Protalix/Pfizer's Elelyso Approved in Pediatric Patients

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ProtalixBioTherapeutics, Inc. (PLX) and partner Pfizer Inc. (PFE) announced that the FDA has approved Elelyso injection for pediatric patients suffering from type I Gaucher disease. Protalix’s shares jumped 8.3% on the news. Protalix has a worldwide partnership for the commercialization of Elelyso with Pfizer.

We note that Elelyso was already approved in the U.S. as an enzyme replacement therapy (:ERT), for the long-term treatment of adults diagnosed with type I Gaucher disease. Elelyso’s label also carries some important safety information.

Elelyso is recommended for treatment-naïve adults and pediatric patients (aged four years or above) at a dose of 60 units/kg of body weight to be administered every other week as a 60- to 120-minute intravenous infusion.

Apart from Elelyso, Protalix also has PRX-112 (oral glucocerebrosidase − GCD) being developed for the treatment of Gaucher disease. PRX-112 is currently being evaluated in a phase IIa study (read more: Protalix Drug in Phase IIa Study for Gaucher Disease).

Our Take

Elelyso’s U.S. approval for pediatric patients with type I Gaucher disease comes as a huge boost to Protalix. The label expansion will boost the drug’s sales. Moreover, the company’s portfolio will be further strengthened by the successful development of PRX-112.

Currently, Shire’s (SHPG) Vpriv is approved for the treatment of Gaucher disease. Several other companies are also looking to enter the Gaucher disease market.

Protalix carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Gilead Sciences Inc. (GILD), carrying a Zacks Rank #1 (Strong Buy).

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