Press Release: Neose Receives FDA Clearance to Commence U.S. Clinical Trials for NE-180
Neose Receives FDA Clearance to Commence U.S. Clinical Trials for NE-180 HORSHAM, Pa. -- Neose Technologies, Inc. today announced that it has received clearance from the United States Food and Drug Administration (FDA) to commence clinical trials for NE-180 in the United States. NE-180 is a long-acting, GlycoPEGylated erythropoietin (EPO) being developed for the treatment of anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy and for the treatment of anemia associated with chronic kidney disease, including patients on dialysis and patients not on dialysis. NE-180 is currently in a Phase II trial for oncology-related anemia in Switzerland. â€œWe are pleased to come off clinical hold with the FDA. This clearance provides us the opportunity to include the United States in our global drug development program for NE-180,â€ said George J. Vergis, Ph.D., Neose president and chief executive officer. About Neose Technologies, Inc. Neose Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development of next-generation therapeutic proteins that are competitive with best-in-class protein drugs currently on the market. The lead candidates in its pipeline, NE-180 for use in the treatment of chemotherapy-induced anemia and anemia associated with chronic renal failure and GlycoPEG-GCSF for chemotherapy-induced neutropenia, target markets with aggregate sales in excess of $15 billion. For more information, please visit http://www.neose.com. Neose â€œSafe Harborâ€ Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are â€œforward-looking statementsâ€ that involve risks and uncertainties, including without limitation the risk that NE-180 fails in clinical trials, the risk that we will never receive regulatory approval of NE-180 and the risk that we will be unable to successfully commercialize or market NE-180. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statement, see the section of Neoseâ€™s Annual Report on Form 10-K for the year ended December 31, 2005, entitled â€œFactors Affecting the Companyâ€™s Prospectsâ€ and discussions of potential risks and uncertainties in Neoseâ€™s subsequent filings with the SEC.