Protalix BioTherapeutics (PLX) is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx® protein expression system, or ProCellEx. The company developed its first commercial drug product, ElelysoTM, using its ProCellEx system and The company is now focused on utilizing the system to develop a pipeline of proprietary, clinically superior versions of recombinant therapeutic proteins that primarily target large, established pharmaceutical markets and that in most cases rely upon known biological mechanisms of action. With its experience to date, The company believe ProCellEx will enable it to develop additional proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications. The company is now also applying the unique properties of its ProCellEx system for the oral delivery of therapeutic proteins.1

On May 1, 2012, the FDA approved for sale of The company's first commercial product, taliglucerase alfa for injection, an enzyme replacement therapy, or ERT, for the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease. Subsequently, taliglucerase alfa was approved for marketing by the regulatory authorities of other countries. Taliglucerase alfa is called alfataliglicerase in Brazil and certain other Latin American countries, where it is marketed under the name UplysoTM. Taliglucerase alfa is marketed under the name Elelyso in other territories.

Since its approval by the FDA, taliglucerase alfa has been marketed mainly in the United States by Pfizer, as provided in the exclusive license and supply agreement by and between Protalix Ltd., its wholly-owned subsidiary, and Pfizer, which The company refer to as the Pfizer Agreement. In October 2015, The company entered into an Amended and Restated Exclusive License and Supply Agreement, or the Amended Pfizer Agreement, which amends and restates the Pfizer Agreement in its entirety. Pursuant to the Amended Pfizer Agreement, The company sold to Pfizer its share in the collaboration created under the initial Pfizer Agreement for the commercialization of Elelyso in exchange for a cash payment equal to $36.0 million. As part of the sale, The company agreed to transfer its rights to Elelyso in Israel to Pfizer, while gaining full rights to Elelyso in Brazil. The company will continue to manufacture drug substance for Pfizer, subject to certain terms and conditions. Under the initial Pfizer Agreement, Pfizer shared revenues and expenses for the development and commercialization of Elelyso with it on a 60%/40% basis globally, excluding Israel and Brazil. Under the Amended Pfizer Agreement, Pfizer is responsible for 100% of expenses, and entitled to all revenues globally for Elelyso, excluding Brazil, where The company is responsible for all expenses and retain all revenues.

For the first 10-year period after the execution of the Amended Pfizer Agreement, The company have agreed to sell drug substance to Pfizer for the production of Elelyso, and Pfizer maintains the right to extend the supply period for up to two additional 30-month periods subject to certain terms and conditions. Any failure to comply with its supply commitments may subject it to substantial financial penalties, which will have a material adverse effect on its business, results of operations and financial condition. The Amended Pfizer Agreement also includes customary provisions regarding cooperation for regulatory matters, patent enforcement, termination, indemnification and insurance requirements.

On June 18, 2013, Protalix BioTherapeutics entered into a Supply and Technology Transfer Agreement, or the Brazil Agreement, with Fiocruz, an arm of the Brazilian MoH, for taliglucerase alfa.

In December 2016, Protalix BioTherapeutics received a letter from Fiocruz regarding an order from the Brazilian MoH to purchase alfataliglicerase to treat Gaucher patients in Brazil. The Brazilian MoH’s order consists of a number of shipments during 2017 for a total of approximately $24.3 million. Shipments started in June 2017 and are expected to continue through the end of the year, in increasing volumes. Fiocruz’s purchases of Uplyso to date have been significantly below certain agreed upon purchase milestones and, accordingly, The company has the right to terminate the Brazil Agreement. Notwithstanding the low purchase amounts, The company is, at this time, continuing to supply Uplyso to Fiocruz under the Brazil Agreement, and patients continue to be treated with Uplyso in Brazil. The company are discussing with Fiocruz potential actions that Fiocruz may take to comply with its purchase obligations and, based on such discussions, The company will determine what The company believe to be the course of action that is in the best interest of its company.

Protalix BioTherapeutics is developing an innovative product pipeline using its ProCellEx protein expression system. The company product pipeline currently includes, among other candidates:

(1) PRX-102, or alpha-GAL-A, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder in humans, currently in an ongoing phase III clinical trial.

(2) PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or alidornase alfa, under development for the treatment of cystic fibrosis, to be administered by inhalation. alidornase alfa has successfully completed a phase II efficacy and safety study.

(3) OPRX-106, its oral antiTNF product candidate which is being developed as an orally-delivered anti-inflammatory treatment using plant cells as a natural capsule for the expressed protein. Patient enrollment in its phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis was initiated in the fourth quarter of 2016.

Except for the rights to commercialize taliglucerase alfa worldwide (other than Brazil), which the company licensed to Pfizer, The company hold the worldwide commercialization rights to all of its proprietary development candidates. In addition, the company continuously evaluate potential strategic marketing partnerships as well as collaboration programs with biotechnology and pharmaceutical companies and academic research institutes.

References

  1. ^ https://fintel.io/doc/sec-plx-protalix-biotherapeutics-10k-annual-report-2018-march-06-18004
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Created by Asif Farooqui on 2019/12/16 16:04
     
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