ABT-267]) with or without ribavirin (RBV) for 12 weeks in non-cirrhotic adult patients with…GT1b and GT4.

…Results showed that 100 percent of genotype 4 patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon and RBV (n=49/49) achieved sustained virologic response rates at 12 weeks post-treatment (SVR12) after taking AbbVie’s investigational treatment with RBV.

…There were no discontinuations due to adverse events...

ABBV/ENTA reported results from the GT1b portion of PEARL-1 in Nov 2013 (#msg-93662501), but the above data for the GT4 portion of the study are new.

(The PEARL-1 GT4 arm without ribavirin produced an SVR of 91%—vs 100% with ribavirin—so inclusion of ribavirin is advisable for this 2-DAA regimen in GT4 patients.)

GT4 is mainly a Middle East strain, but it has a prevalence of 5-15% in France and Spain (two countries with a high proportion of residents with Middle East origin).