NeoPharm, Inc. (Other OTC: NEOL.PK), announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan-drug designation for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Dr. Aquilur Rahman, President and CEO, commented, "IPF is the most deadly disease of the lungs in humans with very high morbidity. It is estimated that about 55,000 patients are diagnosed with the disease and almost 45,000 of them die with this disease every year in the U.S. There is currently no proven effective treatment to cure this disease. All the studies that NeoPharm has performed in animals and in ex vivo human tissue have shown quite promising results. We look forward to starting our clinical studies with IL13-PE as aerosolized product in humans inflicted with this devastating disease quite soon."
Orphan Drug designation provides a seven-year term of market exclusivity for IPF upon final FDA approval. Orphan Drug designation positions NeoPharm to take advantage of a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees and certain tax credits.