| We
are a biotechnology company developing our proprietary
surfactant technology as Surfactant
Replacement Therapies (SRT) 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
technology produces a precision-engineered surfactant
that is designed to mimic the essential properties of
natural human lung surfactant. We
believe that through our technology, pulmonary surfactants
have the potential, for the first time, to address respiratory diseases
where there are few or no approved therapies available.
Our SRT pipeline is
initially focused on the most significant respiratory
conditions prevalent in the Neonatal Intensive Care Unit
(NICU).
Our
lead product, SurfaxinÒ
(lucinactant), for the prevention of Respiratory
Distress Syndrome (RDS) in premature infants, has
received an Approvable Letter from the U.S. Food and
Drug Administration (FDA). Surfaxin is also being developed for the
treatment of Bronchopulmonary Dysplasia (BPD, also known
as Chronic Lung Disease) in premature infants. In
addition, we are developing Aerosurf™, aerosolized SRT
administered through nasal continuous positive airway
pressure (nCPAP), to address neonatal respiratory failures.
Our SRT technology is
also being developed to address the various respiratory conditions
affecting pediatric, young adult and adult patients in the critical care
and other hospital settings. We have completed a Phase 2 clinical trial
to address Acute Respiratory Distress Syndrome (ARDS) in adults, and are
developing aerosol formulations of SRT to address Acute Lung Injury
(ALI), cystic fibrosis, and other
respiratory conditions.
We
are implementing a business strategy that includes: (i)
undertaking actions intended to gain regulatory
approvals for Surfaxin for RDS in premature infants;
(ii) investing in development of SRT pipeline programs,
including Aerosurf; (iii) continued investment in
manufacturing capabilities at the manufacturing
operations in New Jersey and, potentially, additional
facilities to be built or acquired by us for the
production of surfactant drug products; and (iv)
potentially entering into strategic partnerships for the
development and commercialization of our SRT product
candidates.
|
|