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http://www.guilfordpharm.com/ Neuroimmunophilin Ligands A new approach to neurological disorders Through a dedicated development program with one of the world's leading biotechnology companies, Guilford is pioneering a new approach to alter the course of serious neurological disorders. The Need: In the United States alone, more than five million people have been diagnosed with severe neurological disorders like Parkinson's and Alzheimer's disease. Despite the pervasiveness of these and other neurodegenerative illnesses, available therapies principally treat only the symptoms of these disorders, while offering little in the way of actual disease modification. Although nerve regeneration appears to be one of the most promising scientific advances on the horizon, there are no medicines yet available that can cause nerves to regrow after they have been damaged. The News: Guilford Pharmaceuticals is pioneering a new approach in the search for novel therapies to address serious neurological disorders. In collaboration with its corporate and academic partners, Guilford is developing a new class of drug candidates that have the potential to regenerate nerve cells damaged by disease and injury. These compounds, called neuroimmunophilin ligands, may offer hope for the millions of people afflicted by neurodegenerative disease, by potentially slowing down, stopping or reversing the course of their illness. Animal models suggest that neuroimmunophilin ligands may offer distinct advantages over other experimental nerve regeneration agents because they appear to target only damaged nerve cells (earlier compounds promoted regrowth of both normal and damaged nerves); can be administered orally; and, are capable of penetrating the blood-brain barrier without direct injection into the brain. The Background: Guilford is a pioneer in the rapidly emerging field of neurotrophic research, or the study of nerve regeneration. In 1990, scientists led by Dr. Solomon Snyder, Director, Department of Neuroscience at Johns Hopkins Medical School and a co-founder of Guilford, discovered that an immunosuppressive drug called FK-506 was able to induce nerve growth in both test tube and animal experiments. Using state-of-the-art drug design techniques, Guilford's scientific team synthesized a series of novel prototype drugs possessing the nerve regeneration characteristics of FK-506 without any undesired immune suppression effects. This was the starting point for what is one of Guilford's most promising technology platforms. The Development Strategy: Based on its growing body of knowledge and promising scientific research, Guilford partnered with Amgen, Inc., a leader in the biotechnology industry, to further advance its neuroimmunophilin program. In 1997, Guilford granted Amgen worldwide rights to develop, manufacture and market FKBP and certain other neuroimmunophilin ligands for up to 10 target indications, including Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke, peripheral neuropathies, and traumatic brain and spinal cord injuries. In exchange, Guilford received an initial payment of $35 million plus $13.5 million in research funding over a three year period commencing October 1997. The agreement provides for up to $392 million in additional milestone payments as well as royalties from any future product sales - based on successful development and regulatory approval of specific indications. The Status: Following experimentation with initial prototype compounds, Amgen and Guilford optimized a lead second-generation neuroimmunophilin ligand called NIL-A. Based on favorable preclinical results, Amgen has completed Phase I clinical testing and should commence Phase II clinical testing in Parkinson's patients in the second half of 2000. In addition, the partners are working collaboratively to develop other neuroimmunophilin compounds and are evaluating these compounds in a variety of preclinical models of neurodegenerative diseases. The Company: Guilford Pharmaceuticals (NASDAQ: GLFD) is dedicated to making a difference - to patients and shareholders - by making new medicines. Founded in 1993, its strategy is to rapidly develop innovative, novel therapies and drug delivery systems based on expertise in neuroscience and biopolymer drug development. Today, Guilford owns or has the rights to more than 200 U.S. and 600 foreign patents and patent applications. It has multiple product development opportunities, strong corporate partnerships, and total assets of $145 million (at December 31, 1999). For updated information, please contact Amgen Professional Services at 1-800-772-6436 or by fax 805-376-8550.