Welcome and thank you for visiting Symphogen’s website. Symphogen is a biotechnology company that is developing recombinant antibody therapeutics for the treatment and prevention of disease. Our website will provide you information on our Company, and on our unique antibody discovery and manufacturing technologies, our pipeline of recombinant antibody product candidates, the therapeutic areas that we are working in, and the advantages of recombinant antibodies, in particular recombinant polyclonal antibodies, over other therapeutics.
CEO Kirsten Drejer
Antibody therapeutics is a major focus of new products and partnerships in the biotechnology industry. Antibody therapeutics are forecasted to be the most commercially attractive pharmaceutical product segment, expected to grow from USD 33 billion in 2008 to approximately USD 50 billion by 2013.
The financial crisis and economic recession has put even more pressure on the pharmaceutical industry to provide attractive shareholder value. At the same time many large pharmaceutical companies are faced with product pipelines running out of patent protection within the next 3-5 years. They have communicated new long-term strategies calling for innovative products, and during the year they have competed to fill their pipelines with antibodies continuing to be at the top of their shopping lists. During the past couple of years many independent antibody platform companies and small companies active within discovery and development of antibodies have been acquired, and, I believe, Symphogen has consequently become increasingly attractive to the industry due to its totally independent antibody technology platform as well as its product pipeline, which includes a Phase 2 clinical product opportunity and three potential blockbuster products in pre-clinical development.
2008 marked a successful year for Symphogen with the achievement of several important milestones.
Preliminary safety and efficacy data were reported for our lead product, rozrolimupab (Sym001), a recombinant polyclonal antibody product consisting of twenty five different Rhesus D specific antibodies. Rozrolimupab progressed into Phase 2 clinical trials for two different indications; treatment of idiopathic thrombocytopenic purpura (ITP) and prevention of hemolytic disease of the newborn (HDN) through anti-D prophylaxis (ADP). A successful meeting was held with the FDA and a regulatory path established for this new class of antibody therapeutics. Furthermore, during 2008 the United States Adopted Names Council adopted rozrolimupab as the generic name for Sym001, making it the first product named with the stem, or suffix, “..pab” recognizing recombinant polyclonal antibodies as a therapeutic class.
During 2008 we were able to generate convincing pre-clinical in vivo data for our antibody product, Sym004, targeting the HER-1 receptor (EFGR) and a unique mechanism of action was identified. In addition, we have acquired the technology and programs of Receptor BioLogix including its pan-HER ligand trap program, RBLX-242, which targets growths factors that bind to the HER family of receptors.
In addition, we have generated additional pre-clinical in vivo data for our recombinant polyclonal antibody product against respiratory syncytial virus (RSV), Sym003. We were able to distinguish the product from the marketed monoclonal antibody product and are confident that a combination of antibodies targeting both the F- and G-antigens on the surface of the virus will provide a superior product opportunity.
The collaboration with Meiji Seika Kaisha aiming to generate a lead product for the treatment of an undisclosed bacterial infection progressed smoothly and entered the pre-clinical development stage during 2008, and consequently a milestone payment was received.
Symphogen’s technology platforms were strengthened further and the SymplexTM discovery platform was adapted to several species. The SympressTM expression platform was successfully developed with significant improvement in production yields while still keeping a remarkable batch-to-batch consistency. Finally, advanced protein chemistry methods were developed which allows quantitative analyses of products containing compositions of antibodies.
2008 was also the year where Symphogen entered into a strategic deal with Genentech for the development of recombinant antibody products towards three undisclosed infectious disease targets. This represents a very important external validation of our technology platform, since Genentech is widely viewed as a leader in the development of antibody therapeutics.
Despite the global financial crises and the challenging financial environment, Symphogen secured a financing of DKK 245 million (EUR 33 million) in January 2009 at a two-fold valuation compared to December 2006. The proceeds from this financing will support the Company’s activities well into 2011. The size of the organization was adapted to the focused activities going forward and head count had to be reduced by 20% in November.
I want to take this opportunity to thank all employees at Symphogen, including those we regrettably had to let go, for their substantial achievements during the year and for their commitment to take on new challenges as our products mature through the development stages. Finally, without the continued and strong support, including financial support, from our high quality investors we would not have been able to mature a pipeline consisting of two Phase 2 clinical trials and three block-buster products in pre-clinical development. Thank you!
