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Copenhagen, Denmark (23 August 2005): Symphogen A/S, a biotechnology company pioneering recombinant human polyclonal antibodies for the treatment and prevention of human disease, announced today that it has entered into a patent license agreement with Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG). Under the terms of the agreement, Symphogen receives a license to use CAT´s antibody phage display patents for research purposes and to develop and commercialize a number of therapeutic and diagnostic antibody products. Upon signing the agreement, Symphogen made an upfront payment for the license and exercised its first product license option to develop and commercialize its lead product Sym001. As a condition of exercising this option, Symphogen paid a product license fee and may make future milestone and royalty payments to CAT. Sym001 is a recombinant, fully human, anti Rhesus D polyclonal antibody which Symphogen is developing for Idiopathic Thrombocytopenic Purpura (ITP) and Hemolytic Disease of Newborns (HDN). The Company plans to file an IND for initiation of Phase I clinical trials in 2006. Kirsten Drejer, CEO of Symphogen, commented: "We are very pleased to have secured access to Cambridge Antibody Technology’s validated phage display patent estate. Combined with our proprietary antibody technology, Symphage™, this strengthens our competitiveness in the antibody arena. This partnership with CAT further supports the clinical development and commercialization of our lead product, Sym001, for the treatment of ITP and HDN. Our strategy is to build a strong portfolio of therapeutic recombinant polyclonal antibodies through our internal efforts and in collaboration with partners.” -ENDS- For more information about Symphogen A/S, please contact: Kirsten Drejer, CEO, Symphogen A/S: +45 45 26 50 59, kd@symphogen.com Thomas Feldthus, CFO, Symphogen A/S: +45 45 26 50 55, tf@symphogen.com Katja Stout / Christelle Kerouedan, Northbank Communications: +44 207 886 8150, c.kerouedan@northbankcommunications.com . Notes to Editors: About Sym001 – recombinant human polyclonal anti-Rhesus D antibodies Sym001 is composed of 25 recombinant RhD-specific fully human polyclonal IgG1 antibodies. Sym001 is cloned from human hyperimmune donors using the Symphage™ technology and manufactured using the Sympress™ expression technology. Sym001 is developed as a liquid formulation for prophylaxis of ITP in non-splenectomized, Rhesus D positive adults and for Hemolytic Disease of Newborns. The dosage and treatment regimens of Sym001 are expected to be similar to existing, serum-derived anti-D products. About Idiopathic Thrombocytopenia Purpura, ITP ITP is an autoimmune disease characterized by spontaneous subcutaneous bleeding due to the presence of autoantibodies against blood platelets. These antibodies mediate platelet clearance from the circulation resulting in subcutaneous and internal bleedings. Untreated ITP can be fatal. Adult ITP typically arises without any pre-warning symptoms and then runs a chronic course. The incidence of adult chronic ITP is 58-66 cases/million/year and affects between 31,000 – 36,000 individuals/year in the US and Western Europe. Currently ITP is treated with corticosteroids or unspecific intravenous immunoglobulin (IVIg). While the former treatment is cost-effective it produces severe side effects and the latter treatment, is expensive and difficult to administer. Blood plasma-derived polyclonal immunoglobulin preparations against RhD, anti-D, provide a second line therapeutic for use in patients. These Anti-D immunoglobulins are well positioned to replace IVIg in Rhesus D positive adults, however, being purified from pooled human blood, serum associates them with disadvantages i.e. insufficient availability and the risk of transferring human pathogens to patients. Thus, recombinant human polyclonal anti-D products, such as Sym001, will potentially secure a steady and safe supply of anti-D products for ITP treatment. About Hemolytic Disease of the Newborn, HDN HDN is a life threatening disorder, which is caused by maternal immunization against fetal Rhesus D (RhD) blood group antigens during pregnancy or delivery. Approximately 16% of the Caucasian population is RhD-negative (RhD-). This condition is not associated with any medical symptoms, but has important medical implications when an RhD- female carries a RhD positive (RhD+) fetus. If fetal erythrocytes enter the maternal circulation i.e. during delivery, this elicits a maternal anti-RhD antibody response. In subsequent pregnancies with a RhD+ fetus, the maternal immune system will be primed to produce RhD-specific antibodies, that will cross the placenta and eventually cause destruction of the fetal erythrocytes, the hallmark of HDN. Approximately 20% of non-treated RhD- women delivering a RhD+ infant for the second time generate an anti-Rhesus D antibody response. When untreated, approximately 80% of the affected newborns will have moderate anemia, jaundice, and hepatomegaly. The remaining 20% develop severe anemia and hydrops foetalis, and severely affected newborns are at risk of neonatal death or permanent handicaps. Blood plasma-derived polyclonal immunoglobulins against RhD, anti-D, are used to prevent pregnant RhD- women being immunized by their fetus. While efficacious, optimal treatment cannot be implemented due to insufficient availability of anti-D immunoglobulins, also these products carry the risk of transmitting human pathogens to the pregnant mother. Thus, recombinant human polyclonal anti-D products will potentially secure a steady and safe supply of anti-D products for the treatment of HDN. About Symphogen Symphogen A/S is a biotechnology company pioneering therapeutic products based on natural human antibodies for the treatment and prevention of human disease. Using its proprietary technologies, Symphogen aims to develop and eventually market unique antibody-based products that mimic the diversity, affinity, and specificity of the natural human immune system. Antibody drug candidates are generated using either the Symplex™ or the Symphage™ technologies and the selected lead candidate may be polyclonal or monoclonal, depending on the nature of the target. The Company applies its proprietary expression platform, the Sympress™ technology, for consistent manufacturing of recombinant polyclonal antibody compositions, termed symphobodies. Symphobodies offer a number of advantages over current plasma-derived immunoglobulins and monoclonal antibody therapies for the treatment of diseases characterized by complex target antigens, such as those found in infectious diseases, allergy, transplant rejection, and cancer. For more information, please visit www.symphogen.com. About Cambridge Antibody Technology CAT is a leading biopharmaceutical company, committed to developing fully human monoclonal antibody therapeutics to treat human diseases in areas of unmet medical need. For more information, please visit www.cambridgeantibody.com. |
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