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. I know it's a different case but I don't have a strong faith in their patent lawyers). KMDA might fail in the clinic but this could indicate that inhaled delivery isn't working. Kind of a catch 22...
Indeed, I think Enbrel is well protected by the 'submarine' patent in the US for many more years. Besides, there are several companies developing biosimilar versions of Enbrel so seems too late and crowded. However, PLX is now talking about an orally administered anti-TNF and that's a different story.
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.
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