Replies to post #162925 on Biotech Values

[iwfal]

PLX -

Yes, if KMDA gets approved with their inhaled enzyme, PLX will have to try and break KMDA's orphan exclusivity and I don't think chances are very good (recall they tried this with Shire's orphan exclusivity in EU in Gaucher and failed.

It would be interesting to watch the regulatory and court decisions to see how similar the competing enzymes have to be before they are judged to be "the same chemical entity" and thus disallowed under orphan exclusivity.

1) Same active-in-cell ingredient is the only thing that matters? - regardless of delivery mechanism (which is, or course, a large part of the trick in enzyme treatments)?


2) Will different glycosylation count as being different? ...

Given the likely uncertainty/risk I am surprised that companies aren't being more careful to try to be at least a little different on the final enzyme - e.g. start with a chimp variant.

[mcbio]

PLX

Yes, I still have some shares left from a very long position I kept because of the Fabry drug and now I like the DNase candidate too.

Thanks for the detailed response. Very helpful, as always. I'm at least putting PLX on my watchlist as I could use a small-cap name in the biosimilar/biobetter space. Just don't know if I'll ever be in position to take a position given some other priorities. But, I do agree with jq's prior post that PLX and MNTA would be the names to consider here in this space.