Full Press Release Details
Protalix BioTherapeutics Receives Research Grant of over $6 million from the Israeli Government s
Office of the Chief Scientist
CARMIEL, Israel, March 11, 2009 (Business Wire) Protalix BioTherapeutics, Inc. (NYSE Alternext
US:PLX), announced today that the Office of the Chief Scientist ( OCS ) of Israel s Ministry of
Industry, Trade and Labor has awarded a grant of over $6 million to the Company for calendar year
2009. The OCS awarded the grant to the Company to promote the advancement of the Company s clinical
and preclinical drug development programs.
The terms of the grant provide that a significant amount of the funds awarded are to be used in
connection with the development of the Company s phase III clinical trial of prGCD, the Company s
plant cell expressed recombinant Glucocerebrosidase enzyme for the treatment of Gaucher disease.
prGCD is currently the subject of a phase III clinical trial under the Special Protocol Assessment
(SPA) process of the United States Food and Drug Administration in which prGCD is being studied as
an enzyme replacement therapy for Gaucher disease. Enrollment for the phase III clinical trial was
completed in December 2008, and the Company expects to report top-line results of the trial in the
second half of 2009. The Company plans to submit a New Drug Application (NDA) for prGCD to the FDA,
the Israeli Ministry of Health and other comparable regulatory agencies in other countries in the
fourth quarter of 2009. In addition to the funds allocated to the development of prGCD, the grant
includes a smaller amount of funds for the advancement of two of the other drug candidates in the
Company s pipeline, acetylcholinesterase (AChE) and PRX-102. Funds from the grant are to be applied
to the Company s preclinical development and, if the preclinical development is successful, to a
phase I clinical trial of a plant cell-based acetylcholinesterase (AChE) for several therapeutic
indications, including a biodefense program for anti-organophosphate nerve agent treatment. Funds
are also to be applied to the Company s preclinical development PRX-102, a therapeutic enzyme for
the treatment of Fabry disease. The grant is available through the end of 2009 and funds are to be
made available to the Company over the course of the year based on actual expenditures made by the
Company in connection with the designated programs.
As we make strides to transform Protalix from a clinical development Company to a commercial
organization, we appreciate the continued support of the OCS, said Dr. David Aviezer, President
and Chief Executive Officer of the Company. We believe that this grant represents a vote of
confidence for our product candidates and technology, and strengthens our relationship with the
Government of Israel.
About the Application to the Office of the Chief Scientist
Grants from the OCS are judged on various criteria including innovation and uniqueness of the
technology or product, potential market forecasts, and capabilities of the company in areas
including financial strength, R D capabilities, and management experience.
The Chief Scientist is largely focused on promoting the growth of commercial research and
development in Israel. Its implementation of a 1984 government policy, codified in the Law for the
Encouragement of Industrial Research and Development, includes various assistance programs that
provide qualifying companies in high-tech industries with incentives to avidly undertake R D
activities. By sharing the risks inherent in high-tech research and development projects, the
Israeli government hopes to facilitate expansion of its growing technological infrastructure, a
main component of the country s economy. The Company is required to repay to the OCS up to 100% of
grants actually received through payments of royalties at a rate of 3% to 6% of the revenues
generated from an OCS-funded project, depending on the period in which revenues were generated.
About Protalix BioTherapeutics
Protalix is a biopharmaceutical company. Its goal is to become a fully integrated biopharmaceutical
company focused on the development and commercialization of proprietary recombinant therapeutic
proteins to be 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. Protalix is conducting a phase III pivotal study for its lead product
candidate, prGCD, to be used in enzyme replacement therapy for Gaucher disease, a lysosomal storage
disorder in humans. Protalix has reached an agreement with the United States Food and Drug
Administration on the final design of the pivotal phase III clinical trial through the FDA s
Special Protocol Assessment (SPA) process. Protalix has completed enrollment for this study and is
treating patients in its pivotal phase III clinical trial in North America, South America, Israel,
Europe and South Africa. Protalix is also advancing additional recombinant biopharmaceutical drug
development programs.
The Trout Group, LLC
Telephone: 646-378-2927
Email: mnanus@troutgroup.com