Replies to post #191218 on Biotech Values

[dewophile]

In the open label fibrosis did correlate w fvc. The problem w including the very sick is they die before you get enough duration of drug to see effect I think that's why itmn also didn't allow these PTS in their ph 3. Shifting geRs since you seem very familiar w this space curious what you think of PLI they have an oral drug that acts in large part on Ctgf that may be entering the clinic also any other competitiors. I bought in for the anemia drug but like you think the really big money could be if the ipf drug succeeds. As for first line I'm ok w combos I bet we see docs start combos of the FDA drugs already on market and to be a realist second line is likely where fgen looks to go first unless the data is stellar in the current trial

[ghmm]

IPF - Roche / FGEN:

Here is some interesting data on patients who have FVC decline of > 10% on Esbriet after 6 months and stay on.

http://www.medpagetoday.com/MeetingCoverage/ATS/51613

Among patients in the pirfenidone groups, 58.8% had no further decline in FVC, compared with 38.2% of those in the placebo groups (P=0.059).

Results in an on-treatment analysis were similar, finding one patient in the pirfenidone group and 15 in the placebo group having a further 10% or more decline or death, for a relative difference of 83.3% (P=0.032), Nathan reported. In this analysis, there were no deaths in the pirfenidone group and 10 in the placebo group during the 6 months after the initial decline, with a relative difference of 100% (P=0.056).
...
"FVC may not be the whole story. This is a very complex disease," he said.

From Roche's Q1 results Esbriet seems to be selling extremely well in the US. There is definitely room for other agents and while FGEN may not have news per-sa I wouldn't rule out a deal here. My one gripe with FGEN is they've moved extremely slow in IPF and while I think they don't need to partner this I wonder if someone could help speed this up.