UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): June 4, 2009
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Florida (State or other jurisdiction of incorporation) |
000-27836 (Commission File Number) |
65-0643773 (IRS Employer Identification No.) |
| 2 Snunit Street | ||
| Science Park, POB 455 | ||
| Carmiel, Israel | 20100 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code +972-4-988-9488
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7. Regulation FD
On June 4, 2009, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing
that Frost & Sullivan has presented the Company with Frost & Sullivan’s 2009 European Orphan
Diseases Market Product Innovation of the Year Award. A copy of the press release is attached
hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
| 99.1 | Press release dated June 4, 2009. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned hereunto duly authorized.
| PROTALIX BIOTHERAPEUTICS, INC. | ||||||
Date: June 4, 2009 |
||||||
| By: Name: |
/s/ David Aviezer
|
|||||
| Title: | President and | |||||
| Chief Executive Officer | ||||||
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Exhibit 99.1
Frost & Sullivan Presents Protalix Biotherapeutics with its 2009 European Orphan
Diseases Market Product Innovation of the Year Award
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
costs.
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.
Contact:
Marcy Nanus
The Trout Group, LLC
Telephone: 646-378-2927
Email: mnanus@troutgroup.com
Marcy Nanus
The Trout Group, LLC
Telephone: 646-378-2927
Email: mnanus@troutgroup.com