WARRINGTON, Pa., Feb. 1, 2016 /PRNewswire/ -- Discovery
Laboratories, Inc. (NASDAQ: DSCO), a biotechnology company focused
on developing aerosolized KL4 surfactant therapies for respiratory
diseases, today announced the appointment of a new Chief Executive
Officer and has provided an update on its AEROSURF phase 2
program.
New President and Chief Executive Officer
Craig Fraser has been appointed
as the Company's President and Chief Executive Officer, effective
immediately. Mr. Fraser has also been elected to the
Company's board of directors. Mr. Fraser succeeds
John G. Cooper who is leaving the
Company to pursue other interests.
"Craig is a proven leader with deep commercial, operational,
business and drug development experience," commented John R. Leone, Chairman of the Board of
Discovery Labs. "With strong leadership skills, success as a Chief
Operating Officer for a publicly held biotechnology company and an
impressive track record of driving performance, we believe that
Craig is the right person to lead Discovery Labs and capitalize on
the tremendous opportunity that exists with the Company's KL4
surfactant and aerosol delivery technologies to address a range of
respiratory diseases beginning with AEROSURF for premature infants
with respiratory distress syndrome."
Mr. Fraser brings to Discovery Labs over 25 years of progressive
leadership experience, as well as expertise in advancing pipeline
products and building global brands and businesses. Prior to
joining Discovery Labs, Mr. Fraser held a number of leadership
positions at several biotechnology and pharmaceutical companies,
most recently as Chief Operating Officer at Aegerion
Pharmaceuticals, Inc. At Aegerion, Mr. Fraser had worldwide
responsibility for commercial operations, manufacturing and supply
chain, as well as corporate initiatives, including strategic
development for growth and sustainability. Mr. Fraser has
also held senior management positions at Wyeth / Pfizer Inc.,
Johnson & Johnson (J&J) and Centocor. In these positions,
he had responsibility for sales and marketing, including the
commercialization of multiple hospital-based products, business and
commercial development, and multiple drug development
programs.
"Discovery Labs is committed to building a robust business that
is founded on its novel KL4 surfactant and aerosol delivery
technologies with the expressed goal of bringing transformational
change to neonatal respiratory critical care," said Mr.
Fraser. "I am very excited to have the opportunity to join a
very talented team at Discovery Labs and guide the Company through
the next phase of its growth while driving long-term stockholder
value."
Mr. Cooper has been with Discovery Labs for 14 years, serving as
its President, Chief Executive Officer and director since January
2013. Prior to that, Mr. Cooper served as President and Chief
Financial Officer from 2011 to 2012 and as its Executive Vice
President and Chief Financial Officer from 2001 to 2010.
"I want to thank John for his many years of dedicated service to
Discovery Labs and his steadfast and passionate commitment to
achieving the Company's goal of applying its technologies to
improve the care of fragile premature infants with respiratory
distress syndrome. We wish John well in his future
endeavors," commented Mr. Leone.
AEROSURF Program Update
- In the fourth quarter of 2015, the Company announced top-line
results of its previously completed AEROSURF phase 2a clinical
program in 80 premature infants 29 to 34 week gestational age (GA)
receiving nasal continuous positive airway pressure (nCPAP) for
respiratory distress syndrome (RDS). The program consisted of
two multicenter, randomized, open-label, controlled studies that
were designed to evaluate the safety and tolerability of
aerosolized KL4 surfactant administered in five dose groups (15,
30, 45, 60 and 90 minutes), compared to infants receiving nCPAP
alone. Key objectives of the program were achieved,
including:
- Overall, the safety and tolerability profile of the
AEROSURF-treated groups was generally comparable to the control
group. All reported adverse events and serious adverse events
were those that are common and expected among premature infants
with RDS.
- Data suggest that AEROSURF may be reducing the incidence of
nCPAP failure (the need for intubation and delayed surfactant
therapy).
- Also in the fourth quarter of 2015, the Company initiated a
phase 2a clinical trial in 32 premature infants 26 to 28 week GA
receiving nCPAP for RDS. This clinical trial is a multicenter,
randomized, open-label, controlled study that is designed to
evaluate the safety and tolerability of aerosolized KL4 surfactant
(including with potential repeat doses) administered in two dose
groups (30 and 45 minutes), compared to infants receiving nCPAP
alone. The start-up activities for the trial have taken
longer than anticipated at some clinical sites, due primarily to
administrative matters and, with fewer sites initiated, enrollments
are accruing more slowly than anticipated. As a result, the
Company anticipates completing enrollment of this phase 2a trial in
the second quarter of 2016 and releasing top-line results shortly
thereafter in the third quarter of 2016.
- Based on the safety and tolerability profile observed to date
in the phase 2a clinical program, the Company has initiated the
AEROSURF phase 2b clinical trial in premature infants 26 to 32
weeks GA receiving nCPAP for RDS. The trial is a multicenter,
randomized, controlled study with masked treatment assignment in
approximately 240 premature infants and is designed to evaluate the
safety and tolerability of aerosolized KL4 surfactant (including
with potential repeat doses) administered in two dose groups (25
and 50 minutes), compared to infants receiving nCPAP alone.
The following endpoints will be evaluated: time to nCPAP failure
(the need for intubation and delayed surfactant therapy), incidence
of nCPAP failure and physiological parameters indicating the
effectiveness of lung function. The trial is expected to be
conducted in up to 60 clinical sites in the United States, Canada, Europe and Latin
America. Enrollment is beginning with premature
infants 29 to 32 weeks GA, and will include premature infants 26 to
28 weeks GA after completion of the ongoing phase 2a clinical trial
in this age group. The Company anticipates completing
enrollment for the phase 2b clinical trial by the end of 2016 and
releasing top-line results in the first quarter of 2017.
As of December 31, 2015, the
Company had cash and cash equivalents of $38.7 million, an amount the Company
anticipates is sufficient to support the AEROSURF phase 2 clinical
program and fund operations through the first quarter of 2017.
About AEROSURF®
Premature infants with
severe RDS currently are treated with surfactants that can only be
administered by endotracheal intubation supported with mechanical
ventilation, invasive procedures that may each result in serious
respiratory conditions and other complications. To avoid such
complications, many neonatologists treat infants with less severe
RDS by less invasive means, typically nCPAP. Unfortunately, a
significant number of premature infants on nCPAP will respond
poorly (an outcome referred to as nCPAP failure) and may require
delayed surfactant therapy. Since neonatologists currently
cannot predict which infants will experience nCPAP failure, they
are faced with difficult choices in treating infants with less
severe RDS. This is because the medical outcomes for those
infants who experience nCPAP failure and receive delayed surfactant
therapy may be less favorable than the outcomes for infants who
received surfactant therapy in the first hours of life.
AEROSURF is a novel, investigational drug/device product that
combines the Company's proprietary KL4 surfactant and its
aerosolization technologies. AEROSURF is being developed to
potentially reduce or eliminate the need for endotracheal
intubation and mechanical ventilation in the treatment of premature
infants with respiratory distress syndrome (RDS). With
AEROSURF, neonatologists may potentially administer aerosolized KL4
surfactant to premature infants supported by nCPAP, without
subjecting them to invasive endotracheal intubation and mechanical
ventilation (each of which can result in serious respiratory
conditions and other complications), which are currently required
to administer surfactant therapy to premature infants. By
enabling delivery of aerosolized KL4 surfactant using less invasive
procedures, AEROSURF, if approved, has the potential to address a
serious unmet medical need, provide transformative clinical and
pharmacoeconomic benefits, and enable the treatment of a
significantly greater number of premature infants with RDS who
could benefit from surfactant therapy but are currently not
treated.
The Company estimates that there are currently approximately
120,000 to 150,000 premature infants in the U.S. who could benefit
from surfactant therapy. However, due to the risks associated
with endotracheal intubation and mechanical ventilation, only
approximately 50,000 to 60,000 of these infants currently are
treated with surfactants as the initial therapy for severe
RDS. The remaining infants with less severe RDS are usually
supported with nCPAP alone. However, a large percentage of
these infants are not adequately supported with nCPAP alone (an
outcome referred to as nCPAP failure) and thereafter may require
delayed surfactant therapy administered by endotracheal intubation
and mechanical ventilation
About Discovery Labs
Discovery Laboratories, Inc. is
a biotechnology company focused on developing aerosolized KL4
surfactant therapies for respiratory diseases. Surfactants
are produced naturally in the lung and are essential for normal
respiratory function and survival. If surfactant deficiency
or degradation occurs, the air sacs in the lungs can collapse,
resulting in severe respiratory diseases and disorders.
Discovery Labs' technology platform includes a novel synthetic
peptide-containing (KL4) surfactant, that is structurally similar
to pulmonary surfactant, and proprietary drug delivery technologies
being developed to enable efficient delivery of aerosolized KL4
surfactant. Discovery Labs believes that its proprietary
technology platform makes it possible, for the first time, to
develop a significant pipeline of aerosolized surfactant products
to address a variety of respiratory diseases for which there
frequently are few or no approved therapies.
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, 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 affecting Discovery Labs' ability successfully to complete
its development programs, secure regulatory approvals for its
product candidates in the U.S. and abroad, and realize the
potential value and benefits of its RDS product portfolio, are
described in Discovery Labs' filings with the Securities and
Exchange Commission, including its 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.
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SOURCE Discovery Laboratories, Inc.