WARRINGTON, Pa., April 16, 2015 /PRNewswire/ -- Discovery
Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology
company focused on developing aerosolized KL4 surfactant
therapies for respiratory diseases, today announced that it has
completed enrollment in its AEROSURF® phase 2a clinical
trial assessing the administration of a single dose of AEROSURF in
premature infants 29-34 week gestational age (GA) with respiratory
distress syndrome (RDS). The company also is implementing a
restructuring plan to voluntarily cease the commercialization of
SURFAXIN® (lucinactant) Intratracheal Suspension and
focus its resources on the development of its aerosolized
KL4 surfactant for respiratory diseases, beginning with
AEROSURF.
AEROSURF
The AEROSURF phase 2a trial is a multi-center, open-label trial
to evaluate safety and tolerability of a single dose of aerosolized
KL4 surfactant in premature infants (n = 48) 29 to 34
weeks GA who are receiving nasal continuous positive airway
pressure (nCPAP) for RDS, compared to infants receiving nCPAP
alone. The study evaluated three escalating doses of
AEROSURF. In addition to evaluating safety and tolerability,
another key objective is to establish proof of concept for the
company's proprietary technology platform with (1) physiological
data indicating that aerosolized KL4 surfactant is being
effectively delivered into the lung of premature infants, and (2)
acceptable performance by the novel capillary aerosol generator
(CAG) technology in the neonatal intensive care unit (NICU).
The company anticipates releasing the results of this trial
and holding an investor conference call in approximately three to
four weeks.
AEROSURF is the company's investigational combination
drug/device product that combines its synthetic KL4
surfactant with its proprietary CAG. If AEROSURF is
successfully developed and approved, neonatologists will be able to
administer aerosolized KL4 surfactant to premature
infants receiving nCPAP, without having to use invasive methods
(intubation and mechanical ventilation – procedures that may each
result in serious respiratory conditions and other complications)
that currently are required to administer all surfactants.
AEROSURF potentially will address this unmet medical need and
may make possible the treatment of a significantly greater number
of premature infants with RDS who could benefit from surfactant
therapy but are currently not treated.
SURFAXIN
SURFAXIN is the company's first synthetic, peptide-containing
(KL4) surfactant approved by the FDA for RDS. The
company has made significant cash investments to support SURFAXIN
including in manufacturing, marketing, medical and commercial
activities. In 2014, cash outflows for those activities were
approximately $19.0 million.
The decision to cease the commercialization of SURFAXIN is
not based on any underlying safety or efficacy concern, but rather
is compelled by the company's desire to preserve capital to advance
AEROSURF and the KL4 surfactant pipeline.
The company initiated a plan that included actively pursuing a
strategic alliance for SURFAXIN if it could be concluded on
acceptable terms and within a reasonable time, but if such an
alliance or collaboration arrangement could not be achieved, it
planned to cease the commercialization of SURFAXIN. After
evaluating the potential strategic alternatives, none of which
could be accomplished on acceptable terms within a reasonable
period of time, the company determined that ceasing the
commercialization of SURFAXIN aligned best with its objectives to
preserve (i) its rights and interests in AEROSURF and its
KL4 surfactant pipeline and (ii) its capital to advance
the AEROSURF clinical program.
As a result of the restructuring, the company's workforce will
be reduced by approximately 50 percent, predominantly in commercial
infrastructure and SURFAXIN manufacturing capabilities. The
company expects to record a one-time restructuring charge of
approximately $3.5 million in the
second quarter of 2015. The company anticipates it will have
sufficient cash available to support its operations and debt
service obligations through the first quarter of 2016.
John G. Cooper, Discovery Labs'
President and Chief Executive Officer commented, "We believe that
this strategic restructuring to focus on advancing AEROSURF and our
pipeline has the potential to generate the greatest value for our
stakeholders."
About Discovery Labs
Discovery Laboratories, Inc. is a
specialty biotechnology company focused on developing aerosolized
KL4 surfactant therapies for respiratory diseases.
Surfactants are produced naturally in the lungs and are critical to
survival and normal respiratory function. If surfactant
deficiency or degradation occurs, the air sacs in the lungs can
collapse, resulting in severe respiratory diseases and
disorders. Discovery Labs' technology platforms include 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.
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, including projections of future cash balances and
anticipated cash outflows, to differ materially from the statements
made. Examples of such risks and uncertainties include
without limitation: risks that Discovery Labs will be unable to
secure significant additional capital as needed; risks related to
the AEROSURF and other development programs, which may involve
time-consuming and expensive pre-clinical studies and clinical
trials that may be subject to potentially significant delays or
regulatory holds, or fail; risks related to technology transfers to
contract manufacturers and problems or delays encountered by
Discovery Labs, contract manufacturers or suppliers in
manufacturing drug products, drug substances, capillary aerosol
generator devices and other materials on a timely basis and in
sufficient amounts; risks relating to the rigorous regulatory
requirements governing drug development activities; and other risks
and uncertainties 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/discovery-labs-completes-enrollment-of-aerosurf-phase-2a-clinical-trial-and-restructures-its-business-to-focus-on-development-of-aerosurf-and-aerosolized-kl4-surfactant-pipeline-300067422.html
SOURCE Discovery Laboratories, Inc.