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Why It Matters That Protalix BioTherapeutics’ Orphan Drug Elelyso For Gaucher Disease Receives Approval In Israel ?

September 30, 2012

       Why does it matter that Protalix BioTherapeutics’ Orphan Drug Elelyso for Gaucher Disease receives approval in Israel ?

       As discussed in the Orphan Druganaut September 27, 2012 Blog Post, Elelyso receives marketing authorization for the treatment of adults with Type 1 Gaucher Disease from the Israeli Ministry of Health.  Elelyso is the 1st plan cell-based biopharmaceutical receiving approval for marketing by the Israeli Ministry of Health.  

        Per The Motley Fool’s September 28, 2012 article titled, “A Home Run Drug in the Holy Land”, “Protalix BioTherapeutics just hit a home run” when orphan drug Elelyso received marketing authorization in its home country for several reasons :

1)  Protalix Therapeutics owns full rights to Elelyso in Israel. Pfizer bought “exclusive license to market the drug worldwide …. Protalix receives 40% of net profits from Pfizer’s sales outside of Israel”

2)  Gaucher Disease affects only an estimated 10,000 worlwide. The most common form of Gaucher Disease is Type 1, which “occurs at higher frequencies in individuals with Ashkenazi Jewish ancestry”   

       To recap the history of Elelyso :

1)  In May 2012, receives FDA approval for sale in the US 

2)  In June 2012, EMA’s CHMP recommends against approval for sale in Europe, because orphan market exclusivity was previously granted to Shire plc’s Vpriv

3)  Pfizer and Protalix BioTherapeutics has also filed marketing authorization applications in Brazil and Australia


CNNMoney September 24, 2012 Article  

Copyright © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.

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