Proprietary Protein Therapeutics with Clinically Improved Profiles
Protalix is a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by our proprietary ProCellEx® plant cell-based protein expression system. Our pipeline consists of proprietary, potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets.
Track record of success
Protalix was founded by Dr. Yoseph Shaaltiel and began as a greenhouse company in Israel’s northern town of Kiryat Shmona, in 1993. The first manufacturing facility was constructed in May 2004 in Carmiel in the Western Galilee, which was later expanded and upgraded at the end of 2009 in preparation for the commercial production of Elelyso® and production of pipeline candidates for clinical trials. We maintain the highest global quality of product and quality assurance standards. Our cGMP manufacturing facility has been successfully inspected and audited by multiple regulatory agencies including the US FDA, EMA, Australian TGA, Brazilian ANVISA, and the Israeli Ministry of Health.
Protalix is proud to be the first company to gain FDA approval for a plant cell culture expressed protein. Elelyso® (taliglucerase alfa for injection) is Protalix’s first drug product produced by its proprietary ProCellEx® protein expression system, and was approved for marketing by the FDA in May 2012, followed soon after by approval by ANVISA in Brazil, Israel’s Ministry of Health, and other regulatory authorities around the world. For more information about Elelyso®, please visit http://www.elelyso.com
Protalix’s ProCellEx® platform has the ability to manufacture complex proteins, antibodies, and vaccines and has the ability to orally deliver certain therapeutic proteins as demonstrated in animal models.
Moving forward: Leveraging the benefits of our platform technology
We will continue to leverage multiple unique advantages of the proprietary plant cell culture expression technology platform:
- We have internal capabilities to improve biologic dynamics (e.g., glycosylation, half-life extension) of a protein and have been successful in leveraging these capabilities in the current pipeline.
- We can develop and commercialize recombinant proteins without infringing upon the method-based patents or other intellectual property rights of third parties
- Our platform has the ability to express certain proteins that are difficult to express in other systems.
- Our system enjoys a lower cost of scale-up (CapEx) and production.
- Through our system we have the ability to more rapidly develop a protein for clinical testing versus other protein platforms.
Protalix’s vision is to become a fully integrated biopharmaceutical company leveraging the advantages of our
unique technology platform and internal research and development capabilities