Protalix Biotherapeutics Inc (NYSEMKT:PLX) announced that a Supplemental New Drug Application (sNDA) submitted to the U.S. Food and Drug Administration (FDA) has been approved by the FDA. Approval of the sNDA allows the Company to convert its manufacturing facility in Carmiel, Israel, from a single dedicated product facility to a multi-product facility.
The facility’s current capacity can serve all of the Company’s current and expected commercial and clinical needs. The Company believes that conversion of the facility to a multi-product facility will serve the Company’s production needs for the anticipated commercialization of pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease together with the current and expected significant increase in the manufacturing of taliglucerase alfa, mainly due to the increased activities in Brazil. The Company expects that the conversion will allow the Company to realize potentially significant operational savings as it progresses towards the anticipated commercialization of pegunigalsidase alfa.
“We have been producing drug substance for our clinical trials of pegunigalsidase alfa in our facility and have already upgraded our manufacturing facility to become a multi-product facility to support the potential manufacturing of both pegunigalsidase alfa and taliglucerase alfa in a commercial scale,” said Moshe Manor, Protalix’s President and Chief Executive Officer. “Given the unique aspects of our ProCellEx® protein expression system, the conversion of the facilities did not entail substantial additional capital expenditures and will allow us to use our capital resources more efficiently in the commercial production of pegunigalsidase alfa, if approved. We are excited to have reached this milestone in our progression towards the commercialization of pegunigalsidase alfa alongside the expected increase in activities in Brazil.”
Shares of Protalix are currently trading at $0.945, up $0.045 or 5.04%. PLX has a 1-year high of $1.51 and a 1-year low of $0.26. The stock’s 50-day moving average is $0.93 and its 200-day moving average is $0.80.
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. Its drug candidates 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.