SurfaxinTreatment for Respiratory Distress Syndrome
Update: Surfaxin (lucinactant) Now FDA Approved - March 6, 2012
FDA Establishes Target Action Date for Potential Approval of Surfaxin
FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin
WARRINGTON, Pa., Nov. 7, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Discovery Labs' Complete Response for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The FDA has designated the Complete Response as a Class 2 resubmission and has established April 17, 2009 as its target action date under the Prescription Drug User Fee Act (PDUFA) to complete its review and potentially grant marketing approval for Surfaxin.
Discovery Labs will host a conference call on Monday, November 10th at 9:00 AM EST. The call-in number is 866-332-5218.
The Complete Response addressed all of the remaining requirements contained in the May 2008 Approvable Letter that must be satisfied to gain U.S. marketing approval for Surfaxin. Discovery Labs provided the FDA specific data, information and minor clarifying analyses and believes that its Complete Response supports the approval of Surfaxin.
The May 2008 Approvable Letter did not require any additional clinical trials. Prior to receiving the Approvable Letter, Discovery Labs made notable progress towards gaining FDA approval of Surfaxin, including agreeing with the FDA on the content of the Surfaxin package insert and successfully concluding a pre-approval inspection of Discovery Labs' manufacturing operations.
Surfaxin represents the first peptide-containing, synthetic surfactant potentially available for addressing RDS. RDS is a condition in which premature infants are born with an insufficient amount of their own natural surfactant, a substance produced naturally in the lungs and essential for breathing. This condition often requires that infants receive surfactant replacement therapy (currently animal-derived surfactants) along with mechanical ventilation to survive. More than 500,000 infants born each year are at risk for developing RDS in the developed world. In the United States, RDS afflicts approximately 120,000 premature infants annually, of which approximately 80,000 of those infants are treated with the currently-available surfactants.
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' technology produces a peptide-containing synthetic surfactant that is structurally similar to pulmonary surfactant. Discovery Labs believes that, with its proprietary technology, SRT has the potential, for the first time, to address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.
Discovery Labs' lead product from its SRT pipeline is SURFAXIN for the prevention of Respiratory Distress Syndrome in premature infants. The U.S. FDA has established April 17, 2009 as its target date to complete its review of this new drug application (NDA) and potentially grant marketing approval for this product. SURFAXIN is also being developed for other neonatal and pediatric indications. AEROSURF(tm), Discovery Labs' aerosolized SRT, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine. For more information, please visit our website at www.Discoverylabs.com.
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, including, without limitation, the risks that: Discovery Labs' response to the recent Approvable Letter for Surfaxin may not satisfy the FDA; the FDA or other regulatory authorities may not accept, or may withhold or delay consideration of, any applications that Discovery Labs may file for its products, or may not approve any such applications or may limit marketing of such products to particular indications or impose unanticipated label limitations; changes in the national or international political and regulatory environment may make it more difficult for Discovery Labs to gain FDA or other regulatory approval of its products; Discovery Labs may be unable to raise additional capital or enter into additional collaboration agreements (including strategic alliances for development or commercialization of SRT); Discovery Labs' lengthy and costly research and development programs, including pre-clinical studies, clinical trials and other efforts to gain regulatory approval for any of its products, including Surfaxin, may not progress or may be subject to potentially significant delays or regulatory holds, or fail; Discovery Labs or its contract manufacturers or materials suppliers may be unable to successfully manufacture adequate supplies of its drug product or drug substances when needed or in amounts sufficient to meet demand; Discovery Labs may be unable to develop, manufacture and successfully commercialize products that combine Discovery Labs' drug products with innovative aerosolization technologies; Discovery Labs may be unable to profitably develop and market its products; Discovery Labs may be unable to maintain and protect the patents and licenses related to its SRT technology; other companies may develop competing therapies and/or technologies or health care reform may adversely affect Discovery Labs; and Discovery Labs may become involved in securities, product liability and other litigation. The foregoing risks and others are further 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.
-0- CONTACT: Discovery Laboratories, Inc. Investor Relations Lisa Caperelli 215-488-9413
Posted: November 2008
- Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome - March 6, 2012
- Discovery Labs Notified of PDUFA Date for Surfaxin - October 12, 2011
- Discovery Labs Submits Surfaxin Complete Response to FDA - September 6, 2011
- Discovery Labs Provides Expanded Update Regarding Its Program for Surfaxin U.S. Marketing Authorization - February 1, 2011
- Discovery Labs Provides Update Regarding Its Program for Surfaxin U.S. Marketing Authorization - January 10, 2011
- Discovery Labs Receives FDA Guidance Regarding Preclinical Program to Gain Surfaxin Approval - June 8, 2010
- Discovery Labs Achieves Key Milestone Towards Potential Surfaxin Approval - May 19, 2010
- Discovery Labs and FDA Establish Path for Potential Surfaxin Approval - October 2, 2009
- Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for Surfaxin Approval - September 11, 2009
- Discovery Labs Reports On Surfaxin End of Review Meeting With FDA - July 2, 2009
- Discovery Labs and FDA to Meet On June 2, 2009 to Discuss Surfaxin Complete Response Letter - May 12, 2009
- Discovery Labs Submits Complete Response to May 2008 FDA Approvable Letter for Surfaxin for RDS - October 20, 2008
- Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin - September 24, 2008
- Discovery Labs Reports Progress in Responding to Surfaxin FDA Approvable Letter - August 6, 2008
- Discovery Labs and FDA Meet to Clarify Limited Items in Surfaxin Approvable Letter - June 19, 2008
- Discovery Labs and FDA to Meet On June 18, 2008 to Clarify Limited Items in Surfaxin Approvable Letter - May 29, 2008
- Discovery Labs Provides Guidance On FDA Approvable Letter for Surfaxin for RDS - May 5, 2008
- Discovery Labs Receives An Approvable Letter From FDA for Surfaxin for RDS - May 2, 2008
- Discovery Labs' Response to Surfaxin Approvable Letter Deemed Complete by FDA - November 16, 2007
- Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - November 1, 2007
- Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter - October 1, 2007
- Discovery Labs Provides Update On Progress for Surfaxin for RDS - August 2, 2007
- Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval - January 22, 2007
- Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters - September 28, 2006
- Discovery Labs Receives Second Approvable Letter From FDA for Surfaxin for RDS - April 5, 2006
- FDA Accepts Discovery Labs' Complete Response to Approvable Letter for Surfaxin - October 21, 2005
- Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin - August 19, 2005
- Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin - August 15, 2005
- Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - July 29, 2005
- Discovery Labs Receives Approvable Letter from FDA for Surfaxin for Respiratory Distress Syndrome in Premature Infants - February 14, 2005
- Discovery Laboratories Announces FDA Acceptance of Surfaxin New Drug Application - June 15, 2004
- Discovery Laboratories Files New Drug Application with the FDA to Market Surfaxin for the Prevention of Respiratory Distress Syndrome in Premature Infants - April 14, 2004