WARRINGTON, Pa., May 20, 2014 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that it has strengthened its scientific leadership. Effective immediately, Steve Simonson, M.D., M.H.S. has joined the Company as Vice President, Clinical Development, and Lawrence Weinstein has joined as Vice President, Medical Device Development.
Dr. Simonson will oversee all aspects of clinical research, with responsibility for design and execution of clinical trials, and Mr. Weinstein will oversee all aspects of medical device research, design, and development. Their initial focus will be on the development of AEROSURF®, Discovery Labs' combination drug/device product, which is currently in phase 2 development to provide KL4 surfactant therapy through nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS) in premature infants. Both Dr. Simonson and Mr. Weinstein will report to Dr. Russell Clayton, Discovery Labs' Senior Vice President, Research and Development.
"Though the initial focus of both Steve and Larry will be on AEROSURF and premature infants born at risk for respiratory distress syndrome, our KL4 surfactant and drug delivery technology has the potential to address a significant number of additional diseases where surfactant deficiency is a problem," commented Dr. Clayton. "I believe that Steve and Larry will provide additional depth and scientific rigor to the excellent work already underway at Discovery. Their extensive experience in pulmonary medicine, neonatal drug development, and medical device development including capillary-based aerosolization technology will apply immediately to the AEROSURF program, and more broadly as we develop our respiratory critical care franchise."
Dr. Simonson brings over 25 years of medical practice and pharmaceutical industry clinical trial experience with a significant background in pulmonary critical care and developing respiratory drugs to the Discovery Labs team. Dr. Simonson spent 15 years at AstraZeneca Pharmaceuticals in areas of medical and clinical leadership primarily in the pulmonary and infection therapeutic areas. He has been involved in or led several successful IND and NDA filings including the Pulmicort® Turbuhaler® M3 NDA which was approved for treatment of asthma. He spent the next two years as Vice President of Clinical Development at Agennix, Inc., a biopharmaceutical company primarily focused in oncology and sepsis, leading programs including studies of talactoferrin in necrotizing enterocolitis, the second most common cause of morbidity in premature neonates. Most recently, Dr. Simonson was an Executive Director in the Molecule Development Group at Covance, a biopharmaceutical development services company, where he applied his experience to developing clinical programs for small and mid-size biotech and pharmaceutical companies. Dr. Simonson completed training in internal medicine followed by a fellowship in pulmonary and critical care medicine at Duke University Medical Center. He then held several faculty appointments at Duke in the departments of Anesthesiology and Medicine, including the divisions of Pulmonary and Critical Care Medicine. He is a Fellow of the American College of Chest Physicians, and author or co-author of multiple peer reviewed publications, abstracts, posters and chapters. Dr. Simonson received his medical degree from the Medical College of Wisconsin, and his Masters of Health Sciences degree in Biometry from the Duke University School of Medicine.
Mr. Weinstein brings to Discovery Labs 30 years of respiratory medical device experience, including direct experience with capillary-based technology. Mr. Weinstein spent nine years of his career with PARI Respiratory Equipment, a respiratory care company specializing in the delivery of aerosolized therapeutics. From 2001 to 2007, he was with PARI Innovative Manufacturers, leading manufacturing, quality, regulatory and engineering for North American operations including the successful launch of several respiratory products, culminating in his tenure as Vice President and Director of Product Technology. Mr. Weinstein also served both as President of Hydrate, Inc, where he worked in the field of capillary-based vaporization and led all aspects of development, manufacturing, marketing and sales, and Senior Vice President of Operations for PRE Holding. Previously, from 1997 to 2001, he served as Director of Technology for DHD Healthcare, a leading manufacturer of respiratory medical devices, and prior, worked in several roles of increasing responsibility within Cordis Corporation, a global interventional medical device company. Most recently, he served as President and Chief Operating Officer for ALR Technologies, a medical device company. He is the author or co-author of over 20 published articles, abstracts and posters in areas including aerosol drug delivery and respiratory humidification, and is a named inventor on over 20 US patents. Mr. Weinstein received his Master of Business Administration Degree and a Master of Science degree in Industrial Engineering from the University of Miami.
AEROSURF is a novel investigational combination drug-device product being developed to deliver Discovery Labs' synthetic, peptide-containing KL4 surfactant in aerosolized form though nasal continuous positive airway pressure (nCPAP) to premature infants with respiratory distress syndrome (RDS). AEROSURF could potentially allow for the administration of KL4 surfactant to premature infants without invasive endotracheal intubation, and may enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated. Discovery Labs has initiated a phase 2a clinical study to evaluate the safety and tolerability of aerosolized KL4 surfactant administered in escalating doses in premature infants 29 to 32 weeks gestational age who are receiving nCPAP for respiratory distress syndrome (RDS), compared to infants receiving nCPAP alone.
ABOUT DISCOVERY LABS
Discovery Laboratories, Inc. is a specialty biotechnology company focused on advancing a new standard in respiratory critical care. Discovery Labs' technology platform includes its novel proprietary KL4 surfactant, a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant, and its proprietary drug delivery technologies being developed to enable efficient delivery of aerosolized KL4 surfactant. Discovery Labs' strategy is initially focused on neonatology and improving the management of respiratory distress syndrome (RDS) in premature infants. Discovery Labs believes that its RDS product portfolio, including AEROSURF, if approved, has the potential to become the new standard of care for RDS and, over time, enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated.
For more information, please visit the Company's website at www.Discoverylabs.com.
To the extent that statements in this press release are not strictly historical, they 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 risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those affecting Discovery Labs' ability successfully to complete its development programs and realize the potential benefits of its RDS product portfolio, 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.