Full Press Release Details
Frost Sullivan Presents Protalix Biotherapeutics with its 2009 European Orphan
Diseases Market Product Innovation of the Year Award
CARMIEL, Israel, June 4, 2009 (Business Wire) Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX),
announced today that Frost Sullivan has presented the Company with its 2009 European Orphan
Diseases Market Product Innovation of the Year Award. In presenting the award, Frost Sullivan
noted the Company s impressive display of technology and innovative efforts in developing prGCD,
the Company s proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD)
for the treatment of Gaucher disease using its proprietary expression system, ProCellEx .
Frost Sullivan bestows the European Orphan Diseases Market Product Innovation Award on a company
or individual that has performed new research which has resulted in technological innovation(s)
that have brought, or are expected to bring, significant contributions to the industry in terms of
adoption, change, and competitive posture. The award recognizes the quality and depth of the
recipient s research and development program as well as the vision and risk-taking that enabled the
recipient to undertake the research for which the recipient is being recognized.
In granting this award to Protalix, Frost Sullivan noted that ProCellEx, the Company s
proprietary expression system used to produce prGCD, has the potential to enhance drug properties
such as better efficacy, longer half-life, cost effectiveness and better patient compliance.
According to Frost Sullivan, the Company s product candidates are expected to be cost effective
when compared to existing therapies because they are produced using, a plant cell culture-based
expression system. Existing enzyme replacement therapies are produced using mammalian cell-based
expression systems, a production method that is expensive and results in increased production
Frost Sullivan further stated that through the development of prGCD using the ProCellEx
production system, Protalix Biotherapeutics has developed a product with capabilities and
characteristics that positively differentiate it from the enzyme replacement therapies available in
the market. The current global market of Gaucher disease is estimated around $1.30 billion and
there is only one enzyme replacement therapy currently available. By positioning its focus on a
high profile and underserved area of orphan diseases, Protalix Biotherapeutics has moved to become
a recognized name for product innovation in the area.
Receiving this award from Frost Sullivan provides further validation of our innovative approach
to manufacturing proteins in a plant cell-based expression system, said Dr. David Aviezer, the
Company s President and Chief Executive Officer. We have completed patient enrollment in our
pivotal Phase III clinical trial of prGCD for the treatment of Gaucher disease, and the trial s
design was the product of an agreement with the FDA under its special protocol assessment process.
We look forward to reporting the results of this trial in the fourth quarter of 2009.
About Frost and Sullivan
Frost Sullivan, the Growth Consulting Company, partners with clients to accelerate their growth.
The company s Growth Partnership Services, Growth Consulting and Career Best Practices empower
clients to create a growth focused culture that generates, evaluates and
implements effective growth strategies. Frost Sullivan employs over 45 years of experience in
partnering with Global 1000 companies, emerging businesses and the investment community from more
than 30 offices on six continents. For more information about Frost Sullivan s Growth
Partnerships, visit http://www.frost.com.
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(TM) 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. The study is monitored by an independent Data Monitoring
Committee including experts in the field, who monitor the on going safety data, which has recently
held their last scheduled meeting before the end of the trial. No serious adverse events have been
reported in the study. Protalix is also advancing additional recombinant biopharmaceutical drug
development programs.
The Trout Group, LLC
Telephone: 646-378-2927
Email: mnanus@troutgroup.com