JERUSALEM (dpa-AFX) - Protalix BioTherapeutics Inc. (PLX) announced a review of the company's clinical and financial highlights for 2016, as well as an outlook for anticipated future strategic milestones.
'Given our recent financing and the projected revenue stream from sales of alfataliglicerase in Brazil, we are well capitalized to deliver on our anticipated, value building milestones. Over the course of 2017 and into 2018, we expect to announce data from our phase III clinical trial on Fabry disease, final results from our phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis and results from our phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis. We expect that 2017 will be an extremely important, inflection year for us, with a number of significant commercial and clinical milestones that should bring considerable value to our stockholders,' said Moshe Manor, Protalix's President and Chief Executive Officer.
Full results for the phase II efficacy and safety study of alidornase alfa are expected to be announced during the first quarter of 2017.
Full results for the phase II efficacy and safety study of OPRX-106 are expected to be announced during the second half of 2017.
Completion of enrollment in the phase III trial of pegunigalsidase alfa for the treatment of Fabry disease expected in 2017; interim data analysis anticipated in 2018 to support EMA and other regulatory filings outside of the United States.
If superiority to Fabrazyme is not yet achieved at that time the trial will continue for an additional year before reporting two-year data to support a U.S. regulatory filing.
Received purchase order from the Brazilian Ministry of Health for purchase of alfataliglicerase to treat Gaucher patients in Brazil. The order consists of a number of shipments during 2017, in increasing volumes, for a total of approximately $24.3 million. The size of the final shipment of the order represents annual revenues of approximately $42.0 million. The Brazilian Ministry of Health's order was published in the December publication of Brazil's Official Diary of the Union (Diário Oficial).
Reported positive interim results from the Company's phase II clinical trial of alidornase alfa (PRX-110) for the treatment of Cystic Fibrosis, which results include a clinically meaningful increase in percent predicted forced expiratory volume in one second (ppFEV1).
Initiated patient enrollment in the Company's phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis. The Company is developing OPRX-106 to be the first ever oral protein treatment, as currently there are no other oral protein treatments available.
Copyright RTT News/dpa-AFX