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FDA Accepts GeNO LLC Filing of New Drug Application for GeNOsyl™ MVG-2000 Nitric Oxide Delivery System


11/13/2012 10:20:54 AM

WALTHAM, Mass., Nov. 13 , 2012 /PRNewswire/ -- GeNO LLC (www.genollc.com) today announced that its New Drug Application (NDA) for GeNOsyl MVG-2000 Nitric Oxide Delivery System for neonates with hypoxic respiratory failure, which was filed on August 31, 2012, has been accepted for filing by the U.S. Food and Drug Administration (FDA).

"We are pleased with the FDA's acceptance of our NDA submission for review as it is a significant achievement in the regulatory approval process," said David Fine, GeNO President and Founder. "The FDA's acceptance for filing of this NDA follows 510(k) clearance earlier this year of GeNO's MV-1000 inhaled nitric oxide delivery system, and orphan drug designation of GeNOsyl (nitric oxide delivered via the MVG-2000 delivery system). We believe that GeNO's novel nitric oxide delivery systems have the potential to transform the treatment of pulmonary hypertension, and other conditions, by delivering a more pure form of nitric oxide for inhalation that contains lower levels of nitrogen dioxide and are less costly."

GeNOsyl nitric oxide for inhalation is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.

GeNO is developing three unique nitric oxide delivery platforms: a stand-alone gas cylinder system for hospital and outpatient use, a ventilator-based platform for Intensive Care Unit use, and a pocket-sized ambulatory system for chronic outpatient use. Each of the platforms are designed to deliver extremely low levels of nitrogen dioxide, an impurity that is undetectable by conventional means, while also addressing the cost, complexity and lack of portability of currently approved inhaled nitric oxide treatment systems. GeNO'snitric oxide gas has the potential for use in the treatment of a multitude of serious pulmonary and cardiac diseases, and potentially could reach a much larger group of patients than the currently approved alternatives.

GeNO has completed a Phase 2 pilot study of its nitric oxide for use as a diagnostic in Pulmonary Arterial Hypertension (PAH) and is currently performing a dose-escalation trial for the treatment of Pulmonary Hypertension in patients with PAH and Pulmonary Hypertension secondary to Idiopathic Pulmonary Fibrosis (PH-IPF). Additional study details can be found on http://clinicaltrials.gov/-- ClinicalTrials.gov Identifier NCT01265888. Other than the 510(k) clearance of GeNO's MV-1000 nitric oxide delivery system, GeNO's nitric oxide delivery technologies are investigational and are not approved by regulatory authorities.

ABOUT GENO LLC                                          
GeNO LLC, founded in 2006, is a privately held pharmaceutical company that is developing innovative nitric oxide (NO) generation and delivery platforms to enable the true potential of inhaled nitric oxide to be realized for the treatment of a multitude of diseases. The company is focused on applying its technology to delivering inhaled NO to patients in a variety of settings, including ambulatory and in-home use for potential chronic treatment. GeNO will provide stand-alone medical devices and combination products that include delivery systems and GeNO's nitric oxide gas. GeNO's nitric oxide delivery systems have been designated as Combination Products by the FDA Office of Combination Products, with the Division of Cardiovascular and Renal Products designated as the lead reviewer. The combination products will be regulated by the FDA as new drugs with their own NDAs.

Media Contacts:


Kellie Caldwell, 610-505-1511

Brian Heffron, 781-799-9568

kelliemcaldwell@gmail.com

bheffron@ctpboston.com

www.genollc.com

www.genollc.com

SOURCE GeNO LLC



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