GOVERNMENT

PALO ALTO, CA -- Roche Bioscience and Pharsight Corp. (Nasdaq:PHST) today announced that the two companies have entered into an agreement to collaborate on linking Roche's "Digital Disease" genomics discovery platform to clinical drug development through application of Pharsight's modeling and simulation expertise and software tools. The agreement will allow Roche to explore the influence of genetic analysis on the design of clinical trials and drug development programs. Ultimately, the results of this work should help researchers devise strategies that enable treatments to be more precisely tailored to a patient's unique physiology. Under terms of the agreement, Pharsight will provide consulting services to develop models that relate drug treatment to clinical outcome, based on identified genetic difference characteristics in the human population. The initial modeling and simulation will use information from Roche's mouse "Digital Disease" genomics discovery platform (Science. 2001 292:1814-5) to identify the genetics traits influencing drug efficacy. These models will be used to simulate clinical trials, based on the Pharsight Trial Simulator(TM) software, to explore alternative trial design and to assess how to best incorporate genetic analysis into the trial design. Roche will identify and test the optimal design to validate the use of Pharsight's modeling and simulation methodology, linking genetic analysis with clinical drug development. The financial terms of the agreement were not disclosed. "Much of the emphasis in genomic research has been directed toward identification of new targets for drug discovery; however, genomics can improve the efficiency of the entire drug development process, from discovery through clinical development," said Gary Peltz, M.D., Ph.D., head of genetics for the Roche Bioscience Inflammatory and Viral Diseases Unit. "Genomic research has not been widely utilized in many areas of clinical development in the pharmaceutical industry. In our collaboration with Pharsight, we expect to better understand how to link a genomics discovery platform to the clinical development of new drugs. Pharsight has the right combination of scientific expertise and simulation tools to help us explore this complex problem. This is one step toward the development of individualized healthcare from which patients will benefit by receiving treatment tailored to their specific physiology." "Modeling and simulation is the logical bridge between the huge contributions of genomics in drug discovery and clinical drug development," said Greg Lee, Ph.D., Pharsight founder and vice president of engineering. "What is particularly exciting about the Roche collaboration is that it leverages Roche's `Digital Disease' platform, and that it involves a prospective validation of the application to clinical development. We expect to have a quantitative demonstration of the general benefits of exploiting genetic knowledge in clinical trials. If the technology is successful at optimizing clinical trial design, then the same principles should apply to optimizing drug treatment for patients. This is the most exciting part of the collaboration: the potential for improving drug therapy by selecting the right drug, and giving it at the right dose, for the individual patient." For further information visit www.pharsight.com or http://paloalto.roche.com