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): September 17, 2008
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Florida | 000-27836 | 65-0643773 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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))
Item 7.01. Regulation FD Disclosure
On September 17, 2008, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release
announcing that Dr. David Aviezer, the Company’s President and Chief Executive Officer, will
present at the UBS Global Life Sciences Conference on Wednesday, September 24, 2008 at 1:30 PM, ET.
The conference is being held at the Grand Hyatt Hotel in New York City. A copy of the press
release is furnished as Exhibit 99.1.
An audio
webcast of the corporate presentation will be available on the
Company’s website at www.protalix.com under the events calendar
section.
The information in Item 7.01 of this report (including Exhibit 99.1) is being furnished pursuant to
Item 7.01 of Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of
that section, nor shall it be deemed to be incorporated by reference in any filing under the
Securities Act of 1933 or the Exchange Act.
Item 8.01. Other Events
On September 22, 2008, the Company issued a press release announcing that it has enrolled more than
75% of the patients required for the Company’s on-going phase III clinical trial of its lead
product candidate, prGCD, a proprietary plant cell expressed recombinant form of human
Glucocerebrosidase (GCD) for the treatment of Gaucher disease, and that the Company anticipates
completion of enrollment in the clinical trial during the second half of 2008. A copy of the press
release is attached hereto as Exhibit 99.2.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
| 99.1 | Press release dated September 17, 2008. | |
| 99.2 | Press release dated September 22, 2008. |
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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: September 22, 2008 | 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 UBS Global Life Sciences Conference
CARMIEL, Israel, September 17, 2008 (Business Wire) — Protalix BioTherapeutics, Inc. (Amex: PLX),
announced today that Dr. David Aviezer, President and CEO, will present at the UBS Global Life
Sciences Conference on Wednesday, September 24, 2008 at 1:30 PM ET. The conference is being held at
the Grand Hyatt Hotel in New York City.
An audio webcast of the corporate presentation will be available on Protalix’s website at
www.protalix.com under the events calendar section.
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 is safe and scalable and will allow for the
cost-effective, industrial-scale production of recombinant therapeutic proteins. Protalix is
enrolling and treating patients in its pivotal phase III clinical trial in Israel, the United
States and other locations for its lead product candidate, prGCD, for its enzyme replacement
therapy for Gaucher disease, a lysosomal storage disorder in humans, and 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 is also
advancing additional recombinant biopharmaceutical drug development programs.
Contact:
Marcy Strickler
The Trout Group, LLC
Telephone: 646-378-2927
Email: mstrickler@troutgroup.com
Marcy Strickler
The Trout Group, LLC
Telephone: 646-378-2927
Email: mstrickler@troutgroup.com
Exhibit 99.2
Protalix BioTherapeutics Provides Enrollment Update for
the Phase III Clinical Trial of prGCD
the Phase III Clinical Trial of prGCD
CARMIEL, Israel, September 22, 2008 — Protalix BioTherapeutics, Inc. (Amex: PLX), today announced
that the Company anticipates completion, during the second half of 2008, of enrollment in its
on-going pivotal phase III clinical trial of prGCD, a proprietary plant cell expressed recombinant
form of human Glucocerebrosidase (GCD) for the treatment of Gaucher disease. Currently, clinical
trial sites that are participating in the trial are recruiting patients in Europe, the United
States, Israel and other countries.
“We are pleased to announce that, to date, we have enrolled more than 75% of the patients required
for our phase III clinical trial for prGCD,” said Dr. David Aviezer, President and Chief Executive
Officer of the Company. “Given the recent and current rates of patient screening and recruitment,
we anticipate that we will soon be able to complete enrollment for this study. We expect to submit
a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) in the
second half of 2009. In addition, we are very encouraged by the fact that Gaucher disease patients
that have completed our phase III clinical trial have chosen to continue to be treated with prGCD
as part of our on going follow-on extension study.”
The pivotal phase III clinical trial of prGCD is a multi-center, randomized, double-blind, parallel
group, dose-ranging trial to assess the safety and efficacy of prGCD in 30 naive patients suffering
from Gaucher disease. In the trial, patients are selected randomly for one of two dosing arms and
receive IV infusions every two weeks for nine months. The primary endpoint of the study is the
percent change in spleen volume from baseline, as measured by MRI.
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 enrolling and treating patients in its
pivotal phase III clinical trial in Europe, the United States, Israel, and other locations for its
lead product candidate, prGCD, for its enzyme replacement therapy for Gaucher disease, a lysosomal
storage disorder in humans, and 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 is also advancing additional recombinant
biopharmaceutical drug development programs. For more information, please
visit our website at www.Protalix.com.
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 such a material difference include, among others, uncertainties
related to the ability to attract and retain partners for our technologies and products under
development, the identification of lead compounds, the successful preclinical development of our
products, the completion of clinical trials, the review process of the FDA, foreign regulatory
bodies and other governmental regulation, and other factors described in our filings with the
Securities and Exchange Commission. The statements are valid only as of the date hereof and we
disclaim any obligation to update this information.
Contact:
Marcy Strickler
The Trout Group, LLC
Telephone: 646-378-2927
Email: mstrickler@troutgroup.com
Marcy Strickler
The Trout Group, LLC
Telephone: 646-378-2927
Email: mstrickler@troutgroup.com