Discovery Labs anticipates commercial availability of its initial AFECTAIR device in December 2012. This initial device is intended for use in infants receiving ventilatory support in the neonatal and pediatric intensive care units (NICU, PICU). Because Discovery Labs expects that the same hospitals that purchase SURFAXIN are likely to purchase AFECTAIR, the Company's commercial and medical affairs organizations will be responsible for the commercial introduction of this product.
Conference Call and Webcast Details
Discovery Labs will hold a conference call and webcast today at
10:00 AM EDT
to discuss the foregoing. A live webcast of the conference call, including a slide presentation, is available at
. An archive of the webcast will be available on Discovery Labs' Investor Relations web site.
For "listen-only" participants and those who wish to take part in the question and answer portion of the call, the dial-in numbers are (866) 332-5218 (U.S.) or (706) 679-3237 (international). The passcode for the call is 55058190. A replay of the conference call will be available through
October 31, 2012
. The replay number is (855) 859-2056 or (404) 537-3406 using the same conference call passcode listed above. A replay will also be available at
SURFAXIN (lucinactant) intratracheal suspension is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN is the first and only peptide-containing, surfactant approved by the FDA and the only alternative to animal-derived surfactants.
SURFAXIN is intended for intratracheal use only. The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance. SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status. Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption. During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted the infant's clinical condition assessed and stabilized. SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS). For more information about SURFAXIN, please visit
. Information contained in, or accessible through, this website does not constitute a part of, and is not incorporated into, this press release.
AFECTAIR was developed initially as part of the AEROSURF
development program and is being developed as a series of proprietary disposable ventilator circuit/patient interface connectors that simplify the delivery of aerosolized medications to critical-care patients requiring ventilatory support. According to national health statistics and market assessment data, it is estimated that each year more than 1.3 million patients in
the United States
and European Union receive aerosolized medications while requiring ventilator support. Discovery Labs is implementing a business plan that potentially will allow for the commercial introduction of the initial AFECTAIR device in
the United States
in late 2012.
Readers are referred to, and encouraged to read in their entirety, the Form 8-K that Discovery Labs filed with the Securities and Exchange Commission (SEC) concurrently with the issuance of this press release, and Discovery Labs' Quarterly Report on Form 10-Q for the quarter ended
September 30, 2012
to be filed with the SEC, which includes further detail on the Company's business plans and operations, financial condition and results of operations.