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Z�� y <br /> Executive Summary <br /> Technology Platform + <br /> GalaGen is a unique biopharmaceutical company with a technology platform that enables rapid discovery <br /> and development of a broad range of milk-derived products for diseases of the human gastrointestinal <br /> tract. These products contain specific polyclonal antibodies,or immunoglobulins, that target individual <br /> pathogens and are processed from the milk and colostrum of dairy cows. The immunoglobulins are taken <br /> orally, either in a solid oral dosage form or as a dry powder reconstituted in liquid, and they act locally <br /> within the gastrointestinal tract to provide passive immunity, or immunity transferred from one individual <br /> to another. The products have potential utility for both treating and preventing infections. <br /> Product Portfolio <br /> GalaGen's products target complications of immunocom promised patients, including Cryptosporidium <br /> parvum-associated diarrhea and yeast infections of the mouth and esophagus caused by Candida albicans <br /> (thrush); ulcers and <br /> or caused by Helicobacter pylori; antibiotic-associated diarrhea caused by <br /> Clostridium difficile; and traveler's diarrhea caused by Shigella flexneri and enterotoxic E. coli. <br /> Benefits of Milk-derived Antibodies <br /> Because these antibody products are derived from milk, they are likely to be well tolerated, with minimal <br /> side effects. This safety profile should significantly reduce the regulatory burden, leading to faster and <br /> less expensive clinical development programs as compared to new chemical entities. In addition,the use <br /> of antibody products to treat gastrointestinal pathogens is expected to have certain key advantages over <br /> classical anti-infectives, including better specificity resulting in fewer side effects, less resistance due to <br /> the multiple mechanisms of attack these polyclonal antibodies possess, and applicability for a broader <br /> target group, including bacteria and their toxins, protozoa, viruses and fungi. <br /> Production System <br /> GalaGen immunizes pregnant cows, using in many cases proprietary immunization agents and regimens, <br /> collects and processes the colostrum, the antibody-rich milk obtained from the first six milkings after <br /> calving, using techniques that purify and preserve the activity of the antibodies. GalaGen's formal <br /> relationship with Land O'Lakes, the large midwestern dairy cooperative, provides access to colostrum <br /> from over 250,000 cows. This supply relationship takes advantage of the existing infrastructure of the <br /> cooperative members' Grade A dairy farms and the supply is expected to exceed the worldwide <br /> requirements for all the above mentioned products. <br /> Development Strategy <br /> GalaGen's strategy is first to demonstrate the safety and efficacy of these antibody products as therapeutic <br /> biopharmaceuticals, and later to exploit the technology's value for disease prevention. Because of the <br /> speed with which GalaGen can develop products, the low cost of manufacturing, and the safety of the <br /> products, GalaGen is demonstrating that it can bring a new therapeutic antibody product to market for a <br /> fraction of the cost of a traditional biopharmaceutical product. This makes it possible to develop products <br /> for small, orphan product indications as well as large markets. <br />