Pro­tal­ix files BLA to com­pete with Sanofi Gen­zyme; Rally­bio col­lects an­oth­er Alex­ion alum

Pro­tal­ix Bio­Ther­a­peu­tics has filed a BLA for their Fab­ry Dis­ease treat­ment, pe­gu­ni­gal­si­dase al­fa. The drug is a re­com­bi­nant en­zyme grown in plant cell cul­tures and de­signed to sup­ple­ment the lyso­so­mal en­zyme that is de­fi­cient in pa­tients with the ge­net­ic dis­or­der. Chiesi Glob­al Rare Dis­eases has signed up to com­mer­cial­ize the drug, in a deal that’s worth up to $760 mil­lion. A phase III study showed the Is­raeli biotech’s drug led to much high­er con­cen­tra­tion of en­zyme than Fab­razyme, the long­time stan­dard-of-care from Sanofi Gen­zyme.

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