Protalix is leveraging internally developed capabilities to improve biologic dynamics (e.g., glycosylation, half-life extension) of a protein combined with the multiple unique advantages of its proprietary ProCellEx® protein expression system, including advanced genetic engineering technology and plant cell-based protein expression methods, to develop a pipeline of novel, next-generation or clinically superior versions of recombinant therapeutic proteins. Significant advantages of ProCellEx® over existing expression systems of mammalian, bacterial, yeast and transgenic cell-based expression technologies, include biologic optimization, the ability to penetrate certain patent-protected markets, a broad range of expression capabilities, significantly lower capital and production costs, elimination of the risk of viral transmission or infection by mammalian components, and the potential ability to administer active therapeutic proteins and vaccines orally.
We believe that all these elements along with our success in bringing Elelyso® (taliglucerase alfa for injection) through clinical trials, regulatory agency approval, and into the market demonstrates a full set of capabilities which make Protalix a partner of choice for other complex therapeutic proteins.
Protalix is interested in considering partnership opportunities on biobetter and novel therapeutic proteins and vaccines as well as exploring oral delivery of biotherapeutics and vaccines by utilizing ProCellEx® technology, in addition to collaborations relating to Protalix’s current pipeline of proprietary therapeutic proteins.
For partnership inquiries, please contact:
Vice President Business Development
In October 2017, Protalix entered into a license and collaboration agreement with Chiesi Farmaceutici S.p.A., with respect to the commercialization of pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease. Under this agreement, Protalix granted Chiesi the exclusive right to commercialize pegunigalsidase alfa for all markets outside of the United States.
In July 2018, Protalix announced the expansion of its partnership with Chiesi. Protalix and Chiesi entered into an exclusive U.S. license and supply agreement under which Protalix granted to Chiesi the United States rights for the development and commercialization of pegunigalsidase alfa. As a result, Chiesi will serve as Protalix’s global partner to support the shared goal of bringing the next generation enzyme replacement therapy to the global Fabry patient community.
Protalix continues to be the manufacturer of pegunigalsidase alfa for clinical development purposes and commercial purposes after marketing approvals.
In October 2015, we entered into an amended agreement with our commercialization partner for taliglucerase alfa, Pfizer Inc., pursuant to which we licensed to Pfizer the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where we retain full rights. Our original agreement with Pfizer, which was entered into in November 2009, provided that we share with Pfizer revenues and expenses for the development and commercialization of Elelyso on a 60%/40% basis globally, excluding Israel and Brazil. The amended agreement effectively represents the sale of our share in the collaboration agreement to Pfizer. As part of the sale, we agreed to transfer our rights to Elelyso in Israel to Pfizer, and retained such rights in Brazil.
Fundação Oswaldo Cruz
In June 2013, Protalix entered into a supply and technology transfer agreement with Fundação Oswaldo Cruz, an arm of the Brazilian Ministry of Health. The technology transfer is intended to transfer to Fiocruz the capacity and skills required for the Brazilian government to construct its own manufacturing facility, at its sole expense, and to produce a sustainable, high quality and cost effective supply of alfataliglicerase (taliglucerase alfa).