Parma (Italy) -- Chiesi Farmaceutici S.p.A. (Chiesi), announces an Ex-US license and collaboration agreement with Protalix BioTherapeutics, Inc. a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®, for pegunigalsidase alfa, orPRX-102, the Company’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.
“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 United States,” commented Moshe Manor, Protalix’s President and Chief Executive Officer. “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 for the development costs of PRX-102 and general corporate purposes, while maintaining full rights to the U.S. market.”
Under the terms of the agreement, Protalix has licensed PRX-102 to Chiesi for all markets outside of the United States, and Protalix will receive an upfront payment of $25 million from Chiesi in consideration for and as reimbursement of the past costs sustained by Protalix and additional payments up to$25 million in future development costs. Protalix is also eligible to receive an additional up to $320 million, in the aggregate, in regulatory and commercial milestone payments, and additional tiered double-digit payments based on Chiesi net sales as consideration for product supply.
“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,” said Ugo Di Francesco, Chiesi’s CEO. “PRX-102 complements our existing product portfolio in rare diseases and underscores our commitment to bringing novel therapeutics to patients across the globe.”
Additional details regarding the collaboration can be found in Protalix's Form 8-K to be filed with the Securities and Exchange Commission.
About Chiesi Farmaceutici S.p.A.
Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused Healthcare Group, with over 80 years of experience in the pharmaceutical industry. Chiesi researches, develops and markets innovative drugs in the respiratory therapeutics, specialist medicine and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and integrated with 6 other key R&D groups in France, the USA, the UK, Sweden and Denmark to advance Chiesi's pre-clinical, clinical and registration programmes. Chiesi employs nearly 5,000 people.
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’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 U.S. Food and Drug Administration (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 includes the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human alpha-GAL-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.