Corporate News Blog – Protalix BioTherapeutics Gets Positive Opinion for Orphan Designation of PRX-102 for Treatment of Fabry Disease in EU

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LONDON, UK / ACCESSWIRE / November 15, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Protalix BioTherapeutics, Inc. (NYSE: PLX), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=PLX. The Company announced on November 13, 2017, that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) issued a positive opinion on the Orphan Medicinal Product Application for PRX-102 (pegunigalsidase alfa) for the treatment of Fabry disease. Protalix BioTherapeutics works towards the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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About PRX- 102

Pegunigalsidase alfa is the Protalix’s PEGylated, chemically modified version of the recombinant alpha-Galactosidase-A protein. It has been specifically designed for the treatment of Fabry disease.

Currently, pegunigalsidase alfa is being evaluated globally in three phase-III clinical trials.

About Fabry Disease

Fabry disease is a rare genetic disease with a deficiency of an enzyme called alpha-Galactosidase A. This disease affects many parts of the body including the skin, eyes, gastrointestinal system, kidney, heart, brain, and nervous system.

Basis for COMP’s Positive Opinion

For the orphan medicinal product designation, Protalix had to provide medically plausible evidence that PRX-102 can offer meaningful benefit over the existing approved therapies in the European Union for the treatment of Fabry disease.

Protalix presented that although there are already certain satisfactory methods of treatment of Fabry disease approved in the European Union, PRX-102 can create meaningful value for those affected by the disease.

In its official opinion letter, COMP quoted clinical and non-clinical justifications given by Protalix to showcase the benefit of pegunigalsidase alfa.

COMP’s positive opinion is based on this information, which highlights the clinically relevant advantage of PRX-102.

Conditions for Orphan Medicinal Product Designation

For getting the designation of an Orphan Medicinal Product, the sponsor has to establish that no other satisfactory method of diagnosis, prevention, or treatment of the condition can be authorized in the European Union or, even if such a method exists, the medicinal product is of meaningful benefit to those affected by the condition.
Moreover, the sponsor needs to prove that the medicinal product in development is intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating. In fact, the prevalence of this condition must not be more than five in 10,000 persons.

Implications of the Orphan Designation

The Orphan Medicinal Product designation brings with it several preferential advantages. It qualifies the sponsor for 10 years of marketing exclusivity upon approval as well as certain fee reductions.

The Orphan product designation would provide the sponsor access to a centralized authorization procedure, including applications for marketing authorization and inspections, and for protocol assistance.

Last Close Stock Review

On Tuesday, November 14, 2017, the stock closed the trading session at $0.68, declining 5.40% from its previous closing price of $0.72. A total volume of 1.05 million shares have exchanged hands. Protalix BioTherapeutics’ stock price surged 13.52% in the last one month, 21.67% in the past three months, and 23.84% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have skyrocketed 53.06%. The stock currently has a market cap of $90.83 million.

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