Full Press Release Details
Protalix Announces New
Clinical Data on Taliglucerase Alfa to be Presented at the WORLD Lysosomal Disease Network Symposium
CARMIEL, Israel, January
26, 2012 /GlobeNewswire/Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX, TASE:PLX), announced today that new clinical data on taliglucerase
alfa will be presented at the 8th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2012 being held February 8-10
in San Diego, California.
Professor Ari Zimran, M.D.,
Director of the Gaucher Clinic, Shaare Zedek Medical Center, Jerusalem, Israel, will deliver an oral presentation entitled "Long
term safety and efficacy data of taliglucerase alfa, a Plant Cell Expressed Recombinant Glucocerebrosidase, in treatment of Na ve
Gaucher Disease patients" which has been scheduled for Friday, February 10, 2012 at 3:45 PM PT.
Gregory Pastores, M.D., Professor
of Neurology and Pediatrics and Director of the Neurogenetics Laboratory at New York University School of Medicine, will deliver
an oral presentation entitled "Plant Cell Expressed Recombinant Glucocerebrosidase taliglucerase alfa as Therapy for Gaucher
Disease in Patients Previously Treated with Imiglucerase" which has been scheduled for Friday, February 10, 2012 at
Laura van Dussen, M.D., of
the Academic Medical Center, University of Amsterdam, will introduce a poster entitled "Long term bone marrow responses,
as measured by Quantitative Chemical Shift Imaging (QCSI) MRI, following treatment with taliglucerase alfa in patients with type
1 Gaucher Disease." The poster will be presented on Wednesday, February 8, 2012 from 5:00-7:00 PM PT and Thursday, February
9, 2012 from 4:00-6:00 PM PT.
About the Lysosomal Disease
The goal of the Lysosomal
Disease Network is to provide an interdisciplinary forum to explore and discuss specific areas of interest, research and clinical
applicability related to lysosomal diseases. The WORLD symposium is designed to help researchers and clinicians better manage and
understand diagnostic options for patients with storage diseases; identify areas requiring additional basic and clinical research,
public policy and regulatory attention; and identify the latest findings in the natural history of lysosomal diseases. For additional
information on the symposium, please go to www.lysosomaldiseasenetwork.org.
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 in an environment free of mammalian components and viruses. Protalix's
lead compound, taliglucerase alfa, an enzyme replacement therapy for the treatment of Gaucher disease, completed phase III development.
To date, marketing applications have been submitted for taliglucerase alfa in the United States, the European Union, Brazil, Israel
and Australia. Protalix's development pipeline also 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-105, a pegylated recombinant human acetylcholinesterase
in development for several therapeutic and prophylactic indications, a biodefense program and an organophosphate-based pesticide
treatment program; an orally-delivered glucocerebrosidase enzyme that is naturally encased in carrot cells, also for the treatment
of Gaucher disease; pr-antiTNF, a similar plant cell version of etanercept (Enbrel(R)) for the treatment of certain immune diseases
such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis;
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" 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 relating to the review process of the FDA, the European Medicines Agency (EMA), other foreign regulatory
bodies and other governmental regulatory bodies, including the risk that regulatory authorities may find that the data from our
clinical trials and other studies is insufficient for regulatory approval; risks relating to delays in the FDA's, the EMA's or
other foreign regulatory authorities' approval of any applications we file or refusals to approve such filings, including the NDA
we filed with the FDA for taliglucerase alfa for the treatment of Gaucher disease; the risk that applicable regulatory authorities
may refuse to approve the marketing and sale of a drug product even after acceptance of an application we file for the drug product;
risks relating to the completion of our clinical trials; and other factors described in our filings with the Securities and Exchange
Commission. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced or late-stage
clinical trials, even after obtaining promising earlier trial results or in preliminary findings for such clinical trials. Further,
even if favorable testing data is generated from clinical trials of drug products, the FDA, EMA or any other foreign regulatory
authority may not accept or approve an NDA filed by a pharmaceutical or biotechnology company for such drug product. Failure to
obtain approval from the FDA, EMA or any other foreign regulatory authority of any of our drug candidates in a timely manner, if
at all, will severely undermine our business and results of operations by reducing our potential marketable products and our ability
to generate corresponding product revenues. 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
Jennifer Conrad or Kari Watson
MacDougall Biomedical Communications