Discovery Labs About
Discovery Labs We are a biopharmaceutical company developing
our proprietary precision-engineered lung
surfactant technology as Surfactant Replacement
Therapies for respiratory diseases. 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. The absence or depletion of surfactants
is involved in a number of respiratory
diseases. Our surfactant technology is
a precision-engineered version of natural
human lung surfactant containing a peptide,
sinapultide, that is designed to precisely
mimic the essential human lung surfactant
protein B (SP-B). We believe that our
proprietary surfactant technology is the
only surfactant technology presently available
to potentially treat a broad range of
respiratory diseases including Respiratory
Distress Syndrome (often referred to as
RDS) in adults and infants, Bronchopulmonary
Dysplasia (often referred to as BPD, which
is a serious form of chronic lung disease),
asthma, Chronic Obstructive Pulmonary
Disease (often referred to as COPD, which
is a chronic condition of the lung that
prevents enough oxygen from reaching the
blood), Acute Lung Injury (often referred
to as ALI), and upper airway disorders
such as sinusitis (infection of the sinuses)
and sleep apnea. Surfaxin®, our lead product,
is being developed initially for critical
care patients with life-threatening respiratory
disorders where there are few, if any,
approved therapies. We completed two Phase
3 trials for Surfaxin for the prevention
of Respiratory Distress Syndrome in premature
infants. In April 2004, we filed a New
Drug Application (NDA) for this indication
and the FDA has accepted the NDA filing.
In October 2004, we have submitted a Marketing
Authorization Application (MAA) for this
indication with the EMEA which has been
validated for review. We are currently
in a Phase 2 clinical trial for Meconium
Aspiration Syndrome (MAS) in full-term
infants, a Phase 2 clinical trial for
Acute Respiratory Distress Syndrome (ARDS)
in adults, and a Phase 2 clinical trial
for the prevention of Bronchopulmonary
Dysplasia (BPD) in premature infants.
Product
Pipeline Discovery Labs Surfaxin® (lucinactant), our lead product,
is the first precision-engineered, protein
B-based agent that mimics the surface-active
properties of human surfactant. Surfaxin
has been shown to remove inflammatory
and infectious infiltrates from patients'
lungs when used by lavage, or "lung wash,"
and replenish the vital surfactant levels
in the lungs. Surfaxin is delivered in
a bolus form through an endotracheal tube
in premature infants, and as a proprietary
lavage through a tube, called a bronchoscope,
in full-term infants and adults. Surfaxin,
if approved, would be the world's next
generation surfactant—significantly improving
and expanding the current surfactant therapy
for RDS and treating other neonatal intensive
care unit (NICU) respiratory conditions
for which the only treatment today is
mechanical ventilation. The potential
attributes of Surfaxin create an opportunity
for improving critical care respiratory
medicine—a market that could exceed $1.5
billion. More
on Discovery
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