Protalix BioTherapeutics
An Israeli biopharmaceutical company developing recombinant protein medicines through plant-cell expression technology.
Last updated August 24, 2026
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Overview
Protalix BioTherapeutics is an Israeli biopharmaceutical company focused on the discovery, development, manufacture, and commercialization of recombinant protein therapies produced in cultured plant cells. Founded in 1993 by plant biochemist Yoseph Shaaltiel, the company built its business around the ProCellEx platform, which uses genetically engineered plant cells as biological factories for producing complex therapeutic proteins. The approach is intended to provide a scalable alternative to mammalian-cell and other conventional manufacturing systems, while allowing the company to engineer proteins with characteristics suited to specific rare diseases. The company’s best-known product is taliglucerase alfa, marketed as Elelyso in the United States and as Uplyso in Brazil. The enzyme is produced using genetically modified carrot-cell cultures and is used as enzyme-replacement therapy for adults and children with type 1 Gaucher disease, a lysosomal storage disorder caused by deficient activity of glucocerebrosidase. The United States Food and Drug Administration approved taliglucerase alfa in May 2012, making it the first plant-cell-expressed pharmaceutical to receive FDA approval. Protalix granted Pfizer worldwide development and commercialization rights outside Brazil, while retaining commercial rights in Brazil. Brazilian regulators approved the product for adults in 2013 and later extended the indication to children. Protalix’s development strategy has extended beyond Gaucher disease. Its pipeline has included pegunigalsidase alfa, formerly designated PRX-102, a chemically modified and PEGylated recombinant alpha-galactosidase A for Fabry disease; alidornase alfa, formerly PRX-110, a modified recombinant DNase I intended for cystic fibrosis; OPRX-106, an orally administered plant-cell-expressed TNF receptor II-Fc fusion protein; and PRX-105, a recombinant human acetylcholinesterase investigated as a potential medical countermeasure against nerve agents. The products have occupied different stages of development, and not all have reached commercialization. The company began in northern Israel, initially operating from a warehouse in Kiryat Shemona, before establishing its principal operations in Karmiel. Its financing and corporate development included a 2005 private placement, a reverse merger with Orthodontix completed in December 2006, and a subsequent public offering and application for an American exchange listing. Protalix also formed development and commercial collaborations with Teva Pharmaceutical Industries and Pfizer. The company’s scientific advisory activities have included Nobel laureates Roger Kornberg and Aaron Ciechanover. Protalix is positioned as a specialist biotechnology company whose differentiation rests on plant-cell manufacturing, orphan-disease expertise, and the development of recombinant enzymes and related protein therapies. Its commercial identity is closely associated with Elelyso and with the broader effort to make plant-based production a viable platform for regulated biopharmaceutical manufacturing. The company remains a publicly traded Israeli biotechnology business with international development and commercialization ambitions.
History
Protalix BioTherapeutics was established in Israel in 1993 by Yoseph Shaaltiel, a scientist trained in plant biochemistry at the Weizmann Institute. Before founding the company, Shaaltiel had also served in the Biology Department of the Israel Defense Forces’ Biological and Chemical Center. Protalix’s founding premise was that cultured plant cells could be engineered to produce therapeutic proteins with appropriate biological activity and at commercially useful scale. In its early period, Protalix operated from a warehouse in Kiryat Shemona in northern Israel. The company developed the ProCellEx platform, based on genetically modified plant-cell cultures rather than whole plants. This approach became the foundation for its work on recombinant enzymes and other proteins. One early and significant investor was Phillip Frost, who later became associated with the company’s financing and corporate development. Protalix raised capital through a Series C preferred-stock private placement completed in July 2005. In December 2006, it became a public company through a reverse merger with Orthodontix, then an over-the-counter-listed company. The transaction was described as unusually large for a reverse merger and was followed by an effort to obtain a listing on the American Stock Exchange and a public offering of additional shares. During the same period, Protalix entered into a partnership with Teva Pharmaceutical Industries to develop two proteins. The company’s principal commercial breakthrough came through taliglucerase alfa, an enzyme produced in transgenic carrot-cell cultures for enzyme-replacement treatment of type 1 Gaucher disease. In 2009, Protalix entered a collaboration with Pfizer for development and commercialization of the product. The partnership gave Pfizer global rights outside Brazil, while Protalix retained rights in Brazil. Protalix also received recognition from Frost & Sullivan in 2009 for orphan-disease product innovation. Manufacturing and regulatory infrastructure became important milestones. In 2011, Protalix announced FDA approval of its Karmiel manufacturing facility. In May 2012, the FDA approved taliglucerase alfa under the Elelyso name for type 1 Gaucher disease. The product was notable as the first pharmaceutical produced through a plant-cell expression system to receive FDA approval. In Brazil, the product was marketed as Uplyso: ANVISA approved it for adults in March 2013 and expanded the approval to children in December 2016. After the approval of Elelyso, Protalix continued developing a pipeline centered on plant-cell-produced proteins. Pegunigalsidase alfa, also known as PRX-102, was designed as a chemically modified and PEGylated alpha-galactosidase A for Fabry disease. Alidornase alfa, formerly PRX-110, was engineered from recombinant human DNase I with the aim of resisting inhibition by actin and improving the handling of viscous pulmonary mucus in cystic fibrosis. Other programs included OPRX-106, an orally administered TNF receptor II-Fc fusion protein, and PRX-105, a recombinant acetylcholinesterase investigated as a countermeasure against nerve-agent exposure. The company’s scientific advisory profile has included chemistry Nobel laureates Roger Kornberg and Aaron Ciechanover. Protalix has consequently combined a commercial rare-disease franchise with a platform-oriented research identity. Its long-term differentiation has remained the application of plant-cell biology to regulated biopharmaceutical manufacturing, while its business development has relied on collaborations, licensing arrangements, public financing, and partnerships with larger pharmaceutical companies.
- 2016
Brazilian pediatric indication added
[1]Brazil extends the taliglucerase alfa authorization to children.
- 2013
Brazil approves Uplyso
[1]ANVISA authorizes taliglucerase alfa for adult Gaucher disease patients in Brazil.
- 2012
Elelyso receives U.S. approval
[1]The FDA approves taliglucerase alfa for type 1 Gaucher disease, establishing the company’s first commercial product.
- 2011
Karmiel facility receives FDA approval
[1]The FDA approves Protalix’s manufacturing facility in Karmiel, Israel.
- 2009
Pfizer collaboration for taliglucerase alfa
[1]Pfizer becomes Protalix’s development and commercialization partner for taliglucerase alfa outside Brazil.
- 2006
Reverse merger creates a public company
[1]Protalix completes a reverse merger with Orthodontix and begins its transition into a publicly traded biotechnology company.
- 2006
Teva development partnership
[1]Protalix enters a collaboration with Teva Pharmaceutical Industries for two protein-development programs.
- 2005
Series C financing closes
[1]Protalix completes a private placement of approximately $5.3 million in Series C preferred stock.
- 1993
Protalix is founded in Israel
[1]Yoseph Shaaltiel establishes Protalix to develop recombinant therapeutic proteins using plant-cell expression technology.
Products and positioning
A specialist biotechnology company using plant-cell expression to develop and manufacture recombinant protein therapies, with an emphasis on rare and inherited diseases.
Enzyme-replacement therapy · 2012
Elelyso
Elelyso is the U.S. brand name for taliglucerase alfa, a recombinant form of glucocerebrosidase produced in genetically modified carrot-cell cultures. It is used as enzyme-replacement therapy for adults and children with type 1 Gaucher disease. The FDA approved it in May 2012 as an orphan medicine. Pfizer commercializes the product in the United States and other territories under a collaboration with Protalix, while Protalix retains rights in Brazil.
Enzyme-replacement therapy · 2013
Uplyso
Uplyso is the Brazilian brand name for taliglucerase alfa. ANVISA approved the therapy for adults with Gaucher disease in 2013 and later extended the authorization to children. Brazil is a strategically important market for the product because Protalix retained commercial rights there rather than licensing them to Pfizer.
Investigational enzyme-replacement therapy
Pegunigalsidase alfa (PRX-102)
Pegunigalsidase alfa is a plant-cell-expressed recombinant alpha-galactosidase A that has been chemically modified and linked to PEG chains. Protalix developed the molecule for Fabry disease, an inherited lysosomal storage disorder. The modifications were intended to improve molecular stability and persistence compared with unmodified enzyme products. The program advanced into late-stage clinical development, but the supplied reference material does not establish its final regulatory or commercial status.
Investigational respiratory biologic
Alidornase alfa (PRX-110)
Alidornase alfa is a modified recombinant human DNase I produced through plant-cell expression. Protalix designed it to resist inhibition by actin and to reduce the viscosity of airway mucus in cystic fibrosis. The program was intended to improve a therapeutic mechanism already used in cystic-fibrosis care. Reference material reports encouraging clinical findings in 2017 but does not provide a final approval or commercialization outcome.
Investigational oral biologic
OPRX-106
OPRX-106 is a plant-cell-expressed fusion protein combining human tumor necrosis factor receptor II with an IgG1 Fc domain. Protalix investigated it for oral administration, a potentially distinctive approach in biologic-drug delivery. The company described the program as an effort to create an oral protein treatment in an area where conventional enzyme and protein medicines are generally administered by injection.
Investigational medical countermeasure
PRX-105
PRX-105 is a recombinant human acetylcholinesterase produced using a genetically modified tobacco-cell line. Protalix studied it as a potential countermeasure against exposure to nerve agents. The program completed exploratory Phase I clinical testing according to the supplied reference material.
Brand decisions
2012
Launch the first FDA-approved plant-cell pharmaceuticalProduct launchBackground
Protalix’s taliglucerase alfa program targeted type 1 Gaucher disease, for which patients require replacement of deficient glucocerebrosidase.
Action taken
Following FDA approval in May 2012, taliglucerase alfa was commercialized in the United States as Elelyso through the Pfizer collaboration.
Aftermath
The approval gave Protalix its first marketed medicine and established plant-cell expression as the company’s central commercial technology.
2009
Partner with Pfizer on taliglucerase alfaM&ABackground
Protalix needed a large pharmaceutical partner for the late-stage development, regulatory process, and international commercialization of its lead Gaucher-disease therapy.
Action taken
The company signed a collaboration agreement with Pfizer covering development and commercialization of taliglucerase alfa, with Brazil excluded from the licensed territory.
Aftermath
The partnership preceded FDA approval of Elelyso in 2012 and gave the product access to Pfizer’s commercial infrastructure in covered markets.
2006
Use a reverse merger to enter the public marketsM&ABackground
Protalix sought public-company status while developing a platform biotechnology business and entered into a transaction with over-the-counter-listed Orthodontix.
Action taken
The companies completed a reverse merger on December 31, 2006, after which Protalix pursued a broader exchange listing and conducted a public offering.
Aftermath
The transaction established Protalix as a public biotechnology company and supported later capital-market activity.
Recent events
Protalix reports first-quarter 2021 financial results[3]
Reported:
Protalix BioTherapeutics reported financial results for the first quarter ended March 31, 2021, including revenue of $4.5 million and a net loss of approximately $5.5 million.
Protalix announces Yael Hayon's appointment as VP of Research and Development[4]
Reported:
On June 8, 2020, Protalix announced Yael Hayon's appointment as Vice President, Research and Development, effective July 5, 2020.
Protalix announces R&D executive retirement[5]
Reported:
Protalix BioTherapeutics stated that Yoseph Shaaltiel retired from his Executive Vice President, Research and Development position on June 2, with the retirement effective June 15, 2020.
Protalix announces two board appointments[6]
Reported:
Protalix announced the appointment of Pol F. Boudes and Gwen A. Melincoff to its Board of Directors, effective January 1, 2020.
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