UNITED STATES
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
Date of Report (Date of earliest event reported): May 3, 2007
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.) |
(Former Name or Former Address, if Changed Since Last Report)
Registrants 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 7.01. Regulation FD Disclosure
On May 3, 2007, Protalix BioTherapeutics, Inc. (the Company) issued a press release to announce that the Company would present at the Biotechnology Industry Organizations (BIO), 2007 International Convention being held at the Boston Convention & Exhibition Center, Boston, Massachusetts, on May 7, 2007. The full text of the press release is set forth in Exhibit 99.1.
A copy of the Companys presentation materials for the convention, appearing in Exhibit 99.2, is furnished and not filed pursuant to Regulation FD.
Item 9.01. Financial Statements and Exhibits
(d) | Exhibits |
99.1 | Press release dated May 3, 2007, titled Protalix BioTherapeutics to Present at the BIO International Convention on May 7, 2007. |
99.2 | Slide Presentation to be used at the Biotechnology Industry Organizations (BIO), 2007 International Convention on May 7, 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: May 4, 2007 | By: | /s/ David Aviezer |
||
Name: Title: |
David Aviezer, Ph.D.
President and Chief Executive Officer |
2 |
Exhibit 99.1
Protalix BioTherapeutics to Present at the BIO International Convention on May 7, 2007
CARMIEL, Israel, May 3, 2007 - Protalix BioTherapeutics (AMEX: PLX) today announced that Dr. David Aviezer, President and Chief Executive Officer, will present at the Biotechnology Industry Organizations (BIO), 2007 International Convention on Monday, May 7, 2007 at 10:20 a.m. EDT, at the Boston Convention &Exhibition Center, Boston, Massachusetts.
Dr. Aviezer will present Protalixs proprietary and innovative underlying platform technology, as well as recent advances in the clinical development of prGCD, its lead product for treating Gaucher Disease.
The Convention will feature a program packed with more than 200 sessions and speakers focusing on the global aspects of biotechnology. More than 20,000 leaders from across the industry are expected to be in attendance. Additional information is available at www.bio2007.org.
About Protalix BioTherapeutics, Inc.
Protalixs 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. Protalixs 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; any 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 operations of regulatory authorities, our subsidiaries, our manufacturing facilities and our customers, suppliers, distributors, couriers, collaborative partners, licensees, and clinical trial sites; 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.
For additional information, contact:
Protalix Investor Relations: investors@protalix.com
AMEX IR Alliance for Protalix:
Lee Roth / David Burke
212-896-1209
/ 212-896-1258
lroth@kcsa.com / dburke@kcsa.com
Exhibit 99.2
Novel and Biogeneric Protein
Therapeutics
BIO
International
Convention
May 7, 2007
Dr. David Aviezer
President & CEO
Safe Harbor Statement
To the extent that statements in this document 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.
About Protalix
Protalix has developed a proprietary plant cell culture
technology and innovative bioreactor system for the efficient
and safe, large-scale production of complex human therapeutic
proteins
in plant cells.
The company's platform technology is designed to
produce a range of human protein therapeutics for the bio-
pharmaceutical
market.
The lead product, prGCD, Glucocerebrosidase enzyme, for
treating Gaucher Disease, targets
a $1 billion market and is
scheduled to initiate Phase III clinical trial in mid 2007.
Company Highlights
Product-driven strategy: lead product, prGCD, Glucocerebrosidase
for treating Gaucher Disease,
targets a $1
billion market.
prGCD - scheduled to initiate Phase III in 2007.
Pipeline includes novel and biogeneric therapeutic proteins.
Strong IP positioning based on proprietary protein manufacturing
platform in plant cell
culture with advantages in terms of the
glycosylation process, cost-effectiveness and safety.
Experienced Management Team led by board members such as Mr.
Eli Hurvitz, Chairman of Teva, and Dr. Phillip Frost, current Vice
Chairman of Teva and former Chairman and CEO of IVAX.
Partnership strategy:
generating alliances with biopharmaceutical
and large cap pharmaceutical companies.
Protalix BioTherapeutics, Inc. - Publicly traded on the
American Stock Exchange (AMEX: PLX).
Board of Directors
Mr. Eli Hurvitz - Chairman of Protalixs BOD; Chairman, Teva Pharmaceutical Industries
Dr. Phillip Frost - Vice Chairman Teva; Former Chairman & CEO, IVAX Corp.
Mr. Zeev Bronfeld - CEO, Biocell
Mr. Amos Bar-Shalev - Director, Technorov VC fund
Dr. Jane Hsiao - Former Vice Chairman, IVAX Corp.
Mr. Eyal Sheratzki - Co-CEO, Ituran
Gen. (res.) Pinchas Buchris - Managing Director, Tamares, Venture Partner, APAX
Mr. Sharon Toussia-Cohen - CEO, Marathon VC fund
Dr. Yoseph Shaaltiel - Founder & E.VP of R&D, Protalix
Dr. David Aviezer - President & CEO, Protalix
Protalix Pipeline
PhaseIII
prGCD II
PRX- 103
PRX-111
PRX-102
prGCD
NDA
Phase II
Phase I
Preclinical
Validation
**
- Denotes projected pipeline status during 2007
**- prGCD Phase II has been waived by FDA
Target selection-Global strategy
First target: Gaucher Disease.
Think Big and Globally,
for a well
established and lucrative market, but seek a
Small niche market as
to number of
patients, treatment centers, marketing
efforts, etc.
Seek Global
collaboration partners for large
patient population targets.
prGCD for treating Gaucher
Disease: Highlights
Well established, lucrative
billion dollar
niche market with
wide profit margins. Cerezyme® produced in mammalian cells,
generated 2006 sales
of $ 1 Billion,
without
competition on the
market (Source:
Genzyme announcement 2007)
FDA- approved clinical regulatory path:
Phase I: completed
Phase II: waived by FDA
Phase III: initiation -mid 2007
Proven superior bioactivity in various models
Strong IP positioning due to circumvention of patents
prGCD clinical grade production serves as major proof of concept
for Protalixs platform
prGCD: Equal to Superior
Biological Activity
0
25
50
75
100
125
0
1
2
Cerezyme
prGCD
S, uM
prGCD has superior enzymatic activity degrading the natural substrate
when compared to Cerezyme®
:
Gaucher patients macrophages
model: prGCD demonstrates superior
uptake vs. Cerezyme® following 24
and 48 hours of incubation
Enhanced uptake of prGCD by
mouse
macrophages compared to
Cerezyme®:
Similar three dimensional
structure
Three dimensional crystal
structure of prGCD solved
by a team of world
renowned scientists from the
Weizmann Institute of
Science is comparable to
Cerezyme®
structure
Regulatory Development -
Global Thinking
First target: Gaucher Disease
Meet with FDA very early in the process.
Gain insight as to what the regulatory
global real world will require, as early
as possible in the development stage of
your drug candidate.
Perform clinical studies globally.
prGCD Phase I Study:
Summary
Safety study of three single escalating doses administered as intravenous
infusions in healthy volunteers.
Design: Single-center, non-randomized, open label performed at Hadassah
Medical Center,
Jerusalem, Israel.
Study performed under FDA IND approval.
Results: Treatment successfully completed:
prGCD was well tolerated.
Highly satisfactory safety lab results.
Pharmacology prolonged half life of drug in serum.
Final report submitted.
Comparison of PK data:
prGCD vs. Cerezyme®
prGCD data:
Preclinical-Primates
T1/2~13-20 minutes
Phase I: Human data:
T1/2~10.5-14.5 minutes
Cerezyme (published data):
Preclinical-Primates:
T1/2~ 6.8-8 minutes
Human data
T1/2~3.6-10.4 minutes
Multi-center world wide study: efficacy
and safety in
untreated patients with
significant symptoms of Gaucher Disease.
Protocol outline reviewed by FDA:
randomized, double blind, parallel groups,
dose-ranging study.
Measurable efficacy end point.
prGCD Phase III: Study Design
Phase III Milestones
Israel Ministry of Health
approval to initiate
Phase III study
FDA approval to
initiate Phase
III study
- Initiate Phase III trial
Plant Cell Technology Demonstration
The Technology Platform
Expression of recombinant
human proteins in a
proprietary plant cell
bioreactors:
safe
simple to handle
friendly to plant cell growth
cost efficient
easily up-scalable
Built in line with FDA
guidelines and GMP
standards
Protalix Manufacturing Facility:
~
5000 Sq/ft. of clean rooms
Follicle Stimulating Hormone
Follicle-Stimulating Hormone (FSH)
regulates several major reproductive
functions of the human female body
(IVF).
Growing $1 billion market.
Protein consisting of a common alpha
subunit non-covalently bound to a beta
subunit.
Protalix is also co-developing a
proprietary variant of FSH with
Compugen.
IgG1-CHO
IgG4-Protalix
*
IgG1-Protalix
Control
FACS Analysis of Protalix IgG1
and IgG4 Abs Binding to Jurkat
Leukemia Cells- Compared to
CHO IgG1:
Heavy Chain
Light Chain
Human IgG
Standard
Recombinant
IgG produced by
Protalixs plant
culture system
Monoclonal Antibodies:
Proof of concept
Protalix system may represent an
alternative platform for hard-to-
express proteins in mammalian
systems, including some monoclonal
antibodies
Two-Armed Business Model
Share risks and profits by
forming
early-stage co-
development
partnering
deals for biotherapeutic
proteins
Examples: TEVA
Internal development of
Protalixs
proprietary
specialty market
oriented
therapeutic proteins into
advanced commercial
stage
Example: prGCD, for
treating Gaucher Disease
Partnership Validation
2006- Teva Pharmaceutical
Industries:
Agreement for co-development of
two therapeutic proteins
2005-
Bayer (Icon Genetics):
License agreement for
complementary technology
Protalix is constantly
seeking new value-
adding partnerships
Global Financial Strategy
Use non-equity funding from sources such as
Israeli chief scientist governmental grants at
early stage.
Bring in top-tier early stage US and global investors
early in the financing process.
Select late stage investors with global perception of
capital markets and the pharmaceutical arena.
Increase financial and strategic visibility by becoming
public in the US (AMEX:PLX).
Innovative and Biogeneric
Protein Therapeutics
Contact:
Dr. David Aviezer
President & CEO
david@protalix.com
Thank
You!