Enanta Pharmaceuticals Inc (ENTA)

[willyw]

Positive catalysts for ENTA, possible negatives.

http://finance.yahoo.com/news/enanta-pharmaceuticals-announces-chmp-positive-145200533.html

Today's is chmp positive opinion for treating g-1b without RBV
The FDA is doing the same. Some time this year ENTA (abbv) will likely be treating more cirrhotics. It will also serve to dispel the notion that the drug combo wasn't safe. The labeling change is for compensating cirrhotics; not de-compensating, and pertains to Genotype 1b; not 1a.

At some point this year Viekira will be approved for once daily in the US, possibly this year in the EU as well.

There are a large number of genotype 1b's in the world.
http://www.natap.org/2016/HCV/021916_01.htm
These are markets just starting to open up.

Data on Japan should bring in additional royalties, higher royalty rates, and higher royalty tiers.

http://www.natap.org/2016/APASL/APASL_13.htm

The labeling for Viekira will presumably only improve in the US and Ex US markets; somewhat broader labeling, and easier once a day dosing.

It is likely that the Merck regimen will impact on sales in the US, and later in EU. The Merck program will erode some Abbvie market share and will influence pricing of programs. Gild doesn't expect huge cuts, it may nick Abbvie's more.



2nd gen program

Here is a bit more data at a recent conference

http://www.natap.org/2016/APASL/APASL_02.htm
per table 2 they are claiming for the higher dose;
100% SVR12 in GT1
100% SVR12 in GT2
97% SVR12 in GT3 (I'm going to have to look at this further; surprised me).
We must also keep in mind that this is shallow data. There should be a larger sampling with the higher dosing regimen in upcoming months. This could be unexpected by the markets, but keep in mind it could cut both ways. We will see what the studies show, but this *looks* encouraging.

ABBV has deeper data on this than they have shown.
They should be able to release decent data by mid year and could have preliminary data at EASL. By the way; the data on GT-4's is good too, per my recollection.

They are also conducting 8 week trials in GT1, and I expect high SVR rates there as well.

AS they year time rolls on these therapies will pay more and more attention to RAVs. The 2nd gen program may look even better when seen how it stacks up in that area.

What the Abbvie 2nd gen program really needs is another compound to add to it. It could be a nuke. It *could* be a cyclophillin inhibitor.

Frankly, if the ENTA compound is as good is it appears, it could be used as a stand alone add on to any program; Abbvie's, Gilds, Merck's. IF Enta can find a nuke to partner with 494 it could also become a larger player in HCV. I am uncertain as to the time table ...if if and whens on entering into clinic for a proof of concept for the cyclophillin asset, but it seems quite effective on RAVs. It will be interesting to see the data on it.

Possible up or downsides;
What will the year bring from the JNJ nuke program? The Merck nuke program? RGLS?

Time will tell, but progress is an uphill fight. We haven't seen strong data on the nukes. We recently saw encouraging efficacy from RGLS, but we also saw some very worrisome AE's in small numbers. Perhaps worse, there wasn't much comment on them, to the best of my knowledge.
If these 3 HCV programs were to be problematic or less than successful it could turn into a race between GILD and ABBV. I think we may see the viability of some of these programs this year.
I think we are starting to see that development in HCV could soon end as the cure rates climb and prices drift downward. Whoever is on top may stay on top