Biovitrum and Symphogen enter co-development and commercialization agreement for recombinant polyclonal antibodies for the treatment of certain blood disorders

Symphogen A/S, Denmark and Biovitrum AB, Sweden have entered into a co-development and commercialization agreement for Sym001, Symphogen’s lead product. Sym001 is a combination of 25 different recombinant anti-Rhesus D antibodies for the treatment of both Idiopathic Thrombocytopenic Purpura (ITP) and Hemolytic Disease of the Newborn (HND).

Under the terms of the new collaboration agreement, Symphogen receives an initial technology access fee from Biovitrum and will receive milestone payments based on the progress of the program. Symphogen will be responsible for marketing in North America, Central America and South America, and Biovitrum for Europe, Russia and the Middle East. The companies will seek partners for remaining rest of world markets. The companies will equally share the costs for developing anti-RhD and will divide future commercial profits evenly. Additional financial terms will not be disclosed. Manufacture of Sym 001 has been successfully scaled up under good manufacturing practice (GMP) conditions at Biovitrum that, prior to this agreement, has been contract manufacturing the product for initial clinical trials. Clinical trials will commence in 2006. The total global market for the ITP indication is estimated to be worth about USD 500 million annually and for the HDN indication about USD 200 million per year. We are pleased to be able to develop Sym001 together with Symphogen. Their technology has resulted in a very promising product that meets the changing demands on the market and has the potential to provide a safer and more convenient treatment than compared to alternative therapies for these blood diseases. This strategic collaboration further consolidates our strength in protein based drugs and haematology, where we have significant experience and interests,” commented Mats Pettersson, CEO of Biovitrum. – We are pleased that Biovitrum has chosen to become our co-development and commercialization partner for this program which will be the first recombinant polyclonal antibody product to enter the clinic” commented Kirsten Drejer, Ph.D., Chief Executive Officer of Symphogen A/S. Biovitrum has been an excellent contract manufacturer for Symphogen in producing cGMP material for our first clinical trial for anti-RhD for the treatment of ITP and we look forward to continued progress of this exciting product in a true partnership with Biovitrum, Kirsten Drejer added. The Sym001 (anti-RhD) Program Symphogen’s lead product, Sym001, combines 25 different recombinant anti-Rhesus D (RhD) antibodies for the treatment of Idiopathic Thrombocytopenic Purpura (ITP) and the prevention of Hemolytic Disease of Newborns (HDN). The product holds promise to provide an improved safety profile and a more convenient treatment. ITP is a bleeding disorder caused by abnormally low platelet levels with an incidence in adults of 66 per one million per year. The market, which is estimated to be worth USD $500 million annually, worldwide, is influenced by a general shift in ITP treatment guidelines and a growing HIV population. HDN, known as the “blue baby syndrome”, occurs when RhD-negative women become sensitive to RhD through delivery of an RhD-positive child. In subsequent RhD+ pregnancies, this may trigger a maternal antibody response causing foetal red blood cell breakdown known as HDN. To prevent this, anti-RhD is administered to RhD- pregnant women, which constitute approximately 13-16 percent of all pregnant women in the US and Europe (a market value of USD $200 million per year). Symphogen Symphogen A/S is a biotechnology company pioneering therapeutic products based on recombinant natural human antibodies for the treatment and prevention of human disease. By use of its proprietary technologies Symphogen aims to develop and eventually market unique antibody-based products with an antibody composition that mimics the diversity, affinity, and specificity of the natural human immune system. Generation of antibody drug candidates is achieved using Symphogen’s proprietary SymplexTM technology. For development and manufacturing of polyclonal antibody drug candidates, designated symphobodies, the Company applies its proprietary expression platform, the SympressTM technology. Symphogen’s technologies offer best in class antibody therapeutics against both simple and complex target antigens. The commercial potential of symphobodies is expected to be very significant. For more information see www.symphogen.com Biovitrum Biovitrum is one of the larger biopharma companies in Europe. With operations in Sweden and in the UK Biovitrum conducts research and develops pharmaceuticals for both broad diseases and conditions that affect smaller patient populations. Biovitrum focuses on drugs for the treatment of obesity, diabetes, inflammation and blood diseases as well as a number of well defined niche indications. Biovitrum develops and produces protein-based drugs on a contractual basis and markets a range of specialist pharmaceuticals primarily in the Nordic countries. Biovitrum has approximately 500 employees. For more information see www.biovitrum.com/.

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Biovitrum is one of the larger biopharma companies in Europe. With operations in Sweden and in the UK Biovitrum conducts research and develops pharmaceuticals for unmet medical needs both for common diseases and conditions that affect smaller patient populations.Biovitrum focuses on drugs for the treatment of obesity, diabetes, inflammation and blood diseases as well as a number of well defined niche indications. Biovitrum develops and produces protein-based drugs on a contractual basis and markets a range of specialist pharmaceuticals primarily in the Nordic countries. Biovitrum has approximately 500 employees.

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