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From the preliminary S-1: Prospectus summary This summary highlights selected information contained elsewhere in this prospectus. This summary does not contain all the information you should consider before investing in shares of our common stock. You should read this entire prospectus carefully, including "Risk factors" beginning on page 5 and our consolidated financial statements and the notes to those financial statements beginning on page F-1, before making an investment decision. Our business We are a biopharmaceutical company focused on the discovery, development, and commercialization of novel therapies to treat patients with diseases of the immune system. Our therapies are based upon a unique understanding of the way the immune system recognizes and avoids attacking the body's own tissues and proteins, as well as other antigens that are not harmful to the body. This state of non-aggressive responsiveness to an antigen is called immunological tolerance and is a natural part of a properly functioning immune system. Therapies that induce immunological tolerance represent a fundamentally new approach to treating and potentially curing autoimmune diseases, organ transplant rejection, and other conditions associated with adverse or undesirable immune responses. We have established a pipeline of five products, two in human clinical trials and three in preclinical development. Our most advanced products are: • TRX4 Our TRX4 monoclonal antibody is in an investigator-sponsored Phase II clinical trial of 80 patients in Europe with new-onset Type I diabetes. All of the patients have completed treatment and are currently in an 18-month follow-up phase. We plan to file an Investigational New Drug application for TRX4 with the U.S. Food and Drug Administration first for psoriasis and psoriatic arthritis by early 2004, and later for additional studies in new-onset Type I diabetes based on the results of the ongoing European trial; and • TRX1 Our TRX1 monoclonal antibody is being developed in collaboration with Genentech to induce tolerance in transplantation, autoimmune diseases, and clinical situations where the immune system attacks therapeutic proteins or biologic drugs. In July 2003, we completed a Phase I clinical trial in the United Kingdom, which demonstrated that TRX1 was generally well tolerated. We also have ongoing research and development programs focused on generating new monoclonal antibody and small molecule products for the treatment of immunological diseases. In addition, we have developed our TolerMab antibody technology, which is intended to enable us to modify antibodies to induce immunological tolerance to themselves. One of the limitations with current monoclonal antibody therapies is that they can trigger an immune system response which renders such therapies ineffective. We believe that our TolerMab technology will improve the side effect profile and enhance the long-term effectiveness of antibody therapy to treat patients with chronic disease. We are evaluating two TolerMab antibodies in preclinical development. Our strategy Our goal is to become the recognized leader in the discovery, development, and commercialization of products that treat patients with diseases of the immune system, such as Type I diabetes, psoriasis, psoriatic arthritis, multiple sclerosis, rheumatoid arthritis, transplant rejection, and immune system neutralization of therapeutic proteins. Our strategy to achieve this goal is to: • develop and commercialize our lead products to provide breakthrough therapies that induce immunological tolerance; • generate new products for our pipeline based on our understanding of T-regulatory cells; • leverage collaborative partnerships; • retain commercialization rights to certain products; • exploit knowledge of immunological tolerance to optimize clinical development; and • commercialize the TolerMab antibody technology internally and through partners. Collaboration with Genentech In December 2002, we entered into a collaboration agreement with Genentech for the development and commercialization of our TRX1 monoclonal antibody. To date, we have received an aggregate of $8.0 million from Genentech in the form of a license fee, an equity investment, and a milestone payment. We may receive up to approximately $80 million in additional payments if all development and regulatory approval milestones for TRX1 in multiple disease indications are achieved. If TRX1 receives marketing approval, we will be entitled to receive royalties on worldwide net sales. In addition, in lieu of receiving royalties on sales of TRX1 in the United States, we have the option to participate in a cost and profit sharing relationship with Genentech and to support the commercialization of TRX1 through our own medical science liaisons who would educate the medical profession about our product. For further information regarding our collaboration with Genentech, including any payments thereunder, see "Risk factors" on page 7 and "Business" on page 34. | ||||||||||||||
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