Yahoo Finance Protalix (PLX) Fabry Disease Candidate Gets Orphan Status
Protalix BioTherapeutics, Inc. PLX announced that the European Commission (“EC”) has granted orphan drug designation to its pipeline candidate, PRX-102 (pegunigalsidase alfa). The small biotech company is developing PRX-102 for patients with Fabry disease, a rare inherited genetic lysosomal disorder.
The orphan status for PRX-102 was expected as the Committee for Orphan Medicinal Products in Europe had recommended the grant on Nov 13, 2017.
Shares of the company rose almost 2.26% on Dec 27, including after-hours movement. In fact, Protalix’s shares are up 48.3% so far this year, outperforming the industry’s gain of 3.5% in that period.
The intravenous administration of the candidate is currently being evaluated in a phase III study in patients who have received Shire plc’s SHPG Replagal. Data from the study is expected in the second half of 2018.
Another phase III study is evaluating PRX-102 in patients with Fabry disease patients who have impaired renal function and have been treated with Sanofi’s SNY Fabrazyme. Another phase III study is evaluating the candidate in moderate-to-severe gastrointestinal symptoms in treatment naïve Fabry disease patients.
Both Replagal and Fabrazyme are approved for treating Fabry disease. While Replagal recorded sales of $349 million in the first nine months of 2017, Fabrazyme generated sales of more than $600 million in that period. This represent a significant prospect for PRX-102 upon potential approval.
The orphan drug status, if valid till approval, will give PRX-102 an exclusivity for 10 years.
Protalix has one marketed drug, Elelyso, which is approved for treating Gaucher disease. It has generated sales of $16.8 million in the first nine months of 2017. The drug is marketed by Pfizer Inc. PFE in the United States as part of an exclusive license and supply agreement.
The company is also developing PRX-110 for treating cystic fibrosis and OPRX-106 as an orally-delivered anti-inflammatory treatment.
Protalix BioTherapeutics, Inc. Price
Protalix BioTherapeutics, Inc. Price | Protalix BioTherapeutics, Inc. Quote
Protalix currently has a Zacks Rank #4 (Sell).
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