FDA Orphan Drug Designation gives Lung Therapeutics a seven-year US market exclusivity for LTI-01 in the treatment of empyema, typically a complication of pneumonia. LTI-01 is designed to reduce fibrinous scars in the lung cavity to allow fluid drainage without the need for surgery.
AUSTIN, TX — December 2, 2014 — Lung Therapeutics, Inc., a pharmaceutical company focused on niche, orphan drug indications in lung injury and disease, announced today the company has received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) for the company’s lead drug candidate, LTI-01, in the treatment of empyema, typically a complication of pneumonia.
Orphan drug designation is granted by the FDA to novel drugs or biologics that demonstrate value in the treatment of rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation will provide Lung Therapeutics with several benefits, including a seven-year period of U.S. marketing exclusivity.
Lung Therapeutics, Inc. CEO, Brian Windsor, Ph.D., said, “Achieving this important regulatory milestone so soon in our development phase further validates the need for our innovative technology. It also significantly strengthens Lung Therapeutics’ competitive position by providing several years of market exclusivity in the U.S. Our initial focus is on LTI-01, which is designed to treat empyema and complicated parapneumonic effusions, two complications of pneumonia that can involve fibrinous scarring that inhibits fluid drainage.”
LTI-01: Addressing Unmet Needs in Global Pharma Industry
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. LTI-01 therapeutic applications address unmet needs in a $300+ million global market.
Lung Therapeutics founder and Chief Scientific Officer, Steven Idell, M.D., Ph.D., said, “LTI-01 could improve outcomes for thousands of patients a year who become seriously ill with pleural effusions that are difficult to drain, and increasing incidence demands more effective therapy. We believe that LTI-01 will enable patients to avoid surgical treatment and its associated morbidity and cost.”
With prior grant funding to facilitate early development and pre-clinical work, the company currently has pipeline programs in three areas: LTI-01 for Pleural Effusion (PE) with Loculation, LTI-02 for Acute Lung Injury (ALI) and LTI-03 for Idiopathic Pulmonary Fibrosis (IPF).
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.
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