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Update on Protalix Gaucher Study

Zacks Equity Research

Protalix BioTherapeutics, Inc. (PLX) recently announced the treatment of the first patient in a phase I study of PRX-112 or oral glucocerebrosidase enzyme (:GCD). Oral GCD is being developed for the treatment of Gaucher disease. The phase I study is expected to end in the third quarter of 2013.

We note that Protalix already has an approved Gaucher disease product in its portfolio. Elelyso, an enzyme replacement therapy (:ERT), gained approval in the US in May 2012 for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease.

The product is approved in other countries as well including Israel, Brazil and Uruguay. However, as far as EU approval is concerned, the European Commission refused marketing authorization for Elelyso in Nov 2012.

In addition to its Gaucher disease candidate, Protalix is also developing PRX-102 for the treatment of Fabry disease. In Dec 2012, the company announced the treatment of the first patient in a phase I/II clinical study of Fabry patients with PRX-102.

In early 2012, the European Medicines Agency (:EMA)'s Committee for Medicinal Products for Human Use (CHMP) had expressed its inability to recommend marketing authorization for Elelyso because of the presence of Shire plc’s (SHPG) Vpriv (velaglucerase alfa) in the market. We remind investors that Vpriv received orphan drug status in the EU and has 10 years of marketing exclusivity for Gaucher disease since Aug 2010.

We note that companies like Sanofi (SNY) have a presence in the Gaucher disease market.

Currently Protalix carries a Zacks Rank #3 (Hold). Comparatively companies like Cytokinetics, Inc. (CYTK) look better positioned, carrying a Zacks Rank #1 (Strong Buy).

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