Israeli company Protalix Biotherapeutics Inc. (NYSE:PLX; TASE: PLX) today announced a collaboration agreement with Chiesi Farmaceutici for pegunigalsidase alfa, or PRX-102, worth up to $370 million. Based in Karmiel, 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.
Under the terms of the agreement, Protalix has licensed PRX-102 to Chiesi for all markets outside of the US, and Protalix will receive an upfront payment of $25 million from Chiesi and additional payments of up to $25 million in development costs, capped at $10 million per year. Protalix is also eligible to receive an additional up to $320 million, in regulatory and commercial milestone payments, and tiered royalties ranging from 15% to 35% on net sales. Protalix will continue to be the manufacturer of PRX-102 for clinical development purposes and commercial purposes after marketing approvals.
Protalix's chemically modified version of the recombinant protein alpha-Galactosidase-A protein that is currently being evaluated in phase III clinical trials for the treatment of Fabry disease. PRX-102 has demonstrated a significantly enhanced circulatory half-life and higher enzyme activity in the target organs affected by Fabry disease when compared to currently available versions of the molecule, and strong positive safety and efficacy data from its completed phase I/II clinical trial.
Protalix president and CEO Moshe Manor said, "We are pleased to partner with Chiesi, an international privately-held company with more than 80 years of experience and a strong focus on the development and commercialization of innovative medicines with commercial presence in virtually all markets outside the US. The $50 million commitment made by Chiesi before any of our ongoing phase III clinical trial results read-out is not only a significant non-dilutive cash infusion for us, it also represents Chiesi’s commitment to the Fabry market in general and our PRX-102 program in particular. With this transaction, we have secured significant and important funding while maintaining full rights to PRX-102 in the US market."
Chiesi CEO Ugo Di Francesco said, "With revenues of approximately $1.8 billion, the Chiesi Group is among the top 50 pharmaceutical companies in the world. By combining the respective strengths of Chiesi and Protalix to advance PRX-102, we look forward to bringing a novel, differentiated therapeutic option to patients suffering from Fabry disease who have a true need for an alternative treatment with an improved safety and efficacy profile. PRX-102 complements our existing product portfolio in rare diseases and underscores our commitment to bringing novel therapeutics to patients across the globe."
Published by Globes [online], Israel business news - www.globes-online.com - on October 18, 2017
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