< 2004 News Listings Inotek Pharmaceuticals Announces Designation of INO-1001 as a Fast Track Product for Complications associated with Thoracoabdominal Aortic Aneurysm Surgery BEVERLY, MA May 24, 2004 Inotek Pharmaceuticals Corporation announced today that it has received notification from the Food and Drug Administration that one of its lead compounds, INO-1001, has been designated a Fast Track Drug Product for complications associated with Thoracoabdominal aortic aneurysm (TAAA) repair surgery. Phase II clinical trials are expected to begin at the beginning of the third quarter. INO-1001 is a potent inhibitor of the nuclear cell death enzyme Poly (ADP-ribose) Polymerase (PARP) and is being evaluated in Phase II trials for a variety of critical care diseases associated with reperfusion injury and inflammation, including ischemic stroke, acute respiratory distress syndrome, TAAA repair surgery and the prevention of complications associated with cardiopulmonary bypass surgery among others. Thoracoabdominal aortic aneurysm is a serious, life threatening disease caused by a dilation of the thoracic abdominal aorta which can lead to a rupture of the aorta. Mortality associated with TAAA repair surgery is approximately 10%. The most common complications associated with TAAA repair surgery are myocardial infarction, renal failure, pulmonary failure and paraplegia. "This is an extremely important milestone for Inotek" said Dr. Andrew Salzman, President and CEO of Inotek Pharmaceuticals. "We believe that INO-1001 will be an important drug for treating a number of very serious and life threatening diseases. Thoracoabdominal aortic aneurysm surgery is certainly a procedure where the need for improved therapies is great. We look forward to working with the FDA as we move forward with our clinical programs." Under the FDA Modernization Act of 1997, the Fast Track program is designed to facilitate the development and expedite review of the application for the approval of a new drug that is intended to treat serious or life-threatening conditions and that demonstrates the potential to address unmet medical needs. About Inotek Pharmaceuticals Corporation Inotek Pharmaceuticals is a research-based pharmaceutical company engaged in the discovery and development of novel, small-molecule therapeutics for the treatment of reperfusion injury, inflammation, and vascular dysfunction. The Company has developed a deep and diverse pipeline of products which are based on industry leading expertise in the area of vascular biology and free radical and oxidant mediated mechanisms of tissue injury, cellular necrosis, and inflammation. In 2004, the Company will have two drug products in Phase II of development, targeting a variety of important critical care conditions. Additionally, the Company has six (6) other products that are expected to enter human clinical trials in the next 6-12 months. Inotek's headquarters and research laboratories are located in Beverly, Massachusetts with overseas clinical and research operations in Israel and Hungary . Contact: Jeffrey T. Walsh Vice President, Corporate Development Inotek Pharmaceuticals Corporation (978) 232-9660 x388
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