Enanta Pharmaceuticals Inc (ENTA)

[willyw]

FDA's Approval Of A Cheaper Drug For Hepatitis C Will Likely Expand Treatment- NPR

http://www.npr.org/sections/health-shots/2017/10/04/555156577/fdas-approval-of-a-cheaper-drug-for-hepatitis-c-will-likely-expand-treatment

[DewDiligence]

Mavyret scripts for week ending 9/22/17: #msg-135002682.

[DewDiligence]

That's not Barron's per se—it's a sell-side note from Maxim Group that Barron's picked up for one of its online trading blogs. We'll soon know if it's accurate.

[willyw]

http://www.barrons.com/articles/gileads-china-entrance-looks-crowded-1506532587

Seems to corroborate;

"As a reminder, Daklinza and Sunvepra, Bristol-Myers Squibb’s (BMY) dual-drug regimen was previously approved by the CFDA in April. It was the first direct-acting antiviral agents approved in China. In addition, Olysio (commercialized by Johnson & Johnson (JNJ)) was approved this past August, and AbbVie’s (ABBV) ombitasvir/dasabuvir, was approved on the same day as Sovaldi. We also note that the CFDA accepted Ascletis’ (a domestic Chinese specialty pharma company) Danoprevir application for approval in January and Merck’s (MRK) Zepatier application for approval in August."
============

I don't know how to prove this, short of calling ABBV or ENTA public relations. One would think Barrons is correct.

If it were so, by some mechanism I don't understand, the 3-D 1st gen program would have been approved in China before Harvoni.
In the USA Harvoni was approved 10-10-2014 and Viekira was december 2014; about 2 months later.

In the USA, Harvoni approval followed Sovaldi approval by about 10 months.

Main point is, if Abbvie was successful with the 1st gen program approval in China, could it also be true they may be adept with the 2nd gen Maviret?

Dew, I don't want to post bad info, but if this is....IF it were to be correct you'd want to know.
I agree that you would think there would be a release from ABBV or ENTA.

Here is the next thing...

If it is so that Viekira is now approved in China, ENTA should start seeing some increased revenue from the 1st gen when people are expecting it to decrease.

Feel free to delete if you feel this is in error

[DewDiligence]

Many investors think that HCV is tapped out. I notice that the number of infected in the USA could still be higher than when sovaldi was first approved; partially due to uncertainty of estimates and partially due to the current opioid crisis.

Excellent point. Please post that on the Biotech Values board.

[DewDiligence]

The SA piece is assuredly wrong about Viekira approval in China. ABBV and ENTA would have issued press releases for that.

[willyw]

Maviret in China?

So enta has had a great several months. This week the news is also looking good; approval in Japan and what seems to be encouraging updates (and data release at AASLD) on ENTA's FXR agonist, EDP-305.

Gilead also had good news with approval of Sovaldi in China which is a large market. (10 million HCV infected)
What are the prospects and timetable for Maviret?
BMY got in early; might Abbvie?

I can't speak to the accuracy of this, but if true, abbvie G/P approval could be earlier than market expects.

https://seekingalpha.com/article/4110203-gilead-spruces-large-target-market
"One of Gilead's bigger competitors in the Hepatitis C space, Abbvie (ABBV) saw approval for its drugs ombitasvir and dasabuvir the same time that Sovaldi was approved in China. "
(I almost doubt this; I wonder if the author meant Harvoni, not sovaldi- regardless the approvals may not roll out exactly in the same sequence and timetable as they were US and OUS)

No doubt both Gilead and Abbvie are are attempting to bring their HCV programs to approval ASAP.
It will be interesting to see how rapidly the current GILD and ABBV HCV programs are approved in China.

Many investors think that HCV is tapped out. I notice that the number of infected in the USA could still be higher than when sovaldi was first approved; partially due to uncertainty of estimates and partially due to the current opioid crisis.

IMHO there is a lot of market left, particularly for a pangenotypic 8 week program.
I have to wonder if both GILD and Abbvie programs will see very rapid approvals.
Any way to estimate approvals times?

[DewDiligence]

ENTA’s AASLD presentations for EDP-305 (NASH/PBC):

https://www.businesswire.com/news/home/20170927006300/en

[DewDiligence]

Japan approves Maviret, triggering $15M milestone payment: #msg-134935488.

[DewDiligence]

Mavyret scripts for week ending 9/18/17: #msg-134887306.

[DewDiligence]

New slide set from CF presentation today:

http://ir.enanta.com/static-files/6260935a-3ef6-4854-ac8e-03595d82bfa9

[DewDiligence]

Highest intraday and closing prices since Aug2015 (eom).

[DewDiligence]

Mavyret scripts for week ending 9/8/17 (from IMS)…

TRx: 185, +29% from prior week
NRx: 156, +14% from prior week

Note: Mavyret’s absolute script figures reported by IMS are low because IMS misses much of the public sector of the HCV market that ABBV is targeting.

[DewDiligence]

Yes, I erroneously switched the numbers—will repost. Thanks for noticing!

[DaveAu]

Shouldn't Total be bigger than new?

[Bickema]

RBC Capital initiates coverage on Enanta Pharmaceuticals (NASDAQ: ENTA) with a Outperform rating and a price target of $54.00.

[Bickema]

Thank you Dew.

[DewDiligence]

Mavyret scripts for the week ending 9/1/17 were up modestly from the prior week, but the numbers aren't especially meaningful since it was a holiday week.

Scripts for the week ending 9/8/17 will be reported tomorrow.

[Bickema]

Dew or Anyone else seen any new script numbers? TIA

[DewDiligence]

ENTA adds director—BoD size increased to 7:

http://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-appointment-kristine-peterson

[willyw]

Very positive day...
...and week, and month and year so far.

The trend is (y)our friend. : )

[DewDiligence]

Possibly, but Zacks isn't taken seriously by seasoned biotech investors.

[JK2016]

Or maybe this helped:

http://www.nasdaq.com/article/surging-earnings-estimates-signal-good-news-for-enanta-pharmaceuticals-enta-cm835874

[DewDiligence]

...weekly prescription counts may be where we see first action.

I presume that's what is driving today's move.

[willyw]

G/P Phase 3b trials; Sofosbuvir failures (in Genotype 1).

https://www.centerwatch.com/clinical-trials/listings/external-studydetails.aspx?StudyID=NCT03092375&CatID=79

https://clinicaltrials.gov/ct2/show/results/NCT03092375

I read a report that at the clinical trial site they were reporting a 97% cure rate- probably from prior trials. We will see what this trial brings in.

By the way, in visiting various HCV forums, I have not yet encountered anyone who has started w/ G/P. Forum traffic is down considerably, so weekly prescription counts may be where we see first action.

[DewDiligence]

Maviret* approved in Canada:

https://finance.yahoo.com/news/abbvies-maviret-approved-health-canada-130300201.html

ENTA does not receive a milestone payment from ABBV for Maviret approval in Canada, but they do get a $15M milestone payment from ABBV for approval in Japan, which is expected in the next two quarters.

*Note spelling, which is the same as the brand name in the EU but differs from the “Mavyret” brand name in the US.

[DewDiligence]

Pro forma cash, diluted share count, and enterprise value:

#msg-133716016
#msg-133716256
#msg-133716361

[DewDiligence]

ENTA FY3Q17 CC transcript:

https://finance.yahoo.com/news/edited-transcript-enta-earnings-conference-225208610.html

[DewDiligence]

ENTA reports FY3Q17 results:

http://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-13

CC at 4:30pm ET.

[DewDiligence]

FDA approves ABBV/ENTA’s Mavyret: #msg-133548596.

[DewDiligence]

European Commission approves GILD’s Vosevi and ABBV/ENTA’s Maviret, direct competitors in HCV:

#msg-133376275 Vosevi
#msg-133380725 Maviret

[DewDiligence]

FY3Q17 CC 8/7/17, 4:30pm ET:

https://finance.yahoo.com/news/enanta-pharmaceuticals-host-conference-call-200000411.html

[DewDiligence]

Vosevi’s US list price leaves ample room for competition from G/P: #msg-133123185.

[DewDiligence]

I don't have any company-specific explanation. Note that XBI is down >1% today.

[guyschmid]

Anyone care to speculate why the stock is down so sharply over last couple of trading days?

[biotech_researcher]

News for 'ENTA' - (*DJ Enanta Announces New Data on EDP-938, a Novel Non-Fusion Inhibitor of Respiratory Syncytial Virus (RSV), at the XIX Intl Symposium on Respiratory Viral Infections)


(MORE TO FOLLOW) Dow Jones Newswires (212-416-2800)
June 26, 2017 07:31 ET (11:31 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.- - 07 31 AM EDT 06-26-17
Source: DJ Broad Tape

[DewDiligence]

ENTA will receive an undisclosed milestone payment from ABBV when Maviret is rubber-stamped by the EU Commission in about 2 months; my estimate is $30M.

[DaveAu]

Sweet. I'll bet Dew didn't have the nifty new name built into his model or that this includes Liechtenstein.

[DaveAu]

Enanta Announces that AbbVie Receives CHMP Positive Opinion for MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

https://finance.yahoo.com/news/enanta-announces-abbvie-receives-chmp-114400217.html

Enanta Pharmaceuticals, Inc. (ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted AbbVie a positive opinion recommending marketing authorization of MAVIRET™ (glecaprevir/pibrentasvir), an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus (HCV) infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week treatment option for HCV patients across all genotypes (GT1-6) without cirrhosis and new to treatment, who comprise the majority of people living with HCV.1 The European Commission will now review the CHMP opinion and a final decision is expected in the next quarter. Glecaprevir is Enanta’s second protease inhibitor being developed through its collaboration with AbbVie and is one of the two new direct-acting antivirals (DAAs) combined in MAVIRET.
The CHMP positive opinion is supported by 97.5 percent (n=807/828) SVR12 rates with 8 weeks of MAVIRET across GT1-6 chronic HCV-infected patients without cirrhosis and new to treatment, with varied patient and viral characteristics.2 In an integrated analysis (n=2,265), less than 0.4 percent of patients discontinued treatment.3 The reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue.3 The type and severity of adverse reactions in patients with cirrhosis were comparable overall to those seen in patients without cirrhosis.3
“HCV is a global health problem and MAVIRET has the potential to address the majority of patients with a simple 8-week treatment option,” stated Jay R. Luly, Ph.D., President and CEO, Enanta. “We are pleased to have our second protease inhibitor be part of this exciting new HCV regimen.”
MAVIRET is also intended to be an additional option for patients with specific treatment challenges. These include chronic HCV patients with compensated cirrhosis (Child-Pugh A), and those who currently have limited treatment options, such as patients with severe chronic kidney disease, including those on dialysis, and patients infected with genotype 3.
The marketing authorization application (MAA) for MAVIRET is under an accelerated assessment, which is granted by the EMA to new medicines of major public health interest. The MAA evaluation is conducted under the European Union’s centralized licensing procedure, and if approved will result in a marketing authorization valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. It would then be subject to separate reimbursement approvals in each of the member states. AbbVie’s investigational, pan-genotypic combination of glecaprevir/pibrentasvir has also been granted priority review designations by the U.S. Food and Drug Administration and Japanese Ministry of Health, Labour and Welfare. MAVIRET is an investigational regimen and its safety and efficacy have not been established by any regulatory approval.
About MAVIRET™ (glecaprevir/pibrentasvir)
AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) clinical development program was designed to investigate a pan-genotypic, once-daily, ribavirin-free treatment with the potential to provide a faster path to virologic cure** for all major HCV genotypes (GT1-6) and with the goal of addressing specific treatment challenges, including compensated cirrhosis (Child-Pugh A), chronic kidney disease and genotype 3. MAVIRET is being evaluated as a potential 8-week, pan-genotypic treatment for the majority of people living with HCV,1 namely those without cirrhosis and new to treatment,* and regardless of viral and patient characteristics.
MAVIRET is a fixed-dose combination of two distinct antiviral agents: glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets.
*Patients who are treatment-naive or had prior treatment experience with IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN).
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

[DewDiligence]

ENTA’s pro forma EV is only $412M: #msg-131344710.

[stockbettor]

Early access to G/P in UK

UK patients get early access to AbbVie’s hepatitis regimen
11th May 2017

The positive scientific opinion by the Medicines and Healthcare Products Regulatory Agency enables the regimen to be accessed by adults with compensated cirrhosis and at least one of the following: GT 1, 4, 5 or 6 infection and prior treatment with an NS5A inhibitor; GT 2, 3, 5 or 6 infection and chronic kidney disease stage 4 or 5; or GT 3 infection previously treated with peg-interferon, ribavirin and/or sofosbuvir

http://www.pharmatimes.com/news/uk_patients_get_early_access_to_abbvies_hepatitis_regimen_1192670?utm_medium=nl&utm_source=internal&mrkid=649348&mkt_tok=eyJpIjoiWVdZd1pXSXhZbU01TldFNCIsInQiOiJyVUxWNzNQNUVEckd0OWt0bUxTRWVaVjl0UDkzdzVJd1VDQUtWUG5Da2tWUTh4QnphWmhENitDTlJaMnVrdTZuaVdaRXVmdU1sU3JveTRTVnJqWlc0SU5Cam9GaUJlXC9JeDlWcCs2RU9hWTljYUtcL1VaeXVGa0pYdXRFOTZRcTN4In0%3D

[DewDiligence]

ENTA reports FY2Q17 financial results:

https://finance.yahoo.com/news/enanta-pharmaceuticals-reports-financial-results-200100447.html

Cash at 3/31/17 was $240.9M, a decrease of $3.5M from the 12/31/16 amount (#msg-128545809).

CC at 4:30pm ET.

[DewDiligence]

ENTA mentioned in Reuters profile of NASH arena: #msg-130744801.

[DewDiligence]

JNJ/ACHN’s 3-DAA HCV regimen has a problem: #msg-130712374.

[DewDiligence]

Brief comments on today's PR: #msg-130606473.

[biotech_researcher]

Enanta Announces New Preclinical Data on its FXR Agonist EDP-305 for Non-Alcoholic Steatohepatitis (NASH) & Primary Biliary C...

http://ih.advfn.com/p.php?pid=nmona&article=74367636

[biotech_researcher]

It's low volume at least, but the data sure didn't bring in buying interest..

[DewDiligence]

New info showing EDP-305 superiority to Ocaliva in preclinical models (from yesterday’s Wainwright webcast):

#msg-130198502

[DewDiligence]

I posted the relevant text from today's PR in #msg-130196095.

[biotech_researcher]

Enanta Pharmaceuticals Announces Data Presentations at The International Liver Congress™ 2017
http://finance.yahoo.com/news/enanta-pharmaceuticals-announces-data-presentations-111100737.html