Pharmacia to respond to FDA with additional

Pharmacia to respond to FDA with additional Clinical Data in Support of Parecoxib Pharmacia Corporation today announced that it would be supplying additional data in response to a "not approvable" letter from the U.S. Food and Drug Administration (FDA) on the company's New Drug Application (NDA) file for the non-narcotic injectable analgesic, parecoxib sodium. The FDA letter indicated that there were deficiencies in the application. This letter was received today, the final day of the 10- month period set for the agency as a target timeframe for acting on NDA filings. Pharmacia filed an NDA for parecoxib last year seeking clearance for its use in the treatment of moderate-to-severe pain "We will continue to work with the FDA so that we may bring parecoxib to physicians and their patients as soon as possible," said G. Steven Geis, Ph.D, M.D., Group Vice President, Clinical Research, Arthritis and Pain and Cardiovascular. "We belive parecoxib will fill an unmet need for new options in pain management." Pharmacia anticipates that it will supplement the file in approximately 12-18 months. "There has been no advancement in injectable analgesics for the treatment of moderate-to-severe pain in more than a decade," said Jeffery Apfelbaum, M.D., Professor and Chairman, Clinical Affairs, Department of Anesthesia and Critical Care, the University of Chicago Hospitals. "There is a tremendous need for effective and safe injectable analgesics to address the undermanagement of pain.". Pharmacia does not believe that there will be a financial impact for 2001. The company reaffirms its previous guidance of 20 percent earnings- per-share (EPS) growth for 2001. Pharmacia Corporation (NYSE: PHA) is a top-tier global pharmaceutical company with a leading agricultural subsidiary. Pharmacia's innovative medicines and other products save lives and enhance health and wellness. Pharmacia's 59,000 people work together with many diverse stakeholders to bring these benefits to people around the world, and to create new health solutions for the future. Media Contact: Craig Buchholz, Pharmacia: +1 908 901 8896, mobile +1 908 432 2416, craig.w.buchholz@pharmacia Investor Contact: Craig Tooman, Pharmacia: +1 908 901 8853 ------------------------------------------------------------ This information was brought to you by Waymaker The following files are available for download: