Israeli drug development company Protalix Biotherapeutics Inc. (NYSE:PLX; TASE: PLX) announced yesterday that it had received a $24 million order from the Brazilian Ministry of Health for its Gaucher disease treatmernt alfataliglicerase. The first shipment will be made in the middle of 2017, and the last at the end of 2017. The company's share price rose 11.67% on the NYSE last night, giving a market cap of $41 million.
Protalix president and CEO Moshe Manor said, "To date, we have sold relatively small quantities of alfataliglicerase to the Brazilian Ministry of Health, which has allowed physicians and patients in Brazil to experience firsthand the drug’s beneficial efficacy and safety profile."
He added, "The Brazilian Ministry’s request to purchase considerably larger quantities comes on the heels of advanced negotiations with the ministry regarding the potential of alfataliglicerase becoming the preferred enzyme replacement therapy for the approximately 700 Gaucher patients treated in Brazil. The anticipated revenues could reduce our cash consumption rate by as much as a third in 2017; if we were to continue to experience increased demand from the Brazilian Ministry to the extent indicated in the letter, the anticipated revenues would have the potential to reach a breakeven point."
Gaucher disease is a rare lysosomal storage disorder. Alfataliglicerase is a plant cell-expressed form of the glucocerebrosidase enzyme that was approved by the Brazilian National Health Surveillance Agency in March 2013 for the long-term treatment of adults with Type I Gaucher disease and in November 2016 for the long-term treatment of children four years of age and above with Type I Gaucher disease. Protalix owns all rights to alfataliglicerase in Brazil.
The Karmiel based company focuses on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx(R). Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner.
Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the US Food and Drug Administration (FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.
Protalix’s development pipeline includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; PRX-110 for the treatment of Cystic Fibrosis; and others.
Protalix recently agreed a debt settlement, which leaves it with a debt of $14 million to be paid in 2018 while the remainder of the debt may be converted to shares before 2021. An injection of $24 million cash from the Brazilian government could help the company balance its books while further orders could also bring it to profitability. The company has $72 million in cash available for financing further clinical trials for new products.
Published by Globes [online], Israel business news - www.globes-online.com - on December 15, 2016
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