CARMIEL, Israel, Dec. 14, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) (the
“Company”) announced today that the Company received a letter from Fundação Oswaldo Cruz (Fiocruz), an arm of the Brazilian
Ministry of Health (the “Brazilian Ministry”), detailing intended purchases by the Brazilian Ministry of alfataliglicerase to treat
Gaucher patients in Brazil. The letter requests three shipments of alfataliglicerase; the first shipment to be made in the
middle of 2017, and the last at the end of 2017. The Company estimates total revenues from these shipments to be
approximately $24 million in aggregate.
“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,” said Mr. Moshe Manor,
Protalix’s President and Chief Executive Officer. “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.
The Company owns all rights to alfataliglicerase in Brazil.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused 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 U.S. 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.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and
are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms “expect,”
“anticipate, “believe,” “estimate,” “plan” and “intend” and other words or phrases of similar import are intended to identify
forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that
may cause actual future experience and results to differ materially from the statements made. These statements are based on
our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of
risk. Factors that might cause material differences include, among others: risks related to the ultimate purchase by Fundação
Oswaldo Cruz of alfataliglicerase pursuant to the stated purchase intentions of the Brazilian Ministry of Health of the stated
amounts, if at all; risks related to the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding
the purchase of alfataliglicerase generally; risks related to our commercialization efforts for alfataliglicerase in Brazil; risks
relating to the compliance by Fundação Oswaldo Cruz with its purchase obligations and related milestones under our supply and
technology transfer agreement; risks related to the amount and sufficiency of our cash and cash equivalents; risks related to the
amount of our future operating expenses; failure or delay in the commencement or completion of our preclinical and clinical trials
which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues;
determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or
after treatment; inability or unwillingness of medical investigators and institutional review boards to follow our clinical
protocols; and lack of sufficient funding to finance clinical trials; the risk that the results of the clinical trials of our
product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects
or will be associated with undesirable side effects or other unexpected characteristics; risks relating to our ability to make
scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; our
dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services;
delays in our preparation and filing of applications for regulatory approval; delays in the approval or potential rejection of any
applications we file with the FDA or other health regulatory authorities, and other risks relating to the review process; the
inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development
of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of
securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings
with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof
and we disclaim any obligation to update this information, except as may be required by law.
Investor Contact Marcy Nanus The Trout Group, LLC 646-378-2927 mnanus@troutgroup.com
