22 May 2014 - Protalix BioTherapeutics, Inc. announced today that the Australian Therapeutic Goods Administration (TGA) has granted regulatory approval to Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy for both adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease associated with at least one of the following: splenomegaly, hepatomegaly, anemia, thrombocytopenia. Elelsyo will be marketed in Australia by Pfizer Inc., the Company's commercialization partner.

Taliglucerase alfa was approved by the U.S. Food and Drug Administration in May 2012 for adults with Type 1 Gaucher disease. With this TGA decision, the drug is now licensed in ten countries and further regulatory filings are underway.

"Australia is the first country in which Elelyso is indicated for both adult and pediatric patients as the pediatric trials were completed concurrently with the commencement of the TGA's review," said Dr. Einat Brill Almon, Protalix's Senior Vice President, Product Development. "In other countries where Elelyso is currently approved, label expansions are being filed to include pediatric patients as well."

For more details, go to: http://phx.corporate-ir.net/phoenix.zhtml?c=101161&p=irol-newsArticle&ID=1933504&highlight=

The PBAC considered a submission to list Elelyso on the LSDP in March 2012; its final outcome (rejection) was only made public recently.  There is no associated PBAC Public Summary Document.