Protalix BioTherapeutics, Inc. (de) · AMEX:PLX
Protalix BioTherapeutics, Inc. (de) — BIO International Convention 2007
24 slides from Protalix BioTherapeutics, Inc. (de)'s conference presentation, May 4, 2007
Slide 1: Exhibit 99.2
Exhibit 99.2
Slide 2: BIO International Convention: Novel and Biogeneric Protein Therapeutics
BIO International Convention May 7, 2007 Dr. David Aviezer President & CEO Novel and Biogeneric Protein Therapeutics
Slide 3: Safe Harbor Statement
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 kno
Slide 4: About Protalix
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 protei
Slide 5: Company Highlights
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 pro
Slide 6: Board of Directors
Board of Directors Mr. Eli Hurvitz - Chairman of Protalix’s 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
Slide 7: Protalix Pipeline
Protalix P ipeline 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
Slide 8: Target selection-Global strategy
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
Slide 9: prGCD for treating Gaucher Disease: Highlights
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 r
Slide 10: prGCD: Equal to Superior Biological Activity
prGCD: Equal to Superior Biological Activity 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 u
Slide 11: Similar three dimensional structure
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
Slide 12: Regulatory Development - Global Thinking
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.
Slide 13: prGCD Phase I Study: Summary
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: Treatm
Slide 14: Comparison of PK data: prGCD vs. Cerezyme
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
Slide 15: prGCD Phase III: Study Design
prGCD Phase III : Study Design 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.
Slide 16: Phase III Milestones
Phase III Milestones Israel Ministry of Health approval to initiate Phase III study FDA approval to initiate Phase III study - Initiate Phase III trial
Slide 17: Plant Cell Technology Demonstration
Plant Cell Technology Demonstration
Slide 18: The Technology Platform: Protalix Manufacturing Facility
The Technology Platform Protalix Manufacturing Facility: ~ 5000 Sq/ft. of clean rooms 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 stan
Slide 19: Follicle Stimulating Hormone
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
Slide 20: Monoclonal Antibodies: Proof of concept
Monoclonal Antibodies: Proof of concept Protalix system may represent an alternative platform for hard-to- express proteins in mammalian systems, including some monoclonal antibodies IgG1-CHO IgG4-Protalix * IgG1-Protalix Control FACS Analysis of Protalix IgG1 and IgG4 Ab’s Binding to Jurkat Leukemi
Slide 21: Two-Armed Business Model
Two-Armed Business Model Share risks and profits by forming early-stage co- development partnering deals for biotherapeutic proteins Examples: TEVA Internal development of Protalix’s proprietary specialty market oriented therapeutic proteins into advanced commercial stage Example: prGCD, for treatin
Slide 22: Partnership Validation
Partnership Validation Protalix is constantly seeking new value- adding partnerships 2006- Teva Pharmaceutical Industries: Agreement for co-development of two therapeutic proteins 2005- Bayer (Icon Genetics): License agreement for complementary technology
Slide 23: Global Financial Strategy
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 pharma
Slide 24: Thank You!
Thank You! Innovative and Biogeneric Protein Therapeutics Contact: Dr. David Aviezer President & CEO [email protected]
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