Orphan drug designation granted to Discovery Laboratories' KL4 surfactant Print E-mail
By Staff and Wire Reports   
Monday, 01 November 2010 06:06

Discovery Laboratories, Inc. (Nasdaq:DSCO), a biotechnology company developing therapies for respiratory diseases today announced that the Office of Orphan Products Development of the FDA has granted orphan drug designation to their KL4 surfactant for the treatment of cystic fibrosis (CF)- a fatal genetic disease that causes life-threatening lung infections and premature death. It affects approximately 30,000 patients in the United States and nearly 70,000 worldwide.

The Company’s shares trade KL4 technology produces a synthetic peptide that is structurally similar to pulmonary surfactant, a substance produced naturally in the lung and essential for survival and normal respiratory function. The stock is trading near it's 52-week lows. It saw highs near the $1 level during the past 52 weeks.

Dr. Thomas F. Miller, Discovery Labs' Chief Operating Officer commented, "To date, Discovery Labs has successfully procured orphan designations for several respiratory disease targets in both the U.S. and Europe. We are pleased that the FDA's Office of Orphan Products Development has granted orphan designation for KL4 surfactant for CF treatment."

Dr. Miller continued, "Previous preclinical and exploratory clinical studies suggest that surfactant may improve mucociliary clearance, thereby potentially preventing further compromise of lung function. Our preclinical and recent clinical experience suggests that CF may be a viable therapeutic target for our aerosolized KL4 surfactant technology."

CF is caused by a genetic mutation that leads to the production of thick, viscous mucus that is difficult to clear from the airways of the lung. The abnormal mucus allows for chronic airway infections that lead to airway destruction, decreased lung function, and ultimately, death.

Orphan designation provides for up to seven years of U.S. market drug product exclusivity for the designated indication following marketing authorization.

Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies.

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