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FDA Grants Orphan Drug Designation To GeNO LLC For Use Of Inhaled Nitric Oxide In Treatment Of Persistant Pulmonary Hypertension Of The Newborn (PPHN)
Date:8/14/2012

WALTHAM, Mass., Aug. 14, 2012 /PRNewswire/ -- GeNO LLC (www.genollc.com), a privately held pharmaceutical  company developing a line of inhaled nitric oxide drug products, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for its nitric oxide (delivered via the GeNOsyl MVG-2000 delivery system) for the treatment of persistent pulmonary hypertension in newborns (PPHN).  The orphan drug designation was granted based on a plausible hypothesis for clinical superiority over the approved nitric oxide product.

Orphan Drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs to treat a rare disease or condition affecting fewer than 200,000 persons in the United States.  The designation provides the drug developer with a seven-year period of US marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax credits for clinical research costs, the ability to apply for grant funding, clinical research trial assistance and waiver of filing fees. 

"Our goal is to use our proprietary chemistry and delivery apparatus to provide low-dose inhaled NO that provides a level of purity that cannot be attained with currently available treatments," said GeNO President and Founder Dr. David Fine.  "We believe our technology has the potential to be a transformative therapy for patients suffering from rare diseases like PPHN for whom there are limited treatment options, and we are committed to advancing the clinical and commercial development of our nitric oxide delivery platforms because of the dramatic benefit they may have on the lives of patients.  Orphan Drug Designation of GeNO's drug produ
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SOURCE GeNO LLC
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