Protalix BioTherapeutics Inc Dossier
Qualitative Analysis
Business overview
Protalix BioTherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative recombinant therapeutic proteins for rare diseases. The company utilizes its proprietary, commercial-scale ProCellEx plant cell-based protein expression system to express recombinant proteins, representing a pioneering method in the industry. Protalix has successfully brought two enzyme replacement therapies to market: Elelyso (taliglucerase alfa) for Gaucher disease, marketed globally with Pfizer and Fiocruz, and Elfabrio (pegunigalsidase alfa) for Fabry disease, commercialized in partnership with Chiesi Global Rare Diseases.
Research as of 19 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Maximizing the commercial potential of Elfabrio (pegunigalsidase alfa) for Fabry disease in partnership with Chiesi. This includes leveraging the newly approved 2 mg/kg every-four-weeks (E4W) dosing regimen in the European Union and the United Kingdom to reduce patient treatment burden and capture a projected 15% to 20% share of the global Fabry market by 2031.
Expected impact: Drives long-term recurring product supply revenue and potential commercial milestones, strengthening the company's financial foundation.
Advancing PRX-115, a plant cell-expressed recombinant PEGylated uricase, through clinical development as a potential best-in-class therapy for uncontrolled gout.
Expected impact: Establishes a third proprietary molecule toward commercialization, targeting a high-need, high-value indication.
Sharpening the strategic focus on rare kidney diseases to build a robust renal pipeline through internal innovation and strategic partnerships. This includes advancing PRX-119 (a long-acting DNase I for inflammation and fibrosis) and discovering novel antisense oligonucleotide (ASO) therapies.
Expected impact: Broadens the pipeline into RNA-based technologies and rare kidney indications, creating long-term pipeline optionality.
Mergers, Acquisitions & Partnerships
Recent deals and strategic collaborations
Strategic Partnerships
Chiesi holds the exclusive rights to develop and commercialize Elfabrio (PRX-102) globally. Protalix acts as the manufacturer, receiving product supply revenues, tiered royalties (15% to 40%), and milestone payments.
Terms: Includes upfront payments and development cost reimbursements of $95 million, and up to $1.08 billion in potential regulatory and commercial milestones across the Ex-US and US agreements, plus tiered royalties ranging from 15% to 40% on net sales.
Partnership to discover novel antisense oligonucleotide (ASO) therapies against multiple targets for rare renal indications, combining Protalix's rare disease expertise with Secarna's AI-powered OligoCreator platform.
Terms: Protalix pays for the collaborative research and holds an exclusive option to license active compounds. The agreement includes minimal development milestones and royalty-bearing terms upon commercialization.
Pfizer holds the worldwide development and commercialization rights to Elelyso (taliglucerase alfa) for Gaucher disease, excluding Brazil where Protalix retains full commercial rights.
Terms: Protalix sold its share in the original collaboration to Pfizer for $36 million in cash in 2015 (with Pfizer also making a $10 million equity investment). Protalix continues to manufacture and supply the drug substance to Pfizer.