We are a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins through our ProCellEx® plant cell-based protein expression system. Using ProCellEx, we are developing a proprietary pipeline of proprietary, clinically superior versions of recombinant therapeutic proteins, based on our plant cell-based expression technology, that primarily target large, established pharmaceutical markets and that rely in most cases upon known biological mechanisms of action. Our initial commercial focus has been on complex therapeutic proteins, including proteins for the treatment of genetic disorders, such as Gaucher disease and Fabry disease. With our experience, and having successfully developed ELELYSO™ (taliglucerase alfa for injection), our first drug product, we believe ProCellEx will enable us to develop additional proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications. Elelyso is the first plant cell-based recombinant therapeutic protein approved by the U.S. Food and Drug Administration (FDA). Because we are primarily targeting biologically superior versions of highly active, well-tolerated and commercially successful therapeutic proteins, we believe our development process is associated with relatively less risk compared to other biopharmaceutical development processes for completely novel therapeutic proteins. We are now also applying the unique properties of our ProCellEx system for the oral delivery of therapeutic proteins.
ELELYSO™ (taliglucerase alfa for injection) was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. In Latin America, Elelyso is marketed as UPLYSO™ (alphataliglicerase).
In October 2015, we entered into an amended agreement with our commercialization partner for taliglucerase alfa, Pfizer Inc., pursuant to which we licensed to Pfizer the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where we retain full rights.