Enanta Pharmaceuticals Inc (ENTA)

[DewDiligence]

Exercising early and has tax advantages in certain cases. This has been discussed at length on the Biotech Values Board—see the thread at #msg-109711695 and follow the chain backwards from there.

[tmoney2555]

Why would he exercise calls that don't expire soon and hold onto the shares? I don't see any logic to that

[DewDiligence]

ENTA’s CEO exercised and held $1.6M of options today: #msg-117951247.

[FBI Agent]

Here is what Etrade says from today

MW Enanta Pharmaceuticals upgraded to overweight from equal weight at Barclays

Oct 23, 2015 12:08:00 (ET)


(END) Dow Jones Newswires

10-23-15 1208ET


Copyright (c) 2015 Dow Jones & Company, Inc.

[magness]

Barclays has PT of $16. Considering ENTA's strong balance sheet and future pipeline they must be assuming 0 Vpak sales. ridiculous

[semi_infinite]

Grabbed a bunch and sold a few puts. Puts are extremely illiquid so have to go small and spoon feed. Will do more if a retest of the lows happens although I doubt it will get into the high teens as yesterday. Those prices made no sense. Even current price is questionable as most of the money coming on to the balance sheet has been milestone payments. My average cost is in the mid 20s now. What a gift.

[DewDiligence]

No, ENTA should not buy back any shares, IMO.

[NY1972]

Do you think ENTA should buy shares with Japanese milestone? How much do they need for P1 trials?

[semi_infinite]

Darn it .... I was traveling and missed the negative EV. I hope it sticks around.

[DewDiligence]

Why I added ENTA today @$20.03: #msg-117924201.

[DewDiligence]

ABBV’s PR on V-Pak label change: #msg-117923678.

[NY1972]

Looks like the 4 million shares shorts knew FDA PR coming. Does this make nuke safe for every hep C patient?

[smittypa]

Thoughts on today's free fall----panic likely overdone.
Looks to me like physician error had more to do with the deaths of those cirrhotic patients, and little to do with VPak. I doubt that VPak sales in Europe, which is half the ABBV guidance, will be effected. In the US, the label warning will, IMO, have no impact on ESRX, or other exclusive insurance providers, since costs still rule. Decompensated cirrhotics account for less than 10% of all Hep C patients, and were contraindicated to begin with. I have a feeling any buys under $25, will look very smart, over the next 3-6 months. Back to lurking.

[linhdtu]

dead dough or not i got 1K at 23. will average down if necessary to a few K stake.

[GrthzGd]

Wow, this is great news for GILD.

[biotech_researcher]

Well, however you look at it, V-Pak sales will be at their peak in Q3 2015 for a considerable period of time.

[biotech_researcher]

With it down over 60%? Surely you jest.....

[DewDiligence]

ENTA—I don't think this label change is a game-changer. Such safety updates are pretty common, and they often blow over fairly quickly.

[biotech_researcher]

This is dead money now, done

[10nisman]

ENTA -18% on FDA safety update requiring V-Pak label change

Dew, any thoughts on impact of this? Will V-Pak sales be greatly impacted and now the wait until Gen2 for real uptick?

TIA,
10nis

[DewDiligence]

ENTA -27% on FDA safety update requiring V-Pak label change:

http://www.fda.gov/Drugs/DrugSafety/ucm468634.htm

[linhdtu]

Oops,something bad happens. I saw a twit about fda warning on liver issue.

[willyw]

Absolutely agree.
Thing is.... it seems like it is wise to see the complete data (like treatment numbers and SVR-12's) before saying that it is clear.

It is also possible that the Abbv/Enta 2 drug program will be considered to be safer than a 3 drug.

We have not yet seen just how good the 2nd gen program is. The G-3 data may yet be surprisingly good in comparison.

So it is possible that the Abbv 2nd gen program could be superior; just a little early to assert it.

[willyw]

The way I read your post is there are two groups; both with virtually the same cure rates.

I think the major players have been telling us for some time that they are going for pan-genotypic. It's almost a moot point which is better.

By the way; it is possible to be infected with more than one genotype, and sometimes genotyping tests are not 100% conclusive.

Perhaps I am wrong, but I am not seeing a lot of difference between real world cure rates and trial cure rates; well, in GILD and Abbvie IFN free treatments; its a few % points
(in trials a lost patient may count as a failure. Some stopped dosings due to AE's still result in cures)

[DewDiligence]

It seems that the Abbvie 2nd-gen program could potentially be equal to Gilead’s.

Let’s bear in min that GILD does not yet have a single pan-genotypic regimen; rather, they have: i) Harvoni for GT1; and ii) Solavldi + GS-5816 for non-GT1. Although Sovaldi + GS-5816 works in GT1, it requires a 12w duration, so there’s little point to using Sovaldi + GS-5816 for GT1 patients in place of Harvoni (which has an 8w duration for some patients).

In short, ABBV/ENTA’s second-generation regimen might not only be as efficacious as GILD’s dual offerings, but also simpler from a commercial standpoint.

[NY1972]

Which one is a better combo for the US market? Can it be decided without real world data?

1. Not pan-genotype regiment
12 week treatment => 95% SVR12 rate in GT1 TE, cirrhotic subgroups
8 week treatment => 100% SVR12 rate in GT1 TN
6 week treatment => 90% SVR12 rate in GT1 TN

2. pan-genotype regiment
12 week treatment => 94% SVR12 rate in GT1 TE, cirrhotic subgroups
8 week treatment => 98% SVR12 rate in GT1 TN
12 week treatment => 92% SVR12 rate in GT3 TE, cirrhotic subgroups

[willyw]

Hey, I'll take a stab at it. : )
As you know though.... I'm a relative novice. I do have interest in HCV drugs and try to stay up with what's happening with them.

Do you believe at this rate,Abbvie can still hit their 3B run rate by Dec2015 ?

Few people on boards have that data. That data is skewed, protected, and incompletely reported. Do I think they will hit 3 bill run rate? I actually think they could come close.(To guess though, I'd guess under, but it will be increasing with 4th Q and 1st Q 2016)

When investors look at the US numbers reporting they won't agree.
but..... I think the I think EU and Japan will help
The market share of GILD has been softening a bit, and Abbvie ENTA TRX have been climbing.

When Abbvie mentioned the 3 billion run rate I'm not sure the Highway bill had been factored in; that gave half a billion for HCV treatments to be used by the VA to treat HCV.

Aside from the notion of run rate..... the 2D program will start making incremental headway for G1 in Japan and for G4 in some parts, I think we should stay in the low tier 3Q, but as things ramp up the royalty tier increase could be seen in 4Q.

I think Merck (doublet) will get approval next year, then they still have to launch. It may be mid year before they get any meaningful numbers. I take this to mean that it could be 3 quarters away from now. They are going to be 3rd and will have to scrap like Abbvie has.
I'm thinking the Enanta share price will continue to rise and fall as it has in the past. (we are pretty low now and due for a rise; probably to new highs)

Here is why it could get better though;
1) the first comer advantage is wearing off a bit that GILD enjoyed
2) Gild seriously curtailed the patience assistance program the end of June; how will that affect it's RX numbers? They were taking all rejected by payers; they have since stopped (hint; their RX # are declining)
3)So far I am not seeing huge competition from other HCV programs; Merck, JNJ, BMY. They will have upcoming data, but I'm not sure it looks that compelling; not at AASLD 2015.
Yes, Merck will offer an advantage, but Abbvie may have some locked in agreements, and may even be able to secure more due to the strength of the 2nd gen program. I don't claim to know; we will see.
4) The results of the 500 million Highway bill appropriation to the VA, when reported are essentially a windfall for this year.

I can't track all the numbers; I think they will remain largely unknown/conditional.

I continue to wonder if the JNJ and MRK nukes will pan out. IF they don't, I do not see long term threat to GILD or ABBV/ENTA. It seems that the Abbvie 2nd gen program could potentially be equal to Gileads. Gilead will still be 1st forthe foreseeable future, but I see them losing share to other players.
IF it were to turn out to be a duopoly between GILD and ABBV, it is hard to see ENTA doing poorly, and we will start seeing some upper tier royalties in the future.

The 2nd gen program press from AASLD should bring an increase in share price; it warrants it.

IF we started seeing some off label treating in 1st gen with Sovaldi it could potentially be a new added source....and unexpected revenue source. I'm just speculating on that; we will see if it turns out to be anything. It surely was for Sovaldi/Olysio.

IF Abbvie has to pay too much in royalties to ENTA for an extended period of time, it may lend credence to buyout speculation.

Then it will be the time to buy more because the data as you see it will make it a duopoly between gild and abbvie.

I'm thinking that could be known next spring; we could be up and down and back up by then.

[willyw]

If *8-week* regimen gets 100% SVR12 in GT1 patients, can it get 50% of US market anyway?

First off, it doesn't get 100% of all G-1's; only treatment naive non-cirrhotics, and so far in relatively small numbers.
(but there are other studies that show promising results in other genotypes and in past treatment failures.

We may see that this treatment work on other harder to treat groups, but they will need to run larger more definitive studies.
The data I see looks very very promising. This may not be as good as it gets.

Will they get half the market based on that? Doubtful.
Gilead has a huge great start, and they will lose some market share to Abbvie/ENTA. There are other players and they will get a slice as well.

IF it were true that the Abbvie 2nd gen was superior to Gilds, then yeah, perhaps. We really haven't seen enough to know the answer about efficacy, cure rate for harder to treat sub-types, or safety.

More will be known after AASLD

[NY1972]

Is it so important for Abbv 2nd gen to be pan-genotype regimen? If *8-week* regimen gets 100% SVR12 in GT1 patients, can it get 50% of US market anyway?

[linhdtu]

willy, how about second order effect ? Do you believe at this rate,Abbvie can still hit their 3B run rate by Dec2015 ?

What if Abbvie does not make that and guides down a bit for next yr, enta will probably take it hard.

Then it will be the time to buy more because the data as you see it will make it a duopoly between gild and abbvie.

there is very much such a thing of being right and too early in the stk mkt.

[willyw]

I bought more ENTA a few weeks ago on the strength of AASLD abstracts, then more yesterday on the strength of the late breaking abstracts.

In a nutshell, it looks to me more like a duopoly between Gilead and Abbvie/Enta. So far, I am not seeing compelling evidence on the Merck (IDIX) or JNJ (ALIOS) nukes.

IF you look at a one year chart you'll see ENTA shares slid prior to AASLD, and picked up about the 1st of november. Shares could be soft for the next week or so, but I expect them to climb pre AASLD.

I don't know if anyone has mentioned the Abbvie ist gen combo with Sovaldi? It looks like it could be a potential off label treatment for RAV resistance/past DAA failures.
Who else has a promising treatment for these with currently approved drugs?

Think about the off label use of Sovaldi and Simeprevir.
This treatment also seemed to be pretty effective in G-3


LB-16 High Rates of SVR in Patients with HCV Genotype 2 or 3 Infection Treated with Ombitasvir/Paritaprevir/r and
Sofosbuvir with or without Ribavirin

Although in small numbers the results were 100%; complete SVR-12 data will be revealed at AASLD

LB-20
Retreatment of HCV Genotype 1 DAA-failures with Ombitasvir/Paritaprevir/r, Dasabuvir, and Sofosbuvir

Once again; very small numbers, but what looked like 100% cure rate, for what seemed to be a decent cross mixture of past DAA failures.

I'm wondering, if this was to get the kind of traction that Sovaldi and Olysio (simeprevir) got, this could become a potential new area of income?

Here's on final comment/query.

IF the 1st gen with Sovaldi is that good, what might the Abbvie 2nd gen with a decent nuke do?

Perhaps if I am misinterpreting this, feel free to correct me.

For me, the Abbvie and Enanta data releases look to be some of the best at AASLD in HCV

[DewDiligence]

Please see #msg-117846000 (eom).

[biotech_researcher]

Not Q3 results
Script-wise, the totals are impressive: More than 183,000 hep C scripts were filled through June 30 of this year. At that rate, hep C drugmakers will end up with 386,000 filled scripts for this year, up from about 288,000 last year, Pro Publica says.

Break those figures down by product, and it's clear that Gilead is far ahead of its chief rival, AbbVie ($ABBV), at least so far. Medicare covered almost 120,000 scripts for Gilead's combo pill Harvoni from January through June, compared with 3,352 for AbbVie's cocktail, Viekira Pak. Gilead's Sovaldi, the single-drug sofosbuvir tablet that's combined with other meds, was prescribed almost 24,000 times during the first half of the year.
http://www.fiercepharma.com/story/medicare-covered-46b-hep-c-scripts-h1-and-gileads-big-winner/2015-10-20?utm_medium=rss&utm_source=feedly&utm_campaign=rss

[DewDiligence]

ABBV/ENTA next-gen *8-week* regimen had 100% SVR4 in GT1 patients (late-breaking AASLD abstract):

#msg-117845374

[DewDiligence]

JNJ's 3-DAA cocktail is specific to GT1, as far as I know.

[NY1972]

J&J started phase 2a clinical trial for 4,6,8 weeks in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. How about genotype 3 and others?

[DewDiligence]

What is the percentage of patients who failed to complete treatment because of side effects?

In the two main Viekira Pak phase-3 trials, the overall dropout rates—not merely the dropout rates due to side effects—were 0.6% and 1%, respectively (#msg-94169219, #msg-94817670).

[DewDiligence]

I replied in #msg-117755893. Regards, Dew

[NY1972]

What is the percentage of patients who failed to complete treatment because of side effects?

[biotech_researcher]

Viekira Pak riskier than Harvoni

http://www.fiercepharma.com/story/advera-abbvies-viekira-pak-riskier-gileads-harvoni-hep-c/2015-10-15

[DewDiligence]

Inasmuch as weekly script data comes out on Fridays, it's hard to ascribe today's move to scripts. But I'll take it, LOL.

[Bickema]

ENTA +6%. You might not be but the market sure is.

[DewDiligence]

I don't know; focusing unduly on weekly changes is not enlightening, IMO.

[semi_infinite]

What would explain the step change?

[DewDiligence]

If so, what would be the reason and the sustainability of the higher scripts.

Such a jump has to happen at some point if ABBV is going to meet its guidance for a >$3B annualized run rate by the end of 2015.

[semi_infinite]

Noticed a post on YH saying that V scripts jumped in last week's IMS data. I haven't found anything to confirm this. Has anyone seen this data? If so, what would be the reason and the sustainability of the higher scripts.

[DewDiligence]

Preliminary SVR4 data for ABT-493/ABT-530 in GT2/GT3: #msg-117407605.

[DewDiligence]

ENTA's AASLD line-up includes oral presentations with SVR4 data on the ABT/493-ABT-530 regimen:

#msg-117401934
#msg-117406333

[DewDiligence]

ABBV/ENTA’s Viekierax receives Japanese approval for GT1b patients:

#msg-117296265

[biotech_researcher]

Tnx.