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Protalix BioTherapeutics Names Tzvi Palash Chief Operating Officer

Key Takeaway: Protalix BioTherapeutics Names Tzvi Palash Chief Operating Officer CARMIEL, Israel, September 7, 2010 Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX) today announced the appointment of Mr. Tzvi Palash as the Company s Chief Operating Officer. In this newly created position, Mr

Full Press Release Details

Protalix BioTherapeutics Names Tzvi Palash Chief Operating Officer
CARMIEL, Israel, September 7, 2010 Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX) today
announced the appointment of Mr. Tzvi Palash as the Company s Chief Operating Officer. In this
newly created position, Mr. Palash will be responsible for overseeing the Company s manufacturing
activities and implementing the expansion phase of the Company s facility as it transitions from a
research and development organization to a fully-integrated biotechnology company.
Mr. Palash brings over 25 years of expertise in commercial operations in the healthcare industry to
the Company, including experience in the planning, construction and scale-up of manufacturing
facilities, product quality assurance (QA) and validation, regulatory compliance and general
production oversight for biotechnology and pharmaceutical companies. Prior to joining the Company,
he served as General Manager at ColBar LifeScience Ltd., a subsidiary of Johnson Johnson, Plant
Manager at C.T.S., (a drug manufacturing facility), QA manager at Teva Pharmaceutical Industries
and Production Manager at Interpharm Laboratories, a subsidiary of Serono.
Protalix is at an exciting stage in its evolution as it prepares for the anticipated launch of
taliglucerase alfa for the treatment of Gaucher disease and advances its drug pipeline through
clinical development. It is crucial that we continue to maintain the quality and supply of our
product candidates as we embark on commercialization and continue to grow. We are delighted to
have Tzvi join us, given his experience in manufacturing and commercial operations, said Dr. David
Aviezer, the Company s President and Chief Executive Officer. His knowledge and experience in
product operations, particularly in biologics manufacturing, scale-up and quality assurance, is an
important asset for Protalix.
As General Manager at ColBar LifeScience, he was responsible for overseeing all operations,
including product development and manufacturing for the Company s Collagen based Glymatrix
technology. He successfully led FDA audits for Evolence and Ossix , and was
a member of the Global Aesthetic Management Team within the Consumer Group of Johnson Johnson.
At ColBar LifeScience, Mr. Palash led the planning, construction, scale-up and regulatory oversight
of their manufacturing facility. Prior to joining ColBar LifeScience in 2001, Mr. Palash has,
amongst other roles, led the planning and construction of a pharmaceutical manufacturing facility
for C.T.S. and was involved in the construction and scale up of a recombinant interferon plant for
Interpharm Laboratories, where he was Production Manager for human fibroblast interferon
Mr. Palash received a B.Sc. in Biology from the Tel Aviv University and a M.Sc. in Biochemistry
from the Hebrew University, Jerusalem.
Protalix is a biopharmaceutical company focused on the development and commercialization of
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. The Company s new drug application (NDA) for taliglucerase alfa has been accepted by the
U.S. Food and Drug Administration (FDA) and granted a Prescription Drug User Fee Act (PDUFA) action
date of February 25, 2011.
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 our 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 for taliglucerase alfa and including the risk that
regulatory authorities may find that the data from our clinical trials and other studies is
insufficient for regulatory approval; 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, including
the NDA we filed with the FDA for taliglucerase alfa for the treatment of Gaucher disease; 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; 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 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
Telephone: 646-378-2927
Last updated: Sep 7, 2010