Welcome and thank you for visiting Symphogen’s website. Symphogen is a biotechnology company that is developing recombinant polyclonal antibodies for the treatment and prevention of disease. Our website will provide you information on not only our Company, but also on our unique antibody discovery and manufacturing technologies, our pipeline of recombinant polyclonal antibody product candidates, the therapeutic areas that we are working in, and the advantages of recombinant polyclonal antibodies over other therapeutics.
| CEO Kirsten Drejer |
 |
Again in 2007, antibody therapeutics were a major focus of new products and partnerships in the bio-technology industry. Many large pharmaceutical companies competed to fill their pipelines, and antibodies continue to be on the top of their shopping lists. Antibody therapeutics are forecasted to be the most commercially attractive pharmaceutical product segment, expected to grow from USD 20 billion in 2006 to approx. 40 billion by 2012.
The focus on antibody therapeutics has led to a continuation of the acquisitions seen in 2006, resulting in some of the largest R&D collaborations and acquisitions in the history of the biotechnology industry. Since many of the independent antibody platform companies and small companies active within discovery and development of antibodies have been acquired, we believe our future partnering opportunities look increasingly attractive.
2007 became the year in which we were able to establish ‘proof-of-company’ for Symphogen in that we initiated Phase 1 clinical trials in the U.S. for the first-in-class
recombinant polyclonal antibody product. The product candidate, Sym001, is a recombinant polyclonal antibody composition consisting of 25 different anti-Rhesus D antibodies. Sym001 is in development for the treatment of Idiopathic/Immune Thrombocytopenic Purpura (ITP) and for Anti RhD prophylaxis (ADP) of hemolytic disease of the newborn. A total of 59 RhD-positive (to support further studies in ITP) and 18 RhD-negative (to support further studies in ADP) healthy volunteers were enrolled, and the results from the dose-escalation, placebo-controlled study showed that Sym001 is well tolerated. Together with our co-development and commercialization partner Biovitrum, we are preparing to initiate Phase 2 and eventually Phase 3 clinical studies.
In 2007, we also made significant progress with our additional pipeline candidates, and two of the programs, Sym003 and Sym004, were matured from discovery phase into pre-clinical development.
The Sym003 product candidate targets a blockbuster market for prophylaxis of Respiratory Syncytial Virus (RSV) infections in premature babies, and has shown promising pre-clinical in-vivo results. Compared to the marketed product, Synagis®, and an analogue of a follow-on product, we saw significantly better effect with Sym003 in an animal model, and these results were positively received when presented at two international scientific conferences.
The Sym004 product candidate holds high future prospects as an oncology drug candidate as it targets a validated oncology antigen, and addresses an established blockbuster market. During 2007, Sym004 performed favorably when compared to marketed products in early pre-clinical in-vivo models, and most importantly, the candidate performed with a unique mechanism of action.
The Symplex™ discovery technology continued to deliver high quality antibody leads in 2007, cloned from human donor materials and in a very short period of time. This technology platform has now been validated through more than six infectious disease targets and several oncology targets with truly remarkable results.
During 2007, we initiated a partnership with Japanese pharmaceutical company, Meiji Seika Kaisha, on an undisclosed bacterial target. The synergy between Meiji’s extensive knowledge within the infectious disease area combined with Symphogen’s powerful antibody technology platforms lead to the achievement of significant progress during this project’s first year of discovery.
In November, Symphogen was awarded ‘Best Biotech Company in Denmark’ at the Ernst & Young Entrepreneur of the Year event. It was justified not only by a pioneering antibody platform technology and a maturing pipeline, but also by the quality of the workforce and the unique company culture that has evolved.
Consequently, I want to take this opportunity to thank all employees at Symphogen for their great achievements during the year and for their will and commitment to constantly take on new challenges as our products mature through the development stages. Finally, without the continued and strong support from our high quality investors we would not have been able to bring the first recombinant polyclonal product into human trials. Thank you!
Kirsten Drejer, Ph.D.
Chief Executive Officer
Products
Therapeutic Areas