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8-K - WINDTREE THERAPEUTICS INC /DE/ | v207785_8k.htm |
Exhibit
99.1
Discovery Labs Provides Update Regarding
its Program for Surfaxin® U.S. Marketing
Authorization
Warrington, PA — January 10, 2011
— Discovery Laboratories,
Inc. (Nasdaq: DSCOD), a biotechnology company developing its
novel, synthetic, peptide-containing surfactant, is providing an update
regarding its efforts to file a Complete Response intended to gain U.S. Food and
Drug Administration (FDA) marketing authorization of Surfaxin® for the prevention of respiratory
distress syndrome (RDS) in premature infants. Discovery Labs has had multiple
interactions with the FDA regarding various aspects of the final validation of
an important quality control release and stability test for Surfaxin, the fetal
rabbit biological activity test (BAT). In response to a proposal submitted by
Discovery Labs, the FDA has recently provided detailed, written direction
regarding the verification of certain parameters related to final BAT
validation. The FDA indicated that several aspects of Discovery Labs’ proposed
approach to the BAT validation are reasonable; however, with respect to certain
parameters, the FDA is requesting additional data to further support ultimate
determination of BAT validation.
W. Thomas Amick, Chairman of the Board
and Chief Executive Officer of Discovery Labs commented, “We have made considerable
progress towards the filing of a Surfaxin Complete Response. The work that we originally
proposed to the FDA relating to the comprehensive preclinical program has been
completed. We have generated data that demonstrate a meaningful reduction in
variability in the optimized BAT and have conducted supportive side-by-side
studies with the well-established pre-term lamb model of RDS. We appreciate the
FDA’s willingness to provide guidance and, based on our preliminary assessment,
believe that we could generate the additional data and be in a position to file
a Surfaxin Complete Response by early third quarter 2011.”
Discovery Labs has conducted a
comprehensive pre-clinical program employing an optimized BAT in a series of
prospectively-designed, side-by-side preclinical studies with the
well-established preterm lamb model of RDS. Discovery Labs engaged in several
interactions with the FDA intended to ensure that the comprehensive preclinical
program would satisfy the FDA. At the FDA’s suggestion, Discovery Labs submitted
a proposal seeking clarification regarding specific and detailed aspects of
final BAT validation. To address certain technical criteria relating to final
BAT validation, the FDA’s recent correspondence advises Discovery Labs to
increase the sample size of a specific data set by testing additional Surfaxin
batches. Discovery Labs currently has data from batches that have already been
manufactured and, to be responsive to the FDA’s advice, anticipates
manufacturing additional batches in January and February of this
year.
Later this month, Discovery Labs expects
to provide to the public a detailed overview of its program and anticipates
holding a conference call.
DISCLOSURE NOTICE:
The information in this
press release includes certain “forward-looking” statements relating, among
other things, to Discovery Labs’ understanding of the recently-received written
guidance from the FDA and the remaining questions identified in the FDA’s April
2009 Complete Response Letter that must be addressed to gain FDA approval of
Surfaxin. Although Discovery Labs currently believes that it may still succeed
in submitting a Complete Response and gaining approval of its NDA for Surfaxin
for the prevention of RDS in premature infants, anticipated activities will
require that Discovery Labs raise significant amounts of additional capital.
Discovery Labs has initiated activities relating to this most recent FDA
communication and anticipates potential further interactions with the FDA in
advance of filing a Complete Response. Such potential interactions with the FDA
could affect the ultimate timing, conduct and outcomes of remaining steps
necessary to gain Surfaxin approval, including the potential filing of the
Complete Response. In addition, these activities and the ultimate outcomes
remain subject to a variety of risks and uncertainties that could cause actual
results to be materially different. These risks and uncertainties include, but
are not limited to, risks that (i) the FDA may not approve Surfaxin or may
subject the marketing of Surfaxin to onerous requirements that significantly
impair marketing activities; (ii) Discovery Labs may be unable to complete the
manufacture of additional Surfaxin batches within the time frame set forth
above, (iii) Discovery Labs may identify unforeseen problems that have not yet
been discovered or the FDA could in the future impose additional requirements to
gain approval of Surfaxin; and (iv) Discovery Labs may be unable to raise
sufficient additional capital, through financings, strategic collaborations, or
otherwise. Any failure to satisfy the issues raised by the FDA, in the Complete
Response letter or in related discussions, could significantly delay, or
preclude outright, gaining approval of Surfaxin, which could potentially delay
or prevent the approval of Discovery Labs’ other products.
Surfaxin is an investigational drug
product and is not approved by the FDA or any other world health regulatory
authority for use in humans. If approved, Surfaxin would become the first
synthetic, peptide-containing surfactant for commercial use in neonatal
medicine.
About Discovery Labs
Discovery Laboratories, Inc. is a
biotechnology company developing surfactant therapies 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 and is being developed in liquid, aerosol or lyophilized
formulations. In addition, Discovery Labs’ proprietary capillary aerosolization
technology produces a dense aerosol, with a defined particle size that is
capable of potentially delivering aerosolized KL4 surfactant to the lung without the
complications currently associated with liquid surfactant administration.
Discovery Labs believes that its proprietary technology platform makes it
possible, for the first time, to develop a significant pipeline of surfactant
products to address a variety of respiratory diseases for which there frequently
are few or no approved therapies. For more information, please visit our 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 related to the Company’s comprehensive
non-clinical program, development and manufacturing activities and related
regulatory efforts, 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.
Contact Information:
John G. Cooper, President and Chief
Financial Officer
215-488-9490