Replies to post #171496 on Biotech Values

[DewDiligence]

Typo correction to ‘ION’ musings in #msg-95103023; the final paragraph should read:

…nothing in GILD’s data release today warrants a change to my ENTA valuation model in #msg-94993406. In that model, I give GILD a 62/38 advantage in GT1 market share starting in 2015, and I think such a split is still reasonable, particularly if ABBV/ENTA compete aggressively on price.

[ciotera]

Re: ION results

Isn't it a little harsh to think that the 8-week regimen is out the window because of a 3.7% difference in SVR (1.4% if we stay within ION-3)?

And is RBV and all that comes with it really absolutely needed for the 2.8% extra that it brings in ION-2?

Your threshold for significant/meaningful appears very low in the above, esp. considering how little importance you attach to the extra 5.5% from going to 24 weeks in ION-2. Why the double standard? Cost implications cannot be the explanation - as you pointed out many times, GILD can do a cap program instead of charging double for the 24 week durations.

Again, are we reading too much into numerical differences based on N=100/200 trial arms? Are these differences statistically significant? Are they clinically meaningful? Or can we simply conclude from all this that 8 weeks is good enough for naïves and 12 weeks is good enough for experienced and you don't need RBV with either?

PS: I do agree that once we know sub-population data (cirrhotics, subtype, HIV, etc.) then some patients may need longer durations.



Dew-pls delete earlier duplicate post

[ronpopeil]

Thanks! Good info

[DewDiligence]

Addendum: All talk that GILD was malevolent for not pursuing a Sovaldi + Daclatasvir partnership with BMY should immediately cease.

[oc631]

The 24-week arms of ION-1 haven’t been reported yet, but they are all but meaningless from a commercial standpoint because no third-party payers will fund 24 weeks of treatment when 12 weeks of treatment produces an SVR12 rate of more than 97%. (The possible exception is cirrhotic patients, but GILD hasn’t yet disclosed the subgroup data for cirrhotics.)

It hasn't been disclosed yet but the pricing strategy for Sofo/Ledi will most certainly be based on a treatment duration basis. Like Sofo/Riba in GT2/GT3. With this in mind, the reason 24-week dosing is meaningless (as you state) is a result of GILD's pricing strategy. GILD claims in their PR that the majority of tolerability issues come from ribavirin use. If true there would be doctors and patients willing to take the Sofo/Ledi combo for 24-weeks (by choice) due to the trend in added efficacy. Remember also that the data we looked at today is cherry-picked clinical data that will not be reproduced in the real world setting. This makes the longer dosing, efficacy trend a meaningful stat.

[DewDiligence]

Copy editor needed immediately:

http://www.bizjournals.com/boston/blog/bioflash/2013/12/gilead-says-it-will-target-the-same.html

Gilead said today that based on promising data from a late-stage study of its drug, Sovaldi, it plans to apply for U.S. approval by the end of March for the drug as part of a regiment to treat hepatitis C genotype 1…

… Enanta’s stock fell double digits today on the news coming out of Gilead…

…Enanta is still the most successful of all the local biotechs that went public in 2013, with its stock price more than doubling since its March IPO.

At least the final paragraph is error-free, LOL.