Replies to post #173645 on Biotech Values

[biomaven0]

Do we have a breakdown of the ION trials by GT1a vs. 1b? And of the percentage cirrhosis in the ABBV trials?

Peter

[caravon]

I like ABBV/ENTA results more than GILD results.

[DewDiligence]

GILD’s 2014 sales guidance excludes Sovaldi:

http://finance.yahoo.com/news/gilead-sciences-announces-fourth-quarter-210500473.html

Gilead provided its full year 2014 guidance, which excludes the impact of Sovaldi product sales…

Analysts on the CC starting in 15 minutes will push hard to get some kind of loose Sovaldi guidance, but they may not succeed.

[DewDiligence]

ABBV/ENTA will present detailed results of three more phase-3 trials—SAPHIRE-1, SAPHIRE-2, and TURQUOISE-2—in oral presentations at EASL, April 10-12, 2014:

http://finance.yahoo.com/news/enanta-pharmaceuticals-announces-data-presentations-090500374.html

TURQUOISE-2 should receive a lot of attention insofar as it’s the only large phase-3 trial with results for any HCV regimen in 100% cirrhotic patients.

Also at EASL is an oral presentation of a phase-2 trial called M12-999 that tested ABBV/ENTA’s 3-DAA regimen in liver-transplant recipients.

Note: Detailed results of PEARL-3 were presented at CROI in February (#msg-98175067), so PEARL-3 warrants only a poster presentation at EASL.

[DewDiligence]

GILD reports Sovaldi phase-3 results in GT2 Japanese patients:

http://finance.yahoo.com/news/gilead-announces-results-phase-3-203000280.html

…97 percent (n=148/153) of genotype 2 HCV-infected patients receiving 12 weeks of an all-oral regimen of sofosbuvir plus RBV achieved a sustained virologic response 12 weeks after completing therapy (SVR12). SVR12 rates among treatment-naïve and treatment-experienced patients were 98 percent (n=88/90) and 95 percent (n=60/63), respectively. Of the 153 patients who received treatment, 11 percent (n=17) had documented cirrhosis.

This regimen is a lock for Japanese approval in GT2, which is the second most common genotype in Japan. GILD is also conducting a phase-3 trial of Sovaldi + Ledipasvir ± ribavirin in Japanese GT1 patients, which is expected to report data in 2H14.

[jq1234]

GILD ION-1, 2, 3 data from NEJM:

ION-1: Trt naive - For patients with cirrhosis, SVR12 ranged from 94 to 100% among patients with cirrhosis.

http://www.nejm.org/doi/pdf/10.1056/NEJMoa1402454

ION-2: Trt experienced - For patients with cirrhosis who were as- signed to 12 weeks of treatment, the rates of sustained virologic response were 86% for those who received ledipasvir–sofosbuvir and 82% for those who received ledipasvir–sofosbuvir plus ribavirin.

http://www.nejm.org/doi/pdf/10.1056/NEJMoa1316366

[I pooled ION-1, 2 together for cirrhotic patients, SVR12 is 91% for sofo/ledi, 93% for sofo/ledi plus RBV]

ION-3: Trt naive.

http://www.nejm.org/doi/pdf/10.1056/NEJMoa1402355

[DewDiligence]

New survey: FDA-Approval Dates for GILD & ABBV/ENTA HCV Regimens

The PDUFA date for GILD’s Sovaldi + Ledipasvir regimen is 10/10/14; the PDUFA date for ABBV/ENTA’s 3-DAA regimen is 12/21/14. (Please see #msg-96696670 for the phase-3 data supporting these NDAs.)


Q1: When will FDA approve GILD’s Sovaldi + Ledipasvir regimen?

a) October or later
b) September or earlier


Q2: When will FDA approve ABBV/ENTA’s 3-DAA regimen?

a) December or later
b) October-November
c) September or earlier


To vote, please go to
http://investorshub.advfn.com/boards/board_surveymenu.asp?board_id=1418
and select surveys #158.

[bundyelvis]

90-100 percent is ok with me. I tried the other treatment 12 years ago with a 30 percent cure rate and didn't work. I got all the side effects, heart attack, killed my thyroid, and who knows what else.

[DewDiligence]

ABBV/ENTA—From ACG presentation on TURQUOISE-2 study:

http://acgblog.org/2014/10/14/normalization-of-liver-related-laboratory-parameters-in-hcv-genotype-1-infected-patients-with-cirrhosis-after-treatment-with-abt-450rombitasvir-dasabuvir-and-ribavirin/

In patients with cirrhosis, clearing HCV is only one goal… reversing hepatic impairment is another key, perhaps the key, endpoint…

…The improvement in standard blood tests suggests that the SVR with this Interferon-Free, All Oral regimen [ABT-450 + ABT-267 + ABT-333 ±ribavirin] improves the liver.

H/t ‘stockbettor’. (Emphasis above added by me.)

[faxedreceipts]

The achilles heel with the ABBV treatment is that Norvir has to be used to to achieve high clinical results, much less so with HARVONI. Checkmate HARVONI. The competion to Harvoni is a niche player. That's the kiss of death for ABBV.