biOasis Technologies Ord Shs BIOAF

FDA Approval of PRX-102 (Elfabrio)

[Boomskid]

Protalix and Chiesi have announced that their enzyme replacement therapy for Fabry disease, PRX-102, now called Elfabrio, has been approved by the FDA. You can find a cellphone-friendly version of the press release << here >>.

 

There has been a question for almost three years about whether Fabry disease is one of the four secret lysosomal diseases that Bioasis sold to Chiesi for US$750,000 each. Bioasis and xB3 have never been mentioned by Chiesi, and the four LSDs have remained secret.

 

We have speculated that Fabry disease would seem to be a logical choice for Chiesi/Protalix to advance as one of the four LSDs. We’ve also speculated that PRX-102 (Elfabrio) could be the payload for xB3 in a BBB-penetrating drug. We have discussed the possibility that Chiesi may be holding the xB3/LSD project back until PRX-102 has been approved by the FDA. It’s possible, maybe likely, that Chiesi/Protalix would not want to advance an unapproved drug as an xB3 payload.

 

So now Chiesi has FDA approval of PRX-102. My question is whether FDA approval of PRX-102 (Elfabrio) might trigger a milestone payment under the Chiesi/ Bioasis agreement. That agreement was described by Bioasis as having trigger points for developmental, regulatory and commercial milestone payments. With the approval of PRX-102, we have a regulatory event and, possibly, a developmental event if Chiesi and Protalix decide to advance xB3-Elfabrio.

 

I don’t have much in the way of expectations with regard to this, but hope springs eternal.

 

I love the name “Elfabrio.” It’s a construct of interest.

 

“El” means “the” (the masculine version of "the").

“fab” can be considered to be derived from both “Fabry” and “fabulous”.

And “brio”, in addition to containing two letters from “Fabry”,  is a noun meaning vigour or heightened vivacity.

 

And, of course, there’s always the Fabio Lanzoni connection.

 

So, ummm, did those Chiesi/Protalix marketing gurus know what they were naming PRX-102 or was the humour completely serendipitous?

Elfabrio - the highly macho and vigourous ERT for Fabry disease. Love it.

So, let's see a milestone payment. Today would be nice.

jd