Protalix Biotherapeutics Announces Feasibility Study with Kirin Holdings on the Production of a Novel Complex Protein
CARMIEL, Israel, March 16, 2020 /PRNewswire/ -- 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, announced today that it has agreed to conduct a feasibility study with Kirin Holdings Company, Limited (Kirin) to evaluate the production of a novel complex protein utilizing ProCellEx®. Kirin will provide research funding for Protalix scientists to conduct cell line engineering and protein expression studies on the target protein.
Upon successful completion of the study, Kirin and Protalix anticipate holding discussions regarding the licensing of the ProCellEx technology and expression cells to Kirin for the continued development of the product.
"We are pleased to announce this project with Kirin, which marks the start of a positive new relationship between our two companies," said Dror Bashan, President and Chief Executive Officer of Protalix. "This new study provides Protalix with another great opportunity to apply our scientific expertise and our proprietary ProCellEx protein expression technology in the study and production of a new and novel complex protein. We look forward to working with the scientists at Kirin on this exciting new project."
"The ProCellEx platform is of significant strategic interest for Kirin, and our advanced expertise in plant cell culture technology aligns well with their overall corporate vision," continued Mr. Bashan. "We look forward to the success of this feasibility study, and to the possibility of further collaboration with Kirin in their pursuit of creating a more prosperous world for future generations."
About Protalix BioTherapeutics, Inc.
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 was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.
Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.
Protalix's development pipeline consists of proprietary, potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α‑Galactosidase‑A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.
About Kirin Holdings Company, Ltd.
Aiming to become a global leader in creating shared value (CSV), the Kirin Group is striving to create value in business domain spanning from food & beverages to pharmaceuticals under its long-term management vision, Kirin Group Vision 2027. Kirin brings joy to society by crafting food and healthcare products inspired by the blessings of nature and the insights of our customers.
For more information, visit the Kirin website at https://www.kirinholdings.co.jp/english/
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 "expect," "anticipate," "believe," "estimate," "project," "plan," "should" 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 and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. 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: risk that the feasibility study will not produce the anticipated results; risks related to the progress of our research and development efforts; risks related to our ability to maintain and manage our relationship with any collaborator or partner; risks related to the amount of our future revenues and expenditures; our dependence on performance by third party providers of services and supplies; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Chuck Padala, Managing Director
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SOURCE Protalix BioTherapeutics, Inc.