WARRINGTON, Pa., March 30, 2009 (GLOBE NEWSWIRE) --
Discovery Laboratories, Inc. (Nasdaq:DSCO) will present to the
investment community at the BioCentury Future Leaders in the
Biotech Industry Conference on Thursday, April 2, 2009. The
presentation will highlight Discovery Labs' broad development
pipeline of surfactant therapies to treat respiratory
diseases.
Robert J.
Capetola, Ph.D., President and Chief Executive Officer of Discovery
Labs, commented, "We are pioneering some of the most exciting
science in the development of new surfactant applications and
delivery approaches to improve respiratory critical care medicine.
A variety of respiratory disorders are associated with surfactant
deficiency or surfactant degradation. We believe that our
proprietary technology platform makes it possible, for the first
time, to develop a significant pipeline of therapeutic surfactant
products, targeted to treat a wide range of respiratory
conditions."
Discovery Labs' novel proprietary KL4 surfactant technology
produces a synthetic, peptide-containing surfactant that is
structurally similar to pulmonary surfactant, a substance produced
naturally in the lung and essential for survival and normal
respiratory function. In addition, Discovery Labs' proprietary
capillary aerosol generating technology (Capillary Aerosolization
Technology) produces a consistent, dense surfactant aerosol with a
defined particle size, to potentially deliver aerosolized KL4
surfactant to the distal lung.
Discovery Labs' Pipeline for Respiratory Disorders
Discovery Labs is focused initially on developing its pipeline
to build a pediatric franchise that will potentially address
several respiratory diseases affecting neonates and young children.
Serious respiratory problems are some of the most prevalent medical
issues facing premature infants in neonatal intensive care units.
Respiratory Distress Syndrome (RDS) is one of the most common,
acute, potentially life-threatening disorders with approximately
360,000 low birth weight premature infants at risk annually in the
United States. Discovery Labs believes that the RDS market
represents a significant opportunity from both a medical and
business perspective.
* Surfaxin(r) (lucinactant) for the prevention of RDS is the
first synthetic, peptide-containing surfactant that, if approved,
will represent an alternative to the currently approved
animal-derived surfactants. The U.S. Food and Drug Administration
(FDA) has established April 17, 2009 as its target action date to
complete its review and potentially grant marketing approval.
* Aerosurf(r) is KL4 surfactant in aerosolized form using
Discovery Labs' proprietary Capillary Aerosolization Technology.
Premature infants with RDS are treated with surfactants that are
administered by means of invasive endotracheal intubation and
mechanical ventilation. The current RDS management approach, while
life-saving, often results in serious respiratory conditions and
complications due to the invasive method of administration.
Aerosurf, if successfully developed, holds the promise to
significantly expand the use of KL4 surfactant in pediatric
respiratory medicine by providing neonatologists with a novel means
of potentially delivering KL4 surfactant while avoiding the risks
associated with invasive endotracheal intubation and mechanical
ventilation. Discovery Labs has met with and received guidance from
the FDA with respect to the design of its planned Phase 2 clinical
program, which is expected to be initiated in late 2009 or early
2010.
* Surfaxin LS(tm) is the lyophilized formulation of Surfaxin,
which is manufactured as a dry powder and reconstituted as a liquid
prior to administration. Lyophilized KL4 surfactant has the
potential to improve product flexibility and ease of use for
healthcare practitioners, eliminate the need for cold-chain storage
and may demonstrate characteristics that further improve product
clinical performance. Discovery Labs is planning to meet with
regulatory authorities this year with a view towards initiating a
worldwide, late-stage clinical development program in 2010 for
Surfaxin LS for the prevention of RDS.
* Discovery Labs is conducting a Phase 2 clinical trial to
determine if treatment with Surfaxin improves lung function and
reduces duration of mechanical ventilation in children up to two
years of age suffering from Acute Respiratory Failure (ARF). ARF
typically occurs following a serious respiratory infection such as
respiratory-syncytial virus or influenza, leading to an impairment
in lung function (including reduced levels of functional
surfactant) and the need for endotracheal intubation and mechanical
ventilation (no medications are currently approved for this
debilitating condition).
Discovery Labs' technology platform is also being developed to
target other pediatric and adult respiratory disorders associated
with surfactant degradation for which there currently are limited
or no approved therapies.
* Aerosolized KL4 surfactant has been selected for use in a
Phase 2a clinical trial in patients with Cystic Fibrosis (CF),
potentially taking advantage of the mucomodulatory properties of
KL4 surfactant. This investigator-initiated study is being
conducted at The University of North Carolina and is funded through
a grant provided by the Cystic Fibrosis Foundation. The trial is
designed to evaluate whether aerosolized KL4 surfactant is safe and
well tolerated in patients with mild to moderate CF lung disease,
and to assess the short-term effectiveness of aerosolized KL4
surfactant. We anticipate the results from this trial in late
2009.
* Multiple proof-of-concept preclinical studies are ongoing
employing Discovery Labs' KL4 surfactant and the Capillary
Aerosolization Technology platform, in models of Acute Lung Injury
(ALI) and to assess the potential of drug combination therapies
(aerosolized KL4 surfactant in combination with other drug
compounds) to address respiratory diseases such as COPD and CF.
Presentation Logistics
Discovery Labs' President and Chief Executive Officer, Dr.
Robert J.Capetola, is scheduled to present at 11:00 A.M. DST on
Thursday, April 2, 2009 in New York. The conference will be
simultaneously webcast over the Internet. The presentation will be
available through a live audio webcast at
http://www.corporate-ir.net/ireyeconflobby.zhtml?ticker=DSCO&item_id=2123884
or Discovery Labs' web site, www.discoverylabs.com. A replay of the
audio webcast will be available on both websites for thirty
days.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company
developing Surfactant Replacement Therapies (SRT) for respiratory
diseases. Surfactants are produced naturally in the lungs and are
essential for breathing. Discovery Labs' novel proprietary KL4
Surfactant Technology produces a synthetic, peptide-containing
surfactant that is structurally similar to pulmonary surfactant. In
addition, Discovery Labs' proprietary capillary aerosol generating
technology produces a dense aerosol with a defined particle size,
to potentially deliver aerosolized KL4 Surfactant to the deep lung.
Discovery Labs believes that its proprietary technology platform
makes it possible, for the first time, to develop a significant
pipeline of surfactant products targeted to address a variety of
respiratory diseases affecting neonatal, pediatric and adult
patients.
Discovery Labs' lead product from its KL4 Surfactant pipeline is
SURFAXIN(r) for the prevention of Respiratory Distress Syndrome in
premature infants. The U.S. Food and Drug Administration (FDA) has
established April 17, 2009 as its target action date to complete
its review of this new drug application (NDA) and potentially grant
marketing approval for SURFAXIN. AEROSURF(r), Discovery Labs'
aerosolized KL4 Surfactant, is being developed to potentially
obviate the need for intubation and conventional mechanical
ventilation and holds the promise to significantly expand the use
of surfactants in respiratory medicine. For more information,
please visit our website at www.Discoverylabs.com.
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 are: risks relating
to the rigorous regulatory requirements required for approval of
any drug or drug-device combination products that the Company may
develop, including that (i) the Complete Response to the May 2008
Approvable Letter for Surfaxin that the Company submitted to the
U.S. Food and Drug Administration (FDA) in October 2008 will not
satisfy the FDA, (ii) the FDA or other regulatory authorities may
not accept or may withhold or delay consideration of any of the
Company's applications,or may not approve or may limit approval of
the Company's products to particular indications or impose
unanticipated label limitations, and (iii) that changes in the
national or international political and regulatory environment may
make it more difficult to gain FDA or other regulatory approval;
risks relating to the Company's research and development
activities, including time-consuming and expensive pre-clinical
studies, clinical trials and other efforts, which may be subject to
potentially significant delays or regulatory holds, or fail; risks
relating to the Company's ability to develop and manufacture drug
products and capillary aerosolization systems for clinical studies,
and, if approved, for commercialization of drug and combination
drug-device products, including risks of technology transfers to
contract manufacturers and problems or delays encountered by the
Company, its contract manufacturers or suppliers in manufacturing
drug products, drug substances and capillary aerosolization systems
on a timely basis or in an amount sufficient to support the
Company's development efforts and, if approved, commercialization;
risks that (a) market conditions, the competitive landscape or
otherwise, may make it difficult to launch and profitably sell
products, (b) the Company may be unable to build a successful sales
and marketing organization to market its products, if approved,in a
timely manner, if at all, and (c) the Company's products will not
gain market acceptance by physicians, patients, health care payers
and others in the medical community; the risk that the Company or
its strategic partners or collaborators will not be able to attract
or maintain qualified personnel; the risk that the Company will not
be able in a changing financial market to raise additional capital
or enter into strategic alliances or collaboration agreements, or
that the ongoing credit crisis will adversely affect the ability of
the Company to fund its activities, or that additional financings
could result in substantial equity dilution; the risk that the
Company will not be able to access credit from its committed equity
financing facilities, or that the share price at which the Company
may access the facilities from time to time will not enable the
Company to access the full dollar amount potentially available
under the facilities; the risk that the Company will be unable to
maintain The Nasdaq Global Market listing requirements, causing the
price of the Company's common stock to decline; the risk that
recurring losses, negative cash flows and the inability to raise
additional capital could threaten the Company's ability to continue
as a going concern; the risks that the Company may be unable to
maintain and protect the patents and licenses related to its
products, or other companies may develop competing therapies and/or
technologies, or health care reform may adversely affect the
Company; risks of legal proceedings, including securities actions
and product liability claims; risks relating to reimbursement and
health care reform; and other risks and uncertainties described in
the Company'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.