Replies to post #212959 on Biotech Values

[mcbio]

FGEN -

The one thing I wonder about and perhaps explains why liver fibrosis (NASH) is slow tracted is IP. IPF, DMD and their subset of PC would all qualify as Orphan indications so they get the 7/10 exclusivity. Some of the oncology indications I'm not so sure about.

I think that's a great point on NASH.

I still think they fit well in GILD's sweet spot. "Derisked" (as much as is possible for IPF) Phase 2 asset ready for P3 for them to put input. Seems actually a lot like Filgotinib at stage and potential for multiple indications.

At least its pretty clear Neff will partner and it sounded like sooner rather than later too.
If the data have no warts and look as good as they seem I'd imagine Roche and BI should be interested. BMY in addition to the oncology angle have done several fibrosis deals so imagine they should have interest too.

GILD certainly seems to have a fibrotic focus but nothing specific in IPF I don't believe. And of course no PDL1 (or PD-1) but doesn't mean a deal couldn't happen.

I forgot to mention the other important point about FGEN actually running the combo trial combining pamrevlumab with each of pirfenidone and nintedanib. So, certainly seems like it would make sense for Roche and/or BI to have potential interest. Given that Roche also has the PDL1 that Neff referenced, my gut would still be that Roche would make the most sense as a potential partner. Regardless of who the potential partner may be, I just hope FGEN can negotiate really good terms. Neff referenced an interest in U.S. and China rights so I'm assuming that means FGEN may want a co-promote option in those territories.

[biomaven0]

>FGEN IP

Worth noting that Neff mentioned a new patent filing related to Cmin. Whether that might hold up or not I have no idea.

This isn't a great candidate for a biosimilar - the inherently high COGS will cut into margins, not to mention the start-up costs for a huge plant.

FGEN has also been burnt before on both kidney and liver fibrosis - the endpoints are hard, although you could now piggyback off the other NASH players. Those early FGEN trials were almost certainly significantly under-dosed as well.

For example, this was run at 5 and 10mg/kg:

https://clinicaltrials.gov/ct2/show/NCT00754143?term=fg-3019&draw=1&rank=6