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Protalix BioTherapeutics Announces FDA Approval to Operate its Current Facility as 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
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms “anticipate,” “believe,” “estimate,” “expect,” “plan” and “intend” and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause material differences include, among others: failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and lack of sufficient funding to finance clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to the amount and sufficiency of our cash and cash equivalents; risks related to the successful conclusion of our negotiations with the