Protalix BioTherapeutics, Inc.
) 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
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
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
) 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
) have a presence in the Gaucher disease market.
Currently Protalix carries a Zacks Rank #3 (Hold).
Comparatively companies like
) look better positioned, carrying a Zacks Rank #1 (Strong
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