Full Press Release Details
Protalix BioTherapeutics Provides Full-Year
2014 Strategic Outlook
Dr. Aviezer to Present at the 32nd Annual J.P. Morgan Healthcare Conference
CARMIEL, Israel, January 13, 2014 /GlobeNewswire /Protalix BioTherapeutics,
Inc. (NYSE MKT:PLX, TASE:PLX), announced today that Dr. David Aviezer, the Company's President and Chief Executive Officer,
will discuss the Company's corporate objectives and key milestones in a presentation at the 32nd Annual J.P. Morgan Healthcare
Conference on Thursday, January 16, 2014 at 12:00 PM, Pacific Time. Dr. Aviezer's presentation will include a discussion
of the Company's 2014 strategic outlook and clinical highlights. A live webcast of the presentation will be available at
www.protalix.com on the event calendar page, and will be archived for 90 days.
"In 2014, Protalix anticipates achieving a number of milestones
on both the commercial and clinical front that have the potential to add significant value," commented Dr. Aviezer. "We
expect to see sales of ELELYSO (taliglucerase alfa) increase across all approved and launched territories, primarily in the
United States, Israel, Brazil, Chile and Mexico. Additionally, we expect ELELYSO to be approved in Canada, Australia and Argentina.
On the clinical front, we plan to report data from two key clinical programs, Oral GCD for the treatment of Gaucher disease and
PRX-102 for the treatment of Fabry disease, and to initiate clinical trials for our oral antiTNF and Dnase compounds."
ELELYSO/UPLYSO highlights
2014 Commercial and Clinical Milestones
ELELYSO/UPLYSO Milestones
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, by Israel's Ministry of Health in September
2012, by the Brazilian National Health Surveillance Agency (ANVISA) in March 2013, by the Mexican Federal Commission
for the Protection against Sanitary Risk (COFEPRIS) in April 2013 and by the regulatory authorities of other countries. Marketing
applications for taliglucerase alfa have been filed in additional territories as well. Protalix has partnered with Pfizer
Inc. for the worldwide development and commercialization of taliglucerase alfa, excluding Israel and 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; PRX-112, an orally-delivered glucocerebrosidase
enzyme that is produced and encapsulated within carrot cells, also for the treatment of Gaucher disease; pr-antiTNF, a similar
plant cell version of etanercept (Enbrel ) for the treatment of certain immune and inflammatory diseases, such as rheumatoid
arthritis, Crohn's disease, colitis, psoriasis and other autoimmune and inflammatory disorders; PRX-110 for the treatment
of Cystic Fibrosis; PRX-107 for the treatment of emphysema due to hereditary alpha1-antitrypsin deficiency; 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 "anticipate," "believe," "estimate," "expect,"
"project," "plan" and "intend" and other words or phrases of similar import are intended to identify
forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the progress
of our various clinical trials, potential future sales of our product and additional marketing approvals of our product. These
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 commercialization efforts for taliglucerase alfa in the United States, Israel, Brazil and other countries;
the risk of significant delays in the commercial introduction of taliglucerase alfa in other markets as planned; risks related
to the acceptance and use of taliglucerase alfa or any of our product candidates, if approved, by physicians, patients and third-party
payors; the risk that we will not be able to develop a successful sales and marketing organization for any of our product candidates
in a timely manner, if at all; failure or delay in the commencement or completion of our preclinical studies and clinical trials
which may be caused by several factors, including: unforeseen safety issues; determination of dosing issues; lack of effectiveness
during clinical trials; slower than expected rates of patient recruitment; inability to monitor patients adequately during or after
treatment; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols;
lack of sufficient funding to finance our clinical trials; the risk that the results of our clinical trials will not support the
applicable claims of safety or efficacy, that our product candidates will not have the desired effects or includes undesirable
side effects or other unexpected characteristics; our dependence on performance by third party providers of services and supplies,
including without limitation, clinical trial services; delays in the approval or the potential rejection of any application filed
with or submitted to the regulatory authorities reviewing taliglucerase alfa outside of the United States, Israel, Brazil and other
countries in which taliglucerase alfa is already approved; our ability to establish and maintain strategic license, collaboration
and distribution arrangements, and to manage our relationships with Pfizer Inc., Fiocruz or any other collaborator, distributor
or partner; delays in our preparation and filing of applications for regulatory approval of our other product candidates in the
United States, the European Union and elsewhere; our expectations with respect to the potential commercial value of our product
and product candidates; the risk that products that are competitive to our product candidates may be granted orphan drug status
in certain territories and, therefore, our product candidates may be subject to potential marketing and commercialization restrictions;
the impact of the development of competing therapies and/or technologies; any lack of progress of our research and development
activities and our clinical activities with respect to any product candidate; risks relating to our ability to make scheduled payments
of the principal of, to pay interest on or to refinance our 2018 convertible notes, or any other indebtedness; potential product
liability risks; risks related to the potential infringement of a third party's patents or other intellectual property rights;
the uncertainty of obtaining patents covering our products and processes and in successfully enforcing our intellectual property
rights against third parties; risks of securing adequate levels of product liability and clinical trial insurance coverage; and
other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this release are valid
only as of the date hereof and we disclaim any obligation to update this information.
The Trout Group, LLC
MacDougall Biomedical Communications
Source: Protalix BioTherapeutics, Inc.