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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
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 13, 2009
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Florida | 000-27836 | 65-0643773 | ||
| (State or other | (Commission | (IRS Employer | ||
| jurisdiction of | File Number) | Identification No.) | ||
| incorporation) |
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 20100
Science Park
POB 455
Carmiel, Israel 20100
(Address of principal executive offices) (Zip Code)
(Former Name or Former Address, if Changed Since Last Report)
Registrant’s telephone number, including area code: +972-4-988-9488
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)) |
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| Item 7.01. Regulation FD Disclosure | ||||||||
| Item 9.01. Financial Statements and Exhibits | ||||||||
| SIGNATURES | ||||||||
| EX-99.1: PRESS RELEASE | ||||||||
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Item 7.01. Regulation FD Disclosure
On February 13, 2009, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release
announcing that Dr. Einat Brill Almon, the Company’s Senior Vice President of Product Development,
will be presenting at the WORLD Symposium 2009, co-organized by Lysosomal Disease Network and the
National Institutes of Health. The symposium will take place February 18 through 20, 2009 at the
Westin Gaslamp Quarter in San Diego, California. Dr. Almon’s presentation, entitled “Novel Enzyme
Replacement Therapy for Gaucher Disease: On Going Phase III Clinical Trial with Recombinant Human
Glucocerebrosidase Expressed in Plant Cells,” will be delivered on Friday, February 20, 2009 at
9:10 AM PT.
Item 9.01. Financial Statements and Exhibits
| (d) | Exhibits |
| 99.1 | Press release dated February 13, 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: February 13, 2009
|
By: | /s/ David Aviezer
|
||||
| Name: | David Aviezer, Ph.D. | |||||
| Title: | President and | |||||
| Chief Executive Officer | ||||||
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Exhibit 99.1
Protalix BioTherapeutics to Present at the WORLD Lysosomal Disease Network Symposium 2009
CARMIEL, Israel, February 13, 2009 (Business Wire) — Protalix BioTherapeutics, Inc. (AMEX: PLX),
today announced that Dr. Einat Brill Almon, the Company’s Senior Vice President of Product
Development, will be presenting at the WORLD Symposium 2009, co-organized by Lysosomal Disease
Network and the National Institutes of Health. The symposium will take place February 18 through
20, 2009 at the Westin Gaslamp Quarter in San Diego, California. Dr. Almon’s presentation,
entitled “Novel Enzyme Replacement Therapy for Gaucher Disease: On-Going Phase III Clinical Trial
with Recombinant Human Glucocerebrosidase Expressed in Plant Cells,” will be delivered on Friday,
February 20, 2009 at 9:10 AM PT.
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. 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