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.
About AEROSURF®
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.
Forward-Looking Statements
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.