Item 8.01. Other Events
On March 18, 2013, Protalix BioTherapeutics, Inc. and Pfizer Inc. announced that
the Brazilian National Health Surveillance Agency (ANVISA, Agencia Nacional de
Vigilancia Sanitaria) has granted regulatory approval to UPLYSO™
(alphataliglicerase) for the long-term enzyme replacement therapy for adults
with a confirmed diagnosis of Type I Gaucher disease. Gaucher disease is a rare
lysosomal storage disorder that affects approximately 10,000 people worldwide.
UPLYSO is known as ELELYSO™ (taliglucerase alfa) outside of Latin America. A
copy of the press release is filed as Exhibit 99.1.
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