Discovery says FDA gives fast review for drug
Thu Jan 26, 2006 07:15 AM ET
CHICAGO, Jan 26 (Reuters) - Discovery Laboratories Inc.
(DSCO.O: Quote, Profile, Research) on Thursday said U.S. regulators granted a fast review of its experimental drug for chronic lung disease in premature babies.
The U.S. Food and Drug Administration granted so-called fast-track status for Surfaxin, the company's lead product, Discovery said. The expedited review is for hard-to-treat diseases with few treatments.
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FDA Grants Discovery Labs' Surfaxin Fast Track Designation for Prevention and Treatment of Bronchopulmonary Dysplasia
Thursday January 26, 7:00 am ET
WARRINGTON, Pa., Jan. 26, 2006 (PRIMEZONE) -- Discovery Laboratories, Inc. (NasdaqNM:DSCO - News) announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to Discovery's lead product, Surfaxin(r), for the prevention and treatment of Bronchopulmonary Dysplasia (BPD, also known as Chronic Lung Disease) in premature infants.
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Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug means that the FDA has determined that the drug is intended for the treatment of a serious or life-threatening condition that demonstrates the potential to address unmet medical needs for such a condition, and that the FDA will facilitate and expedite the development and review of the application for the approval of the product.
BPD is a costly syndrome affecting premature infants. It is associated with surfactant deficiency and the prolonged use of mechanical ventilation and oxygen supplementation. Some premature babies are born with a lack of natural surfactant in their lungs. Without surfactant, the air sacs in the lungs collapse and are unable to absorb sufficient oxygen resulting in Respiratory Distress Syndrome (RDS). To treat RDS, babies require a surfactant usually within one hour of birth as well as mechanical ventilation to support the babies' respiration. The lack of surfactant and use of mechanical ventilation may cause chronic injury and scarring of the lungs -- resulting in BPD.
Robert J. Capetola, Ph.D., President and Chief Executive Officer of Discovery commented, ``The FDA's decision to grant Fast Track designation to Surfaxin for BPD is important for the neonatal medical community. Presently there are no approved drugs for the treatment of BPD. These babies suffer from abnormal lung development and typically have a need for respiratory assistance spanning from many months to years. It is estimated that the cost of treating an infant with BPD in the United States can approach $250,000.''
Surfaxin has already received an Approvable Letter from the FDA for the prevention of RDS in premature infants and anticipates potential approval in April 2006. To further develop Surfaxin for neonatal respiratory diseases, Discovery is currently conducting a Phase 2 clinical trial to determine the safety and tolerability of administering Surfaxin as a therapeutic approach for the prevention and treatment of BPD. The BPD study design provides that premature infants receive a treatment regime of up to 5 Surfaxin doses beginning within the first 3-10 days of life that are in addition to the surfactant they received on day 1 of life for RDS. The purpose of this study is to determine whether such treatment can decrease the proportion of infants on mechanical ventilation or oxygen supplementation or decrease the incidence of death or BPD. Results from this trial are expected in 2006.
Surfactants are substances that are produced naturally in the lungs and are essential to the lungs' ability to absorb oxygen and to maintain proper airflow through the respiratory system. Surfactant treatment options available today are limited to FDA approved animal-derived or non-protein containing synthetic products and are only approved for RDS. Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant. In clinical trials comparing Surfaxin to the currently available products, Surfaxin demonstrated a significant survival advantage for RDS babies. If approved by the FDA, Surfaxin represents a potential alternative to the current surfactant treatment options for RDS.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing its proprietary surfactant technology as Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Lab's technology produces a precision-engineered surfactant that is designed to closely mimic the essential properties of natural human lung surfactant. Discovery Labs believes that through its technology, pulmonary surfactants have the potential, for the first time, to address respiratory diseases where there are few or no approved therapies available.
Discovery Labs' SRT pipeline is initially focused on the most significant respiratory conditions prevalent in the neonatal intensive care unit. The Company's lead product, Surfaxin(r), for the prevention of Respiratory Distress Syndrome (RDS) in premature infants, has received an Approvable Letter from the FDA and is under review for approval in Europe by the EMEA. Surfaxin is also being developed for the prevention and treatment of Bronchopulmonary Dysplasia (BPD, also known as Chronic Lung Disease) in premature infants. Discovery Labs is preparing to conduct multiple Phase 2 pilot studies with Aerosurf(tm), aerosolized SRT administered through nasal continuous positive airway pressure (nCPAP), for the treatment of neonatal respiratory failure.
To address the various respiratory conditions affecting pediatric, young adult and adult patients in the critical care and other hospital settings, Discovery Labs is conducting a Phase 2 clinical trial to address Acute Respiratory Distress Syndrome (ARDS) in adults, and is also developing aerosol formulations of SRT to address Acute Lung Injury (ALI), asthma, COPD, and other respiratory conditions.
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