By Michael Oneal | NeoPharm Inc. of Lake Bluff said it has filed an
orphan drug application with the U.S. Food and Drug Administration for
a its Idiopathic Pulmonary Fibrosis drug.

Orphan drug designation would prvide a a seven-year term of
market exclusivity for IPF upon final FDA approval. IPF is the most deadly disease of the lungs in humans with very high
morbidity. There is currently no
proven effective treatment for the cure of this lethal disease.

It is estimated that at least 55,000 patients are diagnosed
with IPF each year in America and about 45,000 patients die each year
with the disease, the company said in a release.

Dr. Aquilur Rahman, President and CEO, commented, “All the studies that NeoPharm has performed in animals and in ex vivo human tissue have shown that IL13-PE works as a targeted therapy for lung fibroblasts. IL13-PE exclusively binds to the pulmonary fibroblasts, which express IL13 receptors for selective cytotoxicity, thereby ameliorating all the clinical and histopathological evidence of IPF. We are looking forward to the start of our clinical studies in humans inflicted with this disease.”

The US Orphan Drug Act is intended to assist and encourage companies to
develop safe and effective therapies for the treatment of rare diseases
and disorders.