Full Press Release Details
Protalix Announces Presentation of Phase III taliglucerase alfa Data at WORLD Lysosomal Disease
CARMIEL, Israel, February 4, 2010 Protalix Biotherapeutics, Inc. (NYSE- Amex: PLX) today
announced that data from its pivotal Phase III trial of taliglucerase alfa in patients with Gaucher
disease will be presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium
2010, February 10-12, 2010 in Miami, Florida.
Hanna Rosenbaum, M.D., Director of Hematology Day Care Unit, RAMBAM Medical Center, Haifa, Israel
and study investigator, will give the oral presentation, titled: Novel Enzyme Replacement Therapy
for Gaucher Disease: Phase III Pivotal Clinical Trial with Plant Cell Expressed Recombinant
Glucocerebrosidase (prGCD) taliglucerase alfa, on Thursday, February 11, 2010 at 10:15 AM ET.
The symposium is co-organized by the Lysosomal Disease Network and the National Institutes of
Health. Participants include clinicians, geneticists, neurologists and other health care
About Gaucher disease
Gaucher disease, an inherited condition, is the most prevalent lysosomal storage disorder, with an
incidence of about 1 in 20,000 live births. People with Gaucher disease do not have enough of an
enzyme, beta-glucosidase (glucocerebrosidase) that breaks down a certain type of fat molecule. As
a result, lipid engorged cells (called Gaucher cells) amass in different parts of the body,
primarily the spleen, liver and bone marrow. Accumulation of Gaucher cells may cause spleen and
liver enlargement, anemia, excessive bleeding and bruising, bone disease and a number of other
Protalix is a biopharmaceutical company focused on the development and commercialization of
proprietary recombinant therapeutic proteins expressed through its proprietary plant cell based
expression system. Protalix s ProCellEx presents a proprietary method for the expression of
recombinant proteins that Protalix believes will allow for the cost-effective, industrial-scale
production of recombinant therapeutic proteins in an environment free of mammalian components and
viruses. Protalix is also advancing additional recombinant biopharmaceutical drug development
programs. Taliglucerase alfa is an enzyme replacement therapy in development under a Special
Protocol Assessment with the FDA for Gaucher disease.
Safe Harbor Statement:
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. 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
successful preclinical development of our product candidates; the completion of clinical trials;
the review process of the FDA, the EMEA, other foreign regulatory bodies and other governmental
regulatory bodies, including the FDA s and the EMEA s review of any filings we make in connection
with the treatment protocol; delays in the FDA s, the EMEA s or other health regulatory
authorities approval of any applications we file or refusals to approve such filings; refusals by
such regulatory authorities to approve the marketing and sale of a drug product even after
acceptance of an application we file for any such drug product; the identification of lead
compounds; the risk that we may fail to satisfy certain conditions relating to grants we have
received from the Office of the Chief Scientist of Israel s Ministry of Industry and Trade which
may lead to our being required to refund grants previously received together with interest and
penalties; the risk that the Office of the Chief Scientist may not deliver to us all of the funds
awarded to us; uncertainties related to the ability to attract and retain partners for our
technologies and products under development; 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 by clinical trials of drug products, the FDA, EMEA 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, EMEA 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 operation 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
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