UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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Date of Report (Date of earliest event reported): April 18, 2007
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
Florida 000-27836 65-0643773
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 21000
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(Address of principal executive offices) (Zip Code)
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(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):
|_| Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
|_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|_| Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
|_| Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events
On April 18, 2007, Protalix BioTherapeutics, Inc. (the "Company") issued a press
release announcing that had received written notice from the United States Food
and Drug Administration that it may initiate a Phase III clinical trial in the
United States of its lead product candidate, prGCD.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
99.1 Press release dated April 18, 2007
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: April 18, 2007 By: /s/ David Aviezer
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Name: David Aviezer, Ph.D.
Title: President and
Chief Executive Officer
2
Exhibit 99.1
Protalix BioTherapeutics, Inc. Receives Approval
from the FDA to Initiate a Phase III Clinical Trial of prGCD
Phase III clinical trial may commence shortly
Carmiel, Israel - April 18, 2007 - Protalix BioTherapeutics, Inc. (AMEX: PLX)
today announced that it has received written notice from the United States Food
and Drug Administration (FDA) that it may initiate a Phase III clinical trial in
the United States of its lead product candidate, prGCD, a proprietary plant cell
expressed recombinant form of human Glucocerebrosidase (GCD), for the treatment
of Gaucher Disease, a lysosomal storage disorder in humans.
The FDA has allowed the Company to directly initiate Phase III based upon the
results of the Company's pre clinical and Phase I clinical trials of prGCD. The
Company presented the completed data from its Phase I clinical trial at the
European Working Group of Gaucher Disease (WEGGD) in Cambridge, United Kingdom
in July 2006.
The Company hopes to commence the Phase III clinical trial shortly. The trial
will take place in centers in the United States, Israel, where approval from the
Israeli Ministry of Health has been received, and other locations worldwide. The
study will initially consist of male and female adult patients with Gaucher
Disease.
David Aviezer, Ph.D., President and Chief Executive Officer of Protalix
BioTherapeutics, commented, "The receipt of the FDA's approval to initiate a
Phase III clinical trial of prGCD represents an important milestone in the
development of this product, and we are excited about the progress we have made
thus far. Following the success of our Phase I trial and our promising pre
clinical and biochemical data, we believe that we will continue to see positive
results from our patients in Phase III."
Dr. Aviezer continued, "We remain deeply committed to the development of a
treatment for Gaucher Disease and are excited by the opportunity to commence the
Phase III trial and working with the medical experts and patient community."
About Protalix BioTherapeutics, Inc.
Protalix's proprietary technology is based on its plant cell culture and
bioreactor system, which provides an effective and scaleable cell system for
industrial production of recombinant biopharmaceuticals. Protalix is pursuing
advanced clinical studies for its enzyme therapy for Gaucher Disease and intends
to advance additional recombinant biopharmaceutical drug development programs.
The Company believes its plant-based expression has significant advantages over
more traditional mammalian and bacterial expression technology with respect to
patient safety, cost and scalability.
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, the inherent risks and uncertainties
in developing drug platforms and products of the type we are developing; delays
in our preparation and filing of applications for regulatory approval; delays in
the approval or potential rejection of any applications we file with the FDA, or
other health regulatory authorities; lack of progress of our research and
development (including the results of clinical trials being conducted by us);
obtaining on a timely basis sufficient patient enrollment in our clinical
trials; the impact of development of competing therapies and/or technologies by
other companies; our ability to obtain additional financings required to fund
our research programs; our ability to establish and maintain strategic license,
collaboration and distribution arrangements and to manage our relationships with
collaborators, distributors and partners; potential product liability risks and
risks of securing adequate levels of product liability and clinical trial
insurance coverage; the possible disruption of our operations due to terrorist
activities and armed conflict, including as a result of the disruption of our
subsidiary, our manufacturing facilities, collaborative partners, licensees, and
clinical trial sites; and other factors described in our filings with the
Securities and Exchange Commission. The statements are accurate only as of the
date hereof and we disclaim any obligation to update this information, except as
required by law.
For additional information, contact:
Protalix Investor relations: investors@protalix.com
++972-4-988-9488
AMEX IR Alliance for Protalix:
Lee Roth / David Burke
212-896-1209 / 212-896-1258
lroth@kcsa.com / dburke@kcsa.com