WARRINGTON, Pa., Oct. 15, 2014 /PRNewswire/ -- Discovery
Laboratories, Inc. (Nasdaq: DSCO) today announced that it has
entered into a strategic collaboration with Battelle, the world's
largest independent research and development organization with 35
years of specific expertise in aerosol science. The parties intend
to further develop Discovery Labs' proprietary capillary aerosol
generator (CAG) for use in the planned AEROSURF® phase 3 clinical
program and, if approved, initial commercialization. The
arrangement also reflects the plan to negotiate agreements to
provide for the manufacture of phase 3 clinical devices and, if
AEROSURF is approved, initial commercial supply. The CAG is
currently being used in neonatal intensive care units for the
company's AEROSURF phase 2 clinical program for the treatment of
respiratory distress syndrome (RDS) in premature infants. Battelle
and Discovery Labs generally will share equally in the agreed costs
of the device development for the AEROSURF RDS program. In
consideration for its investment and expertise, Battelle will
receive warrants and future royalties on AEROSURF sales and license
sales revenues.
"This collaboration brings us a partner with world class
capabilities in aerosol device design and manufacture, in addition
to the clear financial benefits," commented John G. Cooper, Discovery Labs' President and
Chief Executive Officer. "Battelle has a successful track record of
working with companies developing medical devices from development
stage through ultimate FDA approval. They also have extensive
experience with our aerosolization technology, and played a key
role in preparing the CAG for use in our current AEROSURF phase 2
program. Now we are going to leverage those experiences and their
development, quality and regulatory expertise to further support
the AEROSURF opportunity. We look forward to our continued and
expanded relationship."
"One of our missions is to support what we believe to be
transformational medical advances," commented Bob Wilkins, MBChB, FRCA, a Battelle Vice
President of Strategic Development. "Based on our work to date and
our assessment of the opportunity, we believe that AEROSURF
addresses a significant unmet medical need, and represents a
potential revolution in the management of infants with respiratory
distress syndrome. We are excited to combine our expertise in
aerosol drug delivery device development with Discovery Labs'
expertise in synthetic surfactant technology and neonatal RDS."
Under the terms of the agreement, Battelle and Discovery Labs
will co-invest in the development of an AEROSURF phase 3
clinic-ready aerosol device. Upon execution of the agreement,
Battelle received two warrants to purchase a total of 1.5 million
shares of Discovery Labs' common stock at an exercise price of
$5.00 per share, each warrant with a
10-year term. The first warrant to purchase 1 million shares is
exercisable only upon successful development of an aerosol device
that is ready for a potential AEROSURF phase 3 clinical program.
The second warrant to purchase 0.5 million shares will become
exercisable only upon meeting the aforementioned milestone by a
certain date. In addition, if AEROSURF receives regulatory approval
for the treatment of RDS, Battelle will receive a low single-digit
royalty on Discovery Labs' AEROSURF commercial revenues, subject to
an aggregate cap of $25 million.
AEROSURF is a novel investigational combination drug-device
product being developed to deliver the company's synthetic KL4
surfactant in aerosolized form via nasal continuous positive airway
pressure (nCPAP) to premature infants with 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 is developing its proprietary
aerosolization drug delivery technologies, including the CAG, to
enable efficient delivery of aerosolized KL4 surfactant. The
company is currently conducting a phase 2 clinical program for
AEROSURF employing the current version of the CAG.
The information included in this press release about Discovery
Labs' collaboration with Battelle is subject in its entirety to the
definitive terms of the collaboration agreement, the warrants and
other related documents. Additional information, including a
description of the collaboration documents, is provided in a
Current Report on Form 8-K that is expected to be filed today with
the Securities and Exchange Commission ("SEC"). A redacted version
of the agreement together with other collaboration documents, is
expected to be filed with Discovery Labs' Quarterly Report on Form
10-Q for the period ending September 30,
2014, which is expected to be filed with the SEC on or
before November 10, 2014.
This press release is neither an offer to sell nor a
solicitation of an offer to buy the securities discussed herein,
nor shall there be any sale of securities in any state or other
jurisdiction in which such offer, solicitation, or sale would be
unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction.
About Discovery Labs
Discovery Laboratories, Inc. is a
specialty biotechnology company focused on advancing a new standard
in respiratory critical care. Discovery Labs' technology
platforms include a novel proprietary KL4 surfactant, a synthetic,
peptide-containing 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' 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 has the potential to become the new
standard of care for RDS and, over time, to enable the treatment of
a significantly greater number of premature infants who could
benefit from surfactant therapy but are currently not treated.
SURFAXIN® (lucinactant) Intratracheal Suspension, Discovery
Labs' first KL4 surfactant-based product, is the only available
synthetic alternative to animal derived surfactants approved by the
U.S. Food and Drug Administration (FDA). Full prescribing
information can be found at http:///www.surfaxin.com.
For more information, please visit the company's website at
www.Discoverylabs.com.
About Battelle
Every day, the people of Battelle apply science and technology to
solving what matters most. At major technology centers and national
laboratories around the world, Battelle conducts research and
development, designs and manufactures products, and delivers
critical services for government and commercial customers.
Headquartered in Columbus, Ohio
since its founding in 1929, Battelle serves the national security,
health and life sciences, and energy and environmental industries.
For more information, visit www.battelle.org.
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. Forward-looking statements often include
words such as "will," "intends," "plans," "believes" and words and
terms of similar substance. 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 (including AEROSURF), 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.