Protalix Biotherapeutics, Inc., (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, today announced an exclusive worldwide license agreement with SarcoMed USA Inc. for alidornase alfa, or PRX–110, for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery. Alidornase alfa is the Company’s proprietary chemically-modified plant cell–expressed recombinant form of human deoxyribonuclease I (DNase I), administered through inhalation. SarcoMed USA was formed in 2017 to investigate if a novel DNase 1 compound could influence the chronic pulmonary inflammation seen in pulmonary sarcoidosis patients.
Under the terms of the agreement, SarcoMed will be responsible for the identification and selection of pharmaceutical candidates under the license, and the clinical research and development of such candidates. Protalix is entitled to an initial cash payment of $3.5 million, subject to certain conditions, and to additional regulatory and commercial milestone payments and tiered royalties on net sales of products that are commercialized under the license agreement. In addition to the foregoing, the parties have agreed to commence negotiation of clinical and commercial supply agreements for alidornase alfa. As part of the arrangement, the parties have agreed to negotiate and sign a supply agreement within 60 days of the execution of the license agreement, and SarcoMed USA has the right to terminate the license agreement if the parties do not successfully do so.
“We are pleased to partner with SarcoMed USA, a privately-held company led by professionals with a wealth of experience in the research and development of pharmaceuticals,” commented Dror Bashan, Protalix’s President and Chief Executive Officer. “Most patients with pulmonary sarcoidosis do not show symptoms and do not realize they have the disease until it has progressed to later stages. Currently available treatment options vary significantly from patient to patient, and the treatments generally either control symptoms or improve the patient’s lung function. A treatment that both controls symptoms and improves the patient’s lung function is needed in the market today. We believe PRX-110 has the potential to be an exciting treatment option. Also, we believe this transaction further validates and enhances our development pipeline of drug candidates that can be produced through ProCellEx.”
On July 21, 2020, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for alidornase alfa for the treatment of sarcoidosis. The FDA grants Orphan Drug Designation to drugs or biologics intended to treat or prevent rare diseases or conditions that affect fewer than 200,000 individuals in the United States.
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Source: Biospace