Full Press Release Details
Protalix BioTherapeutics Provides Review
and Strategic Outlook for 2017
Full Switch Plan Initiated and Published
by Brazilian Ministry of Health for Gaucher Patients in Brazil Yielding Significant Revenue Stream
Fabry Phase III Clinical Trial Underway
with Interim Results Expected in 2018
Phase II Clinical Trial for Cystic
Fibrosis Positive Interim Data Reported
with Full Results Expected During First Quarter of 2017
Phase II Clinical Trial of Oral anti
TNF for Ulcerative Colitis Initiated
with Results Expected in Second Half of 2017
New Pipeline Candidates for Indications
for which there are Currently No Approved Drugs or that address Significant Unmet Medical Needs anticipated to be announced publicly
and to progress into Clinical Development
CARMIEL, Israel, January 9, 2017 - Protalix BioTherapeutics,
Inc. (NYSE MKT:PLX) (TASE:PLX) today announced a review of the Company's clinical and financial highlights for 2016, as well
as an outlook for anticipated future strategic milestones.
"2016 was a building year for Protalix. We aggressively
pushed our clinical pipeline programs forward, which included high level regulatory agency discussions and the initiation of clinical
trials for all three of our disclosed leading assets," said Moshe Manor, Protalix's President and Chief Executive Officer.
"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."
2016 and Recent Clinical Highlights
2017 Outlook and Projected Future Milestones
A copy of the Company's January 2017 Corporate Update
will be posted in the Presentations page of the Investors tab of its corporate website.
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 . 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: pegunigalsidase alfa, 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; alidornase alfa 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,"
"project," "plan," "should" 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 Funda o
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 Funda o 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 revenues, operations and expenditures; 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; our ability to identify
suitable product candidates and to complete preclinical studies of such product candidates; 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.
The Trout Group, LLC
Source: Protalix BioTherapeutics, Inc.