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Enta/Abbvie 2nd gen presentation; there should be more coming as AASLD wraps up
http://www.natap.org/2015/AASLD/AASLD_06.htm
A few comments
This treatment shines in genotype 1; currently the most important/highest prevalence genotype.
It appears that it will be competitive with Gilead's current Harvoni, and the next gen 2DAA (Sovaldi and GS5816)
It also appears that it will offer an 8 week treatment for at least some sub-groups (non-cirrhotic tx naives)
G-2 looks very good.
G-3 looks to be in the 95% range with just 2 pills
(Sof/Vel looks like 95% SVR rate, w/ 30% cirrhotic)
The 2nd gen data isn't as deep as the Gilead but it looks as though it may/should keep Abbvie in 2nd place in HCV.
FWIW, I believe there will soon be more 2nd gen data rolling in, but perhaps, post AASLD; in G-1 both 12 and 8 week, and in G-3 with the optimized dosing- (I presume just 12 weeks)
http://www.gilead.com/news/press-releases/2015/9/gilead-announces-svr12-rates-from-four-phase-3-studies-evaluating-a-oncedaily-fixeddose-combination-of-sofosbuvir-sof-and-velpatasvir-vel-gs5816-for-the-treatment-of-all-six-hepatitis-c-genotypes
I'm not seeing compelling data from JNJ, BMY or MRK.
(no surprise upsets)
Following AASLD data crunchers will have access to the data of HCV infected subgroups and patterns in response (cirrhosis, g-1a vrs 1B, past treatment failures, IL-28 subtypes (C/C, C/T, T/T), etc. (IFN based and past PI exposure)
Until this has been posted it's pretty difficult to compare all the new therapies, but it should soon become more clear.
Why this Merck doublet is expected to beat up on V Pak? Based on data released, it can't handle RAVs and doesn't work well @ high VL "one at 948k, 3 between 1-2M iu/ml, 3 between 2-4M, 3 between 4-6M, 3 w VL 6M " .
MRK's 3-DAA regimen doesn't look that great either:
#msg-118526734
#msg-118527569
RAVs turn Merck doublet into loser?
Jacobson et al, clearly
demonstrate that in patients with baseline resistant variants (RAVs) who are
GT1a there is a significant difference in SVR12. Based on population
sequencing (high copy number of RAVs for detection), patients with protease
RAVs have an SVR12 of 58% vs 98% for those without (72% vs 98% with
lower cutoff of next-gen sequencing) and for the NS5a a similar pattern holds
where SVR12 is 72% for those with baseline RAVs and 98% for those without
(91% vs 98% with next-gen sequencing). Thus, it is clear the Merck doublet is
impacted by baseline resistance which could hamper its uptake.
ABT-493/ABT-530 phase-2b data from AASLD: #msg-118523846.
ENTA MC = 2X cash(2017)
Street expects ABBV 2nd gen to do worse than Harvoni in the most challenging population that is generating most of the scripts.
Harvoni + ribavirin for 12 weeks is now an FDA-approved regimen for GT1 treatment-experienced cirrhotic patients (as an alternative to Harvoni alone for 24 weeks).
First phase-3 trial of ABT-493/ABT-530 now listed: #msg-118483600.
The Sovaldi/Olysio regimen has been rarely used since Harvoni was approved, so any safety issues with that combination are immaterial from an investment standpoint, IMO.
In an article published October 9, 2015 in the journal ACG Case Reports, researchers identified a potential new side effect of colitis with the sofosbuvir/simeprevir combination therapy in patients with chronic hepatitis C (HCV) genotype 1.
http://hepatitis-c.curetoday.com/news/colitis-reported-with-drug-combination-in-hcv-treatment
As you probably know, that's an in vitro analysis by ABUS (f/k/a TKMR), which is a company dedicated to HBV (rather than HCV).
Data from a new cyclophilin inhibitor
The degree of STG-175 antiviral efficacy was HCV > HIV-1 > HBV.
The addition of STG-175 together with virus totally blocked HCV and HIV-1
infection and greatly attenuated HBV infection. When added
3 days post-infection and then every 3 days, STG-175 totally
eradicated the pre-established HCV infection, almost totally
aborted the established HIV-1 infection and prevented the viral
expansion of the pre-established HBV infection.
Not so dead money now, is it?
One follows the herd at the risk of going over a cliff together or with a severe case of buyer's regret.
And in this case,quite severe. 18 to 32 in less than 2 wks time is none too shabby in my book.
I thought ENTA was going to have a long hold down period while all this was sorted out, and I'm delighted to see that I'm indeed wrong with my assumption...
ENTA presenting at Credit Suisse conference 11/10/15, 1pm ET:
http://finance.yahoo.com/news/enanta-pharmaceuticals-present-credit-suisse-130000405.html
Apparenlty not (eom).
Thanks to Dew for shining light on ENTA this week, he is the biotech lighthouse for dummies. Another well followed poster was predicting VPak's demise.
ABBV echoed ESRX wrt the revised V-Pak FDA label:
Answer2 final question on $ABBV CC re-iterated: revised FDA label4 V-Pak not material change wrt sales. (Echoes what $ESRX said on its CC.)
— Roy Friedman (@DewDiligence) October 30, 2015
The tape turned green after ABBV's statement on V-Pak guidance during the CC Q&A (#msg-118117768).
Why no positive rxn in stock price of ENTA?
Can 4 millions shares be shorted without MM who set the price?
ABBV’s latest HCV guidance: #msg-118117768.
It is just math. Looks like he is paying the tax liability of exercise with cash and the fact that he is willing to do that indicates to me that he is extremely happy with the price of the shares that he is getting. Looks like around $400K cash outlay to cover the tax for nearly 70K shares. Good for him and a data point on his view of the stock price for us.
"Viekira Pak totaled $469 million, which fell short of the average Wall Street estimate of $506 million, as compiled by Evercore ISI."
http://www.reuters.com/article/2015/10/30/abbvie-earns-idUSL1N12T49220151030
Why no positive rxn in stock price of ENTA? What am I missing?
Why US docs prefer Harvoni by such a wide margin? Kickback?
US
V-Pak 242 8.7%
EU
V-Pak 227 29.9%
3Q15 V-Pak sales of $469M increased 21% vs 2Q15:
#msg-118113359
#msg-118113513 (table of V-Pak vs Harvoni in US/EU)
Do you have the same or different answers to Randy's question now, in light of what you posted?
If Harvoni will remain GILD’s preferred treatment for GT1 patients, what impact this 12-week regimen of Sovaldi/Velpatasvir will have on V Pak?
GILD submits NDA for Sovaldi/Velpatasvir combination: #msg-118073669.
Yes—please see #msg-117924201. Regards, Dew
Hi Dew,
Given all the information to date, would you consider this a good buying point with little or no more risk then before the FDA warning label was added?
As always, thank you for all the information you share and I hope life is treating you well!
Randy
A few comments:
1. Each HCV regimen has to be considered on its own merits.
2. Not all members of the same HCV drug class have similar efficacy and safety.
3. We do not know that the PI component in V-Pak was the cause of the FDA label revision.
4. ABBV/ENTA's second-generation regimen (ABT-493/ABT-530) consists of a PI and an NS5A; however (unlike V-Pak), the PI in ABBV/ENTA's second-generation regimen is not boosted with ritonavir.
In patients with Cirrhosis, will GILD's triple combo have similar side effects as V pak since both regiments contain PI?
I don't understand what risk you're referring to—please clarify.
To lower the treatment duration to 8 weeks, GILD is adding a new class PI drug to their pan-genotype regiment. Is that a big risk since their 2 DAA regiment Harvoni is considered safe?
ESRX CC: No change expected in V-Pak utilization due to revised FDA label.
Newsworthy items from GILD’s 3Q15 CC:
#msg-118037142
#msg-118037560
GILD's HCV regimens currently in testing are primary for non-GT1 patients; Harvoni will remain the main GILD offering for GT1.
p.s. Not sure why you assume that PI's are riskier than other HCV drug classes.
Witnessed what happened to ABBV, is GILD taking a big risk by adding a PI to their pan-genotype regiment if Harvoni is considered very safe?
Updated FDA label for V-Pak: #msg-118006453.
How did you manage to stay cool and calm when your large biotech position suffered 50% haircut? Would you add 25K if the haircut was 20%?
All were either GT1 or GT4, and all (or almost all) were presumably US patients.
Out of 27 cases mentioned in FDA PR, how many were GT1, US patients?
More musings on V-Pak (and what ESRX will do):
#msg-117976477
#msg-117976876
As far as I know, ENTA's cyclophilin inhibitor is being considered only for HCV.
Do you think ENTA have tried their cyclophilin inhibitors on NASH or Hep B? Do they have the technology/ip for diversification? Their proprietary pipeline looks like frozen for the last few years.
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