$PLX MASSIVE BREAKOUT POTENTIAL IN PROTALIX BIO.

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Protalix BioTherapeutics and Chiesi Farmaceutici S.p.A to Apply for Accelerated Approval of pegunigalsidase alfa for the Treatment of Fabry Disease in the United States
"We are very excited to be one step closer to an approved product to help a patient population that desperately needs a better option than those currently available on the market. This regulatory approval path is a significant achievement as it means that we can start the application process and potentially attain market approval significantly earlier than the initial plan of data from our ongoing phase III BALANCE clinical trial. We plan to continue the BALANCE study to further strengthen the profile of pegunigalsidase alfa," commented Moshe Manor, Protalix's President and Chief Executive Officer. "Approval will depend on the formal FDA review, but based on communications with the agency, Protalix remains optimistic that the FDA will approve pegunigalsidase alfa on the accelerated basis."


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COMPANY PROFILE
Protalix Biotherapeutics, Inc. engages in the development and commercialization of recombinant therapeutic proteins based on ProCellEx plant cell based expression system. It offers Taliglucerase alfa injections under the brand name Elelyso, an enzyme replacement therapy for Gaucher disease. The company's drugs also include Oral Glucocerebrosidase for potential treatment of Gaucher disease; therapeutic proteins for Fabry disease, and immune diseases such as rheumatoid, psoriatic and juvenile idiopathic arthritis, ankylosing, spondylitis, and plaque psoriasis; and protein for biodefense and other indications. Protalix Biotherapeutics was founded on November 30, 1995 and is headquartered in Carmiel, Israel.