The drug is an enzyme replacement therapy for type 1 Gaucher’s disease that was developed by Israel-based Protalix Biotherapies in partnership with Pfizer. It is one of only three approved medicines along with Shire’s Vpriv and Sanofi’s Cerezyme.
The salient difference between Elelyso and the other products is that it is manufactured in plant cells, specifically genetically engineered carrot cells, which was the key factor in the US Orthodox Union’s (OU) decision to certify it as kosher.
In contrast, the Shire and Sanofi products are produced using human fibroblasts and Chinese hamster ovary cells (CHO), respectively, meaning that they are unlikely to be granted the same status.
This is potentially significant given that, although there are only around 10,000 sufferers of Gaucher's disease worldwide, the incidence of the condition is around 100 times higher in people of Ashkenazi Jewish descent than in the general population.
Rabbi Menachem Genack, CEO of OU Kosher said: "Gaucher’s disease and its treatment options are an important issue in the Jewish community, as one in 14 Ashkenazi Jews are carriers for the disease compared to the general population.”
He added that: "In a life or death situation, Jewish law clearly sets aside the kosher status of a prescription medicine, but in other cases, it is preferable and sometimes recommended that a medicine be certified kosher.”
When it was launched in 2012 Elelyso cost $150,00 per patient per year which was significantly less than either the $200,000 Sanofi charged for Cerezyme, then the most expensive drug in the world, or the $170,000 price tag Shire put on Vpriv.
Whether the new kosher status combined with its lower price will help Elelyso win market share from Cerezyme or Vpriv remains to be seen.
A spokeswoman for Sanofi’s Genzyme subsidiary told in-Pharmatechnologist.com that: “We do not intend to see kosher status for Cerezyme.”
A Shire spokeswoman told us that: "Shire’s Gaucher treatment, VPRIV, does not have a kosher certification. With Gaucher disease impacting a large percentage of the Ashkenazi Jewish population, Shire would be open to look into this based on patient needs."
She added that the drug "is produced from a human cell line, without any materials form animals. It is the only approved Gaucher enzyme replacement therapy (ERT) that has the same amino acid sequence as the naturally occurring enzyme."
Th Gaucher's disease market could soon become more crowded. European and US regulators are currently assessing Sanofi’s oral Gaucher’s disease drug candidate, Cerdelga.