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Global phase-3 program for ABT-493/ABT-530: #msg-119515332.
ENTA presenting at JPM 1/13/15, 2pm ET:
http://finance.yahoo.com/news/enanta-pharmaceuticals-present-34th-annual-130000619.html
ABBV presents at JPM a couple of hours earlier, which is helpful for ENTA by allowing Jay Luly to comment on any disclosures ABBV may make regarding the HCV programs.
ABBV 2nd gen will be as good as SOF/VEL, based on this move and what Luly said in last CC:
'There was no virologic failure in the naïve subjects and there was only one virologic failure in the experienced patients that were in either genotypes 1, 2 or 3'
GILD POLARIS-1,2 and P3(genotype 3)
A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection(POLARIS-1)
Estimated Enrollment: 380
Study Start Date: November 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
======================================================================
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection(POLARIS-2)
Estimated Enrollment: 780
Study Start Date: November 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
========================================================================
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis
Estimated Enrollment: 200
Study Start Date: December 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Gild triple combo P3
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
SOF/VEL/GS-9857 (400/100/100 mg) FDC tablet administered orally once daily with food
SOF/VEL (400/100 mg) FDC tablet administered orally once daily without regard to food
Estimated Enrollment: 380
Study Start Date: December 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
EXPEDITION-1 started
A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)
ABT-493/ABT-530 for 12 weeks
Estimated Enrollment: 175
Study Start Date: December 2015
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Very expensive data to go with the $350 million voucher. Patients must be lining up for this trial, free $1000 pill + DCV/day for 12 weeks.
Did FDA request this?
Will MRK P3 triple combo go head-to-head against Sofosbuvir (SOF) and Velpatasvir (VEL) in GT3 patients?
Going head-to-head against Solvaldi + Daklinza in GT3 patients is a gutsy move.
ENDURANCE 2,3 started
A Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 2 Infection (ENDURANCE-2)
ABT-493/ABT-530 for 12 weeks
Placebo for ABT-493/ABT-530 for 12 weeks followed by ABT-493/ABT-530 for 12 weeks
Subject must be HCV treatment-naïve or have failed previous HCV treatment.
Subject must be non-cirrhotic.
Estimated Enrollment: 321
Study Start Date: November 2015
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered With Declatasvir in Adults With Chronic Hepatitis C Virus Genotype 3 Infection
ABT-493/ABT-530 QD for 12 weeks
SOF 400 mg QD + DCV 60 mg QD for 12 weeks
Subject must be treatment-naïve
Subjects must be non-cirrhotic
Estimated Enrollment: 345
Study Start Date: November 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
MRK will complete P2 when ABBV wraps up P3. It made a lot of protocol changes on 10/26:
GT2 C Grazoprevir+MK-3682+MK-8408 (6 weeks) => GT2 C Grazoprevir+MK-3682+MK-8408 (12 weeks)
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 With Either MK-8742 or MK-8408 in Subjects With Chronic HCV GT1 and GT2 Infection
Estimated Enrollment: 465
Study Start Date: January 2015
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
ENDURANCE-4 started recruiting
The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)
Estimated Enrollment: 130
Study Start Date: November 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
According to the trials' start dates, AL-704 is AL-335's backup??
First in Human Study of AL-335; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
Estimated Enrollment: 70
Study Start Date: December 2014
Estimated Study Completion Date: June 2015
First in Human Study of AL-704; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C
Estimated Enrollment: 96
Study Start Date: July 2015
Estimated Primary Completion Date: November 2015
Re: JNJ’s HCV program
Please see #msg-119319641. (My prior post on this subject was mistaken and has been deleted.)
The implication from Medivir’s PR is that JNJ’s HCV program, if not dead, is on life support. JNJ still has the HCV compounds acquired from ACHN, but without the Alios nuke [AL-704] it’s hard to see a viable business plan here.
Are AL-335 and AL-516 backups?
Large block after MRK news.
16:23 $ 31.73 300,100
MRK—EMA nixes “accelerated assessment” of 2-DAA* HCV regimen and will review the application on a standard timetable
Will FDA follow suit?
MRK’s HCV regimen delayed slightly in EU: #msg-119266731.
ENTA names Chairman of BoD:
http://finance.yahoo.com/news/enanta-pharmaceuticals-announces-election-bruce-130000008.html
The 10-K for the fiscal year ending 9/30/15 has been filed:
http://www.sec.gov/Archives/edgar/data/1177648/000119312515401602/d21127d10k.htm
Short Interest = 4,236,497
Shorts are really confident ABBV will have the LEAST sustainable HCV franchise.
FDA accepts NDA for qD formulation of V-Pak: #msg-118870098.
ABBV keep prices reasonable.
http://www.bloomberg.com/news/articles/2015-12-01/gilead-used-revenue-driven-pricing-on-hep-c-drug-senators-say?cmpid=yhoo.headline
That tough negotiating applied to the U.S.’s taxpayer-funded health programs, as well as private insurers. The company offered supplemental rebates of 10 percent to Medicaid, the state-run, U.S.-funded health insurance program for the poor, the senators said. Those rebates, however, came with the condition that states had to drop some or all of their access restrictions, according to the Senate investigation. Only five state Medicaid programs reached agreements to receive extra rebates in 2014, the Senate investigation found.
Prices only dropped for Gilead’s hepatitis drugs after a competing treatment from AbbVie Inc. entered the market in December 2014. That led to the nation’s largest drug benefit manager, Express Scripts Holding Co., making AbbVie’s drug Viekira Pak the preferred treatment for the most common sub-type of the virus, according to the statement.
CFO risk management - he seems to be content to keep his long exposure under 90K shares. So far this year, he sold about 70K shares offset by 30K options. He started the year with around 125K shares.
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001185034
CEO started the year with around 520K shares and currently at 545K shares plus 110K options.
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001571211
ENTA needs safety data on EDP-494 before we talk about adding it to regimens willyw-nilly (heheh).
Were it to be that the new ENTA cyclophillin inhibitor could be added to Abbies 2nd gen program, the Gilead triple might no longer be the best.
If EDP-494 is as good as Luly claimed, J&J and Merck would also want to try it with their HEP C regiment too. They need to try a hail Mary pass to stay in the game.
For treating patients with RAVs from prior DAA failure, the duration of the regimen used for re-treatment is much less consequential than its success rate. I.e., the one thing you absolutely want to avoid is a second treatment failure, possibly leaving the uncured patient with RAVs to overcome.
Even for treatment-naive patients, almost everyone who follows this field of medicine thinks that 4-week regimens are too short. 6-week regimens might be possible for the easiest-to-treat patients, but cutting out only 2 weeks (relative to an 8-week regimen) may not be worth the increased risk of relapse.
Can ENTA come up with a 4, 6 week regiment? Every Goliath has failed so far. According to GILD followers, whatever ENTA creates will be "Too little, too late".
"In this program, we've seen uniform activity of EDP-494 against all HCV genotypes tested so far namely genotypes 1 through 5 and perhaps more importantly uniform activity against all genotype1 RAVs tested today including RAVs from all the major DAA classes. These classes include NS3 protease, NS5A, NS5B polymerase inhibitors both nuc and non-nuc."
Transcript* of ENTA’s FY4Q15 CC:
http://finance.yahoo.com/news/edited-transcript-enta-earnings-conference-065602553.html
*Includes some errors.
NVS obtained its cyclophilin inhibitor from Debiopharm, who reclaimed the rights to the compound when NVS pulled out.
Why the downward reaction this morning in ENTA?
Didn't think anything of note was in the conference call yesterday.
ENTA CC a few thoughts.
It's a pretty rough translation at times, but read and enjoy; (this was from the page 5 Q and A)
http://seekingalpha.com/article/3708036-enanta-pharmaceuticals-enta-ceo-jay-luly-on-q4-2015-results-earnings-call-transcript?page=5&p=qanda&l=last
Q and A
colin from Robert W. Baird & Co.
Luly's answer was that the G-1 8 week had essentially 100% cure rate, except for the cancer patient that died and didn't complete.
You will also notice that the 8 week SVR rates were very close to the 12 week trials.
I interpret that when greater numbers roll in that the 8 week trials for Geno 1's will look quite good
One of the disadvantages of Viekira has been twice a day, and that should switch to once a day dosing. (in 2016 if FDA approved?)
Europe and Japan are solid G1b populations where riba is not needed for Viekira.
In G1b cirrhotics, I think they are seeing that even riba added doesn't add much to the cure rates.
Point is.... Merck may not be such a shoo in for 2nd place, particularity on how the program gets labeled w/ regard to RAVs.
FWIW, Gild took 7977 through phase 3 trials in just 2 years to approval, but with several 24 week trial cohorts.
I would guess that since the trial cohorts will be 12 weeks, but who knows; there may be some conservative ones for treating cirrhotics, or contrasting 12 to 24 weeks (or 18?)
I expect approval in late 2017
I'm expecting better cure rates for the 3rd phase 2nd gen program than we are currently seeing, due to the higher (300 mg ABT-493) dose formula, and based upon the smaller data reported and a few flukes that skewed the SVR rates. I continue to believe that there were some later 2nd gen data that is wrapping up but has not/ was not reported at AASLD.
Nothing to do with the CC, but the Viekira prescriptions have been slowly raising, and the Harvoni, slowly decreasing.
I'm still kinda wondering, what this drug combo would do if combined with Sovaldi? Would it be better than the GILD triple DAA? (efficacy, duration, or curing certain genotypes/subgroups?)
Is NVS the only pharma that put a cyclophilin inhibitor thru clinical trials? Merck, J&J and Gilead seem to be fixated on NS5B inhibitor?
That SeekingAlpha write-up is moronic (eom).
It is obvious I am no PhD, not a researcher either. Trying to learn something from Dew and WillyW everyday.
Thanks for reminding me.
Latest free warning from SA for the funds that own 80% ENTA shares:
"If you are holding ENTA or thinking about buying, you should be warned that it is a very risky play and should protect yourself properly"
http://seekingalpha.com/article/3702916-a-fundamental-perspective-on-enanta-pharmaceuticals
Did anyone buy EXEL for a buck and change when another SA writer predicted it's demise?
I think Luly should be ready to buy shares when FDA changes V Pak's label again, instead of watching the shorts decimate the SP to all time low.
He bought almost 70K shares through early exercise of options on 10/23.
http://www.sec.gov/Archives/edgar/data/1177648/000090866215000319/xslF345X03/edgar.xml
If he is confident in 2nd gen combo, Luly should buy back 10K shares @ $30 everyday with that $30 million. How about buying 8 million CNAT shares to finance their P2 trials?
ENTA receives $30M milestone from ABBV for HCV launch in Japan:
http://www.sec.gov/Archives/edgar/data/1177648/000119312515382975/d214977d8k.htm
Thanks. Nothing new there—the analysts cited by Barron's have been talking up GILD's HCV prospects in every write-up.
IMS forecasts $45-55B worldwide HCV-drug sales in 2020: #msg-118601117.
ENTA/ABBV/GILD - QUARTZ-I: Retreatment of HCV Genotype 1 DAA-failures With
Ombitasvir/Paritaprevir/r, Dasabuvir, and Sofosbuvir
http://www.natap.org/2015/AASLD/AASLD_20.htm
93% SVR12 rate in past DAA exposures
Very small study; 22 patients
100% SVR4 in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or -Experienced Patients With the Combination of ABT-493 and ABT-530 for 8 Weeks
http://www.natap.org/2015/AASLD/AASLD_21.htm
Per the link;
Geno 1 is a 46% prevalence world wide
This was in the higher optimized dosing;
300mg ABT-493 & 120 MG ABT-530
This is just a small trial, but others will be rolling in to confirm results.
Also please note, there is not a lot of difference between 12 and 8 weeks of treatment; close to statistically insignificant.
IMHO, the differences will show themselves in various treatment subtypes
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