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Discovery Labs Presents New SURFAXIN and AFECTAIR Data at 2012 Hot Topics in Neonatology Annual Meeting

WARRINGTON, Pa., Nov. 28, 2012 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO) today announced it will present both SURFAXIN® and AFECTAIR® data at the 2012 Hot Topics in Neonatology Annual Meeting being held December 3-4 in Washington D.C.  Hot Topics in Neonatology is an internationally recognized medical meeting dedicated to advancing the practice of neonatology.

Earlier this year, SURFAXIN became the first Food and Drug Administration (FDA)-approved synthetic, peptide-containing surfactant for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk of developing RDS.  Also, in February 2012, the company's AFECTAIR device was registered with the FDA and cleared for marketing in the United States.  AFECTAIR is a proprietary disposable airway connector that simplifies the delivery of aerosolized medications to critical-care patients requiring ventilatory support from either intermittent mechanical ventilation or continuous positive airway pressure.

Discovery Labs presentations at Hot Topics in Neonatology include:

Pharmacoeconomic Impact of Bronchopulmonary Dysplasia in Reintubated Infants – Simmons PD and Clayton RG
In Vitro Comparison of Albuterol Delivery Using a Novel Neonatal Ventilator Circuit Connector with Three Different Neonatal Ventilators  – Gregory TJ, Henderson C, Mazela J, Boppana V, and Clayton RG

Additionally, a late-breaker platform presentation entitled New insights into effective aerosol therapy in premature infants - Are we ready to inhale surfactants? will provide a comprehensive review of aerosolized treatment options for RDS today and into the future.  This topic, which is relevant to Discovery Labs' aerosolized KL4 surfactant development candidate, AEROSURF®, will be presented at 11:45am on December 4 th.

For over 30 years, Hot Topics has been the premier neonatal conference, with more than 1,000 neonatologists and perinatologists attending each year.  For more information about Discovery Labs and its products, attendees can visit Discovery Labs in the Hot Topics in Neonatology Internet Café or visit www.discoverylabs.com

IMPORTANT SAFETY INFORMATION
SURFAXIN (lucinactant) Intratracheal Suspension 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 and 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 or AFECTAIR, please visit www.surfaxin.com  or www.afectair.com, respectively.


ABOUT DISCOVERY LABS
Discovery Laboratories, Inc. is a specialty biotechnology company with one focus – to advance a new standard in respiratory critical care.  Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, lyophilized, and aerosolized dosage forms. Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies.  Discovery Labs believes that its proprietary technologies make it possible, for the first time, to develop a significant pipeline of products to address a variety of respiratory diseases for which there frequently are few or no approved therapies.  For more information, please visit our website at www.Discoverylabs.com.


Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those related to the potential pharmacoeconomic benefits of SURFAXIN, the utility of the AFECTAIR device for infants, and Discovery Labs' products under development, including AEROSURF, are described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Any forward-looking statement in this release speaks only as of the date on which it is made.  Discovery Labs assumes no obligation to update or revise any forward-looking statements.


 

SOURCE Discovery Laboratories, Inc.

 
CONTACT: Media Relations, Michael Parks, Pitch360, +1-484-356-7105, Michael@pitch360inc.com or Investor Relations, Michael Rice, LifeSci Advisors, +1-646-597-6979, mrice@lifesciadvisors.com or John G. Cooper, President and Chief Financial Officer, +1-215-488-9490

Web Site: http://www.discoverylabs.com

WARRINGTON, Pa., Nov. 28, 2012 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO) today announced it will present both SURFAXIN® and AFECTAIR® data at the 2012 Hot Topics in Neonatology Annual Meeting being held December 3-4 in Washington D.C.  Hot Topics in Neonatology is an internationally recognized medical meeting dedicated to advancing the practice of neonatology.

Earlier this year, SURFAXIN became the first Food and Drug Administration (FDA)-approved synthetic, peptide-containing surfactant for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk of developing RDS.  Also, in February 2012, the company's AFECTAIR device was registered with the FDA and cleared for marketing in the United States.  AFECTAIR is a proprietary disposable airway connector that simplifies the delivery of aerosolized medications to critical-care patients requiring ventilatory support from either intermittent mechanical ventilation or continuous positive airway pressure.

Discovery Labs presentations at Hot Topics in Neonatology include:

Pharmacoeconomic Impact of Bronchopulmonary Dysplasia in Reintubated Infants – Simmons PD and Clayton RG
In Vitro Comparison of Albuterol Delivery Using a Novel Neonatal Ventilator Circuit Connector with Three Different Neonatal Ventilators  – Gregory TJ, Henderson C, Mazela J, Boppana V, and Clayton RG

Additionally, a late-breaker platform presentation entitled New insights into effective aerosol therapy in premature infants - Are we ready to inhale surfactants? will provide a comprehensive review of aerosolized treatment options for RDS today and into the future.  This topic, which is relevant to Discovery Labs' aerosolized KL4 surfactant development candidate, AEROSURF®, will be presented at 11:45am on December 4 th.

For over 30 years, Hot Topics has been the premier neonatal conference, with more than 1,000 neonatologists and perinatologists attending each year.  For more information about Discovery Labs and its products, attendees can visit Discovery Labs in the Hot Topics in Neonatology Internet Café or visit www.discoverylabs.com

IMPORTANT SAFETY INFORMATION
SURFAXIN (lucinactant) Intratracheal Suspension 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 and 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 or AFECTAIR, please visit www.surfaxin.com  or www.afectair.com, respectively.


ABOUT DISCOVERY LABS
Discovery Laboratories, Inc. is a specialty biotechnology company with one focus – to advance a new standard in respiratory critical care.  Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, lyophilized, and aerosolized dosage forms. Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies.  Discovery Labs believes that its proprietary technologies make it possible, for the first time, to develop a significant pipeline of products to address a variety of respiratory diseases for which there frequently are few or no approved therapies.  For more information, please visit our website at www.Discoverylabs.com.


Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those related to the potential pharmacoeconomic benefits of SURFAXIN, the utility of the AFECTAIR device for infants, and Discovery Labs' products under development, including AEROSURF, are described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Any forward-looking statement in this release speaks only as of the date on which it is made.  Discovery Labs assumes no obligation to update or revise any forward-looking statements.


 

SOURCE Discovery Laboratories, Inc.

 
CONTACT: Media Relations, Michael Parks, Pitch360, +1-484-356-7105, Michael@pitch360inc.com or Investor Relations, Michael Rice, LifeSci Advisors, +1-646-597-6979, mrice@lifesciadvisors.com or John G. Cooper, President and Chief Financial Officer, +1-215-488-9490

Web Site: http://www.discoverylabs.com

 

Posted: November 2012

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