European Orphan Drug Designation gives Lung Therapeutics 10 years of market exclusivity in Europe for LTI-01 in the treatment of empyema, a complication of pneumonia.
AUSTIN, TX — January 13, 2015 — Lung Therapeutics, Inc., a pharmaceutical company focused on niche, orphan drug indications addressing unmet therapeutic needs in lung injury and disease, announced that the European Commission (EC) has granted the company’s lead drug candidate, LTI-01, orphan medicinal product designation for the treatment of empyema, a complication of pneumonia. The designation follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA).
LTI-01 is an injectable, fibronolytic drug that maximizes scar removal around the lungs, thereby promoting fluid drainage while minimizing bleeding risk and other complications. The drug is intended to replace costly surgery and ineffective off-label treatments, thus improving clinical outcomes and providing safer and more cost-effective therapeutic options for patients and healthcare providers worldwide.
Lung Therapeutics CEO, Brian Windsor, Ph.D., said, “We are pleased that the European Commission has recognized the potential of LTI-01 to improve patient outcomes in the treatment of empyema in Europe. This designation, along with the orphan drug status we have already received in the U.S. from the FDA, underscores the unmet medical need LTI-01 addresses for patients suffering from empyema.”
European orphan drug status confers up to 10 years of marketing exclusivity in all European Union (EU) member countries following marketing approval and a range of other benefits including EU-funded research, protocol assistance, and fee reductions. In the U.S., FDA orphan drug designation provides Lung Therapeutics with seven years of U.S. market exclusivity after marketing approval.
Andrew P. Mazar, Ph.D., Lung Therapeutics’ Co-Founder and Consulting Head of Product Development, said, “Having consulted on other EU orphan drug submissions in the past, I know how challenging the process can be. Accomplishing this important milestone is a significant achievement. In addition to 10 years of market exclusivity, EC orphan drug designation provides regulatory and financial incentives to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union, and where no satisfactory treatment has been available. We now have the potential to help patients around the world who previously had few if any viable options.”
About Lung Therapeutics, Inc.
Lung Therapeutics, Inc. is a pharmaceutical company formed to leverage 25 years of leading research in lung injury and disease by pursuing niche, orphan drug indications for which there is no current effective therapeutic option. Current pipeline programs include LTI-01 for Pleural Effusion (PE) with Loculation, LTI-02 for Acute Lung Injury (ALI) and LTI-03 for Idiopathic Pulmonary Fibrosis (IPF). Led by a core team experienced in pharmaceutical product development, Lung Therapeutics seeks to move LTI-01 into 2015 clinical trials. For more information on Lung Therapeutics, visit www.lungtx.com.
This press release contains forward-looking statements, including statements regarding the potential implications of the Company’s future development plans for LTI-01. These forward- looking statements contained herein represent the judgment of Lung Therapeutics as of the date of this release and actual results may differ materially from those anticipated as a result of various factors. Forward-looking statements speak only as of this press release date and the Company undertakes no obligation to update or revise these statements, except as may be required by law.
Nsight Public Relations