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INTRODUCTION Horizontal in-licensing Bio2Bio agreements IT-Bioinformatics Technology for genomics & proteomics Antibody technology Drug delivery and formulation process Horizontal out-licensing Bio2Bio agreements Genomics There is an increasing need for using newlly developed genomic tools in drug discovery and pharmacogenomics studies. For example, Lexicon is now having a broad access to Affymetrix's standard GeneChip arrays, instrumentation and software to monitor gene expression for use in their genetics and genomics research and development activities. The Affymetrix's GeneChip system consists of disposable DNA probe arrays containing gene sequences on a chip, and software to analyze and manage genetic information. This could lead to new cancer and inflammation therapeutics. Antibody technology An agreement between Celltech Group plc and Abgenix will provide Celltech with Abgenix's proprietary high throughput antibody selection technology to rapidly identify high affinity candidates from antibodies that have been generated by Celltech from human B-cells and ordinary mice. In addition, Biogen has agreed to use Abgenix's XenoMouse technology to generate fully human monoclonal antibodies to up to fifteen antigen targets for inflammatory CNS and neoplastic disorders supplied by Biogen during the collaboration's multi-year term. Towards gene and protein based therapeutics Horizontal co-development agreements Vertical licensing agreements Cancer Biotechnology companies, when developing antibody based therapeutics for inflammation and cancer are now looking for partners, who can provide new antigen targets and new antibody manufacturing technologies. Through an agreement with Abgenix, Inc. Celltech has been provided with extensive rights to use Abgenix's proprietary SLAM (Selected Lymphocyte Antibody Method) technology, for rapid selection in vitro of high affinity antibodies including the direct selection of fully human antibodies. This is the first licence by Abgenix of the technology platform it obtained when it acquired ImmGenics Inc., in December 2000. Abgenix's proprietary SLAM technology will provide Celltech with a rapid and efficient route to examine very large numbers of human antibody-generating cells, using rapid throughput methods, and to select single cells making antibodies with the desired, but rare, combination of very high affinity and appropriate functional activity. The genetic information will then copied to allow the manufacture of these antibodies as candidate therapeutic products. Other disorders Vertical co-development/marketing BIO2Bio agreements Cancer Cancer is a major therapeutic target for the biotechnology industry. A number of BIO2BIO partnerships have been constructed to develop new therpaeutic antibodies and other proteins against a series of neoplastic disorders. One of the most promising partnerships is between Genentech and OSI Pharmaceuticals. Clinical results were presented at the 37th Annual Meeting of the American Society of Clinical Oncology (ASCO), demonstrating the potential utility of Tarceva as a single agent treatment for patients with non-small cell lung and head and neck cancer. Tarceva is a small-molecule oral anti-EGFR (Epidermal Growth Factor Receptor) drug candidate which is being co-developed by Genentech and OSI Pharmaceuticals in phase II. British Biotech and ImmunoGen are now co-developing BB-10901 in phase I/II. The drug is a new antibody-based treatment derived from ImmunoGen's proprietary TAP technology. It was created by conjugating a powerful chemotherapeutic agent, the cytotoxic maytansinoid DM1, with the humanized monoclonal antibody, huN901, which binds to a particular protein found on the surface of SCLC cells. Inflammation Inflammatory disorders constitute the second major therapeutic target of all BIO2BIO co-developemnt agreements. XOMA and Genentech are co-developing Xanelim, an immunomodulatory anti-CD11a humanized monoclonal antibody, is designed to inhibit the binding of T-cells to other cell types and to target three key processes in the cascade of events that lead to psoriasis. In addition, Elan and Biogen are co-developing, Antegren (natalizumab), a humanized monoclonal antibody. The drug is one of the first in a new class of potential therapeutics known as alpha 4 integrin inhibitors that are designed to block immune cell adhesion to blood vessel walls and subsequent migration of lymphocytes into tissue. Antegren binds to the cell surface receptors known as alpha-4-beta 1 (VLA-4) and alpha-4-beta-7. Antegren may be useful in the treatment of a range of inflammatory and non-inflammatory diseases, including Crohn's Disease and multiple sclerosis. The humanized monoclonal antibody, demonstrated promising results on multiple endpoints in a phase II study of Crohn's Disease, a chronic inflammatory disease of the gastrointestinal tract, according to phase II data presented at the annual meeting of the American Gastroenterological Association during Digestive Disease. CNS disorders Developing innovative biotechnology products is a very risky business with failure more possible than success. Genzyme is co-developing with Diacrin one of the boldest CNS products NeuroCell-PD including the injection of fetal neural cells into the brain of Parkinson's patients. However, the product has not shown satisfatory phase II results and it appears that Genzyme and Diacrin may choose another indication or abandon the project. However, a promising alliance has been constructed between Oxford GlycoSciences (OGS) and Medarex to develop novel CNS therapeutics produced through the joint application of Medarex's fully human monoclonal antibody technology and OGS's proprietary proteomics technology for high-throughput protein analysis and target validation. Antibodies are increasingly being recognized as a rapid and efficient way to move potential products from the laboratory to the market. Medarex and OGS expect the first joint product from an OGS-discovered antigen to enter Medarex's T-12 development program in the near future and that the collaboration may generate multiple product candidates a year thereafter. Other disorders CONCLUSIONS