Discovery Labs is pushing back its launch plans for Surfaxin (lucinactant) to Q2 2006 due to additional information requested by FDA, the firm says Aug. 19. Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) for Prevention of Respiratory Distress Syndrome SURFAXIN is the First FDA-Approved Synthetic, Peptide-Containing Surfactant Discovery Laboratories, Inc. (Nasdaq: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today reports a commercial update To enable Verizon Media and our partners to process your personal data select 'I agree', or select 'Manage settings' for more information and to manage your choices. Surfaxin, a precision-engineered lung surfactant replacement therapy, has previously received orphan drug designation for the treatment of BPD, as well as fast track designation for both the prevention and treatment of BPD. WARRINGTON, Pa., Sept. 6, 2011 /PRNewswire/ -- Discovery Labs, Inc. today announced that, on September 2, 2011, it submitted its Complete Response to the 2009 Complete Response Letter issued by the... | December 27, 2020 Robert J. Capetola, Ph.D., President and Chief Executive Officer of Discovery commented, "Market exclusivity under this designation would mean that Surfaxin, as a precision-engineered surfactant, has the potential to become the dominant surfactant in the neonatal intensive care unit for the next decade. Discovery Laboratories, Inc. ( DSCO ) announced that the U.S. Food and Drug Administration (FDA) has approved product specifications update related. Discovery Labs, Inc. (Nasdaq: DSCO) today announced that, on September 2, 2011, it submitted its Complete Response to the 2009 Complete Response Letter issued by the U.S. Food and Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. We and our partners will store and/or access information on your device through the use of cookies and similar technologies, to display personalised ads and content, for ad and content measurement, audience insights and product development. Discovery recently concluded its Phase 2 double-blind, placebo-controlled trial early, enrolling approximately 130 very low birth weight premature infants born at risk for developing BPD. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant. Data obtained from tests are susceptible to varying interpretations, which may delay, limit or prevent regulatory approval. The Center for Breakthrough Medicines. About Discovery Labs Discovery Laboratories, Inc. is a biotechnology company developing surfactant therapies for respiratory diseases. Lease Space. Discovery Laboratories announced that the FDA has approved product specifications update related to Surfaxin. If the meeting is successful, Discovery Labs anticipates that Surfaxin may be approved in 2009. The Aerosurf delivery system is designed to integrate into the CPAP system to deliver aerosolized lucinactant (the active ingredient in Surfaxin® -lucinactant-) to babies receiving nasal CPAP. The purpose of the trial was to determine the safety and tolerability of administering Surfaxin as a therapeutic approach for the prevention and treatment of BPD. Did Crenshaw forget he jumped out of two planes last year? Zacks Equity Research , The intent of Discovery Labs was always to market Surfaxin in the United States, implying burdens on the Latin American children that outweighed the benefits. Discovery's proprietary SRT is also being developed in an aerosolized form under the name Aerosurf(tm), for the treatment of neonatal respiratory disorders. The drug, peptide-containing (KL4) surfactant was approved by the U.S. Food and Drug Administration (FDA) to treat RDS in premature babies. Discovery plans to report the top-line results in the fourth quarter of 2006. Discovery Labs conducted a Phase 2 clinical trial to evaluate the safety and potential efficacy of Surfaxin in infants at risk for BPD. These are the items every diehard fan will actually use and love! Shares of Discovery Laboratories jumped to 18-month highs Wednesday after federal regulators approved its respiratory distress syndrome treatment.THE SPARK: … Discovery Labs' Surfaxin(r) Phase 2 BPD Clinical Trial Results Published in Pediatrics Email Print Friendly Share 05 janv. WARRINGTON, Pa., June 15, 2006 (PRIMEZONE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to Discovery's lead product, Surfaxin(r), for the prevention of Bronchopulmonary Dysplasia (BPD, also known as Chronic Lung Disease) in premature infants. Some premature babies are born with a lack of natural surfactant in their lungs. The Discovery Labs is a Global Platform Company building large scale enterprise-level life sciences and technology companies and campuses designed to facilitate the expedition of cell and gene therapies from bench to bedside. Premature infants in this study received a treatment regime of up to 5 Surfaxin doses beginning within the first 3-10 days of life, in addition to the surfactant they received on day 1 of life for RDS. Orphan drug designation in the United States is awarded to compounds that offer potential therapeutic value in the treatment of rare diseases, defined as those affecting fewer than 200,000 Americans. Discovery Labs Surges on Surfaxin News. 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. This has created a dilemma that is created for the neonatologist and is the essence for why Discovery Labs is developing Aerosurf®. Discovery Laboratories, Inc. is a biotechnology company developing its proprietary surfactant technology as Surfactant Replacement Therapies (SRT) for respiratory diseases. Discovery Labs Announces Newly-Released SURFAXIN® Publications Warrington, PA - March 29, 2013- Discovery Laboratories, Inc. , a specialty biotechnology company dedicated... | January 10, 2021 Without surfactant, the air sacs in the lungs collapse and are unable to absorb sufficient oxygen resulting in Respiratory Distress Syndrome (RDS). 2009 08h30 HE | Source : Discovery Laboratories, Inc. To prevent and treat RDS, babies require a surfactant usually within the first hours of birth, and mechanical ventilation to support their respiration. FDA Chides Discovery Labs For Dissing Animal Products. Discovery Labs Surges on Surfaxin … Without surfactant, the air sacs in the lungs collapse and are unable to absorb sufficient oxygen resulting in RDS. Discovery Labs expects to learn Thursday, May 1, whether U.S. drug regulators will approve its lung surfactant Surfaxin as a treatment for premature infants suffering from respiratory distress. (PZ) Discovery Labs' Surfaxin Granted Orphan Drug Designation for the Prevention of Bronchopulmonary Dysplasia. Surfaxin, Discovery ’s lead drug, earned $19 million for Discovery . Discovery Laboratories, Inc. is a biotechnology company developing its proprietary surfactant technology as Surfactant Replacement Therapies (SRT) for respiratory diseases. Discovery recently completed and announced preliminary results of a Phase 2 clinical trial to address Acute Respiratory Distress Syndrome (ARDS) in adults, and is also developing aerosol formulations of SRT to potentially address Acute Lung Injury (ALI), cystic fibrosis and other respiratory conditions. You can change your choices at any time by visiting Your Privacy Controls. If the company complies with certain FDA specifications and should the drug receive marketing approval, orphan drug designation qualifies the sponsor for seven years of marketing exclusivity, exemption from the Prescription Drug User Fee Act filing fees, and tax credits related to clinical research. BPD is a costly syndrome affecting premature infants. A placebo was used and considered ethical by design since infants born in Latin America usually do not have access to life saving treatment. Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant. Rationale for Aerosurf. Information about your device and internet connection, including your IP address, Browsing and search activity while using Verizon Media websites and apps. If Surfaxin is the first product to receive marketing authorization in the United States for the treatment of Bronchopulmonary Dysplasia, orphan status would block any similar synthetic surfactant products for this indication throughout the United States market for a significant period of time.". For more information, please visit our corporate website at www.Discoverylabs.com. Surfaxin is an investigational drug product and is not approved by the FDA or any other world health regulatory authority for use in humans. Those associated risks and others are further described in Discovery's 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. In Discovery's Phase 2 clinical trial, 136 premature infants were enrolled and received either Surfaxin standard dose (175 mg/kg), Surfaxin low dose (90 mg/kg), or sham air as a control. Surfaxin was invented in the laboratories of Dr. Charles G. Cochrane at the Scripps Research Institute in La Jolla, Calif. Premature babies are born with a lack of natural surfactant in their lungs. 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Surfaxin is completely synthetic and thus avoids any potential risks associated with therapies derived from animal origin. Yahoo is part of Verizon Media. The favorite sparkling water of Texans is launching its first new flavor in four years. Discovery is preparing to conduct Phase 2 pilot studies with Aerosurf(tm), aerosolized SRT administered through nasal continuous positive airway pressure (nCPAP). Discovery believes that, through its technology, pulmonary surfactants have the potential, for the first time, to address respiratory diseases where there are few or no approved therapies available. The stock sinks after the company reveals it will not respond as swiftly as it thought to the FDA's concerns about Surfaxin. In September 2012, Discovery Laboratories started the four research projects to explore the KL4 surfactant technology for acute lung injury (ALI). These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Discovery’s Surfaxin is a synthetic, peptide-containing, precision-engineered surfactant that contains sinapultide, a novel 21-amino acid peptide designed to mimic the function of the critical human surfactant protein, SP-B. Discovery's lead product, Surfaxin(r), for the prevention of Respiratory Distress Syndrome (RDS) in premature infants, has received two Approvable Letters from the FDA. Discovery has been trying to win approval for Surfaxin since 2004. It is associated with surfactant deficiency and the prolonged use of mechanical ventilation and oxygen supplementation. By Jeff Overley. The lack of surfactant and use of mechanical ventilation may cause chronic injury and scarring of the lungs -- resulting in BPD. In addition, also for premature infants, Discovery recently concluded early a Phase 2 clinical trial of Surfaxin for the prevention and treatment of Bronchopulmonary Dysplasia (BPD), also known as Chronic Lung Disease. Discovery Labs Announces FDA Approval Of SURFAXIN(R) (Lucinactant) Updated Product Specifications Oct. 4, 2013 12:59 PM ET Commercial Introduction of SURFAXIN Planned for the Fourth Quarter of 2013 Discovery said it anticipates results from the mid-stage trial within the next month. Discovery (DSCO) è la più vicina, la data prevista per il responso di FDA per Surfaxin è il 6 marzo 2012, ... Mentre gli sforzi per far approvare Surfaxin procedevano, a Discovery Labs sono accadute altre due vicende. Discovery's Surfaxin has received two Approvable Letters from the FDA for the prevention of RDS in premature infants. Find out more about how we use your information in our Privacy Policy and Cookie Policy. Among the issues is a question regarding the stability test used by a supplier of one of Surfaxin's active ingredients. Discovery Labs licensed the right to … Discovery Labs had then planned to launch Surfaxin in late 2012. Discovery's technology produces a precision-engineered surfactant that is designed to closely mimic the essential properties of natural human lung surfactant. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials, even after obtaining promising earlier trial results. To the extent that statements in this press release are not strictly historical, including statements as to business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of Discovery's product development, events conditioned on stockholder or other approval, or otherwise as to future events, 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 projects are funded through government-sponsored, biodefense-related initiatives under the Project Bioshield Act of 2004 and the Pandemic and All Hazards Preparedness Act of 2006. Among the factors which could affect Discovery's actual results and could cause results to differ from those contained in these forward-looking statements are the risk that financial conditions may change, risks relating to the progress of Discovery's research and development, the risk that Discovery will not be able to raise additional capital or enter into additional collaboration agreements (including strategic alliances for aerosol and Surfactant Replacement Therapies), risk that Discovery will not be able to develop or otherwise provide for a successful sales and marketing organization in a timely manner, if at all, risk that approval by the FDA or other health regulatory authorities of any applications filed by Discovery may be withheld, delayed and/or limited by indications or other label limitations, risks that any such regulatory authority will not approve the marketing and sale of a drug product even after acceptance of an application filed by Discovery for any such drug product, risks that Discovery's CMC will not satisfy the FDA, risk in the FDA or other regulatory agency review process generally, risks relating to the ability of Discovery or Discovery's third party contract manufacturers and development partners to manufacture or provide Discovery with adequate supplies of drug substance, drug products and expertise for completion of any of Discovery's clinical studies, risks relating to drug manufacturing by Discovery, risks relating to the integration of manufacturing operations into Discovery's existing operations, other risks relating to the lack of adequate supplies of drug substance and drug product for completion of any of Discovery's clinical studies, risks relating to the ability of the Company and its collaborators to develop and successfully commercialize products that will combine our drug products with innovative aerosolization technologies, risks relating to the significant, time-consuming and costly research, development, pre-clinical studies, clinical testing and regulatory approval for any products that we may develop independently or in connection with our collaboration arrangements, and risks relating to the development of competing therapies and/or technologies by other companies. 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