Discovery Labs Provides Commercial Update for SURFAXIN® and AFECTAIR®
Conference Call Today at 10:00 am EDT - Details Below
WARRINGTON, Pa., Oct. 24, 2012
WARRINGTON, Pa., Oct. 24, 2012 /PRNewswire/ -- Discovery Laboratories, Inc.
(Nasdaq: DSCO), a specialty biotechnology company dedicated to advancing a new
standard in respiratory critical care, today reports a commercial update for
SURFAXIN^® and AFECTAIR^®. The Company has initiated commercial launch
activities for both products by training and deploying its newly-formed
commercial and medical affairs organizations with the goal of securing
hospital formulary acceptance for SURFAXIN, expected to be commercially
available in the second quarter of 2013, and adoption of AFECTAIR with an
anticipated product availability in December 2012.
As the Company continues to make progress in its launch readiness efforts,
Discovery Labs has:
oHeld its first national meeting to welcome and complete the training of
its newly-hired field sales force, national accounts team and medical
science liaison team,
oDeployed its field force with the primary objective of gaining hospital
formulary acceptance for SURFAXIN and adoption of AFECTAIR,
oExecuted or is finalizing group purchasing organization and national
oContinues to manufacture SURFAXIN at a commercial scale as it has for
oEstablished supply chain distribution and warehouse arrangements,
oEnhanced its quality control and assurance infrastructure with additional
hiring of highly-qualified scientific, technical and analytical personnel
and systems implementation.
During a recent review of the results and processes related to the analytical
testing and quality control of SURFAXIN drug product, Discovery Labs
determined that one of its analytical chemistry methods used to assess its
drug product's conformance to specifications requires improvement and that an
update to product specifications will be necessary. Discovery Labs has
proactively communicated its findings regarding this analytical method to the
U.S. Food and Drug Administration (FDA), has initiated a plan to improve and
validate its analytical method, and plans to submit updated product
specifications to the FDA. Based on the anticipated time required to improve
the method, submit updated specifications, and await confirmation from the
FDA, Discovery Labs anticipates that, if its plan is successful, the
availability of SURFAXIN drug product will be delayed until early in the
second quarter of 2013. This is not expected to have a material adverse
effect on the Company's business or financial position, in part, because the
Company's commercial launch plan for SURFAXIN during this period has always
been to focus initially on formulary acceptance.
Discovery Labs anticipates commercial availability of its initial AFECTAIR
device in December 2012. This initial device is intended for use in infants
receiving ventilatory support in the neonatal and pediatric intensive care
units (NICU, PICU). Because Discovery Labs expects that the same hospitals
that purchase SURFAXIN are likely to purchase AFECTAIR, the Company's
commercial and medical affairs organizations will be responsible for the
commercial introduction of this product.
Conference Call and Webcast Details
Discovery Labs will hold a conference call and webcast today at 10:00 AM EDT
to discuss the foregoing. A live webcast of the conference call, including a
slide presentation, is available at
www.discoverylabs.com. An archive of the webcast will be available on
Discovery Labs' Investor Relations web site.
For "listen-only" participants and those who wish to take part in the question
and answer portion of the call, the dial-in numbers are (866) 332-5218 (U.S.)
or (706) 679-3237 (international). The passcode for the call is 55058190.
A replay of the conference call will be available through October 31, 2012.
The replay number is (855) 859-2056 or (404) 537-3406 using the same
conference call passcode listed above. A replay will also be available at
SURFAXIN (lucinactant) intratracheal suspension is indicated for the
prevention of respiratory distress syndrome (RDS) in premature infants at high
risk for RDS. SURFAXIN is the first and only peptide-containing, surfactant
approved by the FDA and the only alternative to animal-derived surfactants.
SURFAXIN is intended for intratracheal use only. The administration of
exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and
lung compliance. SURFAXIN should be administered only by clinicians trained
and experienced with intubation, ventilator management, and general care of
premature infants in a highly supervised clinical setting. Infants receiving
SURFAXIN should receive frequent clinical assessments so that oxygen and
ventilatory support can be modified to respond to changes in respiratory
status. Most common adverse reactions associated with the use of SURFAXIN are
endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for
dose interruption. During SURFAXIN administration, if bradycardia, oxygen
desaturation, endotracheal tube reflux, or airway obstruction occurs,
administration should be interrupted the infant's clinical condition assessed
and stabilized. SURFAXIN is not indicated for use in acute respiratory
distress syndrome (ARDS). For more information about SURFAXIN, please visit
www.surfaxin.com. Information contained in, or accessible through, this
website does not constitute a part of, and is not incorporated into, this
AFECTAIR was developed initially as part of the AEROSURF^® development program
and is being developed as a series of proprietary disposable ventilator
circuit/patient interface connectors that simplify the delivery of aerosolized
medications to critical-care patients requiring ventilatory support. According
to national health statistics and market assessment data, it is estimated that
each year more than 1.3 million patients in the United States and European
Union receive aerosolized medications while requiring ventilator support.
Discovery Labs is implementing a business plan that potentially will allow for
the commercial introduction of the initial AFECTAIR device in the United
States in late 2012.
Readers are referred to, and encouraged to read in their entirety, the Form
8-K that Discovery Labs filed with the Securities and Exchange Commission
(SEC) concurrently with the issuance of this press release, and Discovery
Labs' Quarterly Report on Form 10-Q for the quarter ended September 30, 2012
to be filed with the SEC, which includes further detail on the Company's
business plans and operations, financial condition and results of operations.
The information in this press release includes certain "forward-looking"
statements relating, among other things, to Discovery Labs' plans to
manufacture and release SURFAXIN drug product for commercial sale, including
plans to execute a program to improve and validate a particular analytical
chemistry method, and prepare and submit to the FDA information supporting a
request to update SURFAXIN product specifications. These and other similar
statements included herein are forward-looking and are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of
1995. While Discovery Labs currently believes that it will succeed in meeting
the timelines outlined above, such forward-looking statements are subject to a
variety of risks and uncertainties that could cause actual results to be
materially different. Examples of such risks and uncertainties, including
those related to the Company's research and development programs, are
described in Discovery Labs' filings with the SEC, 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
SOURCE Discovery Laboratories, Inc.
Contact: Media Relations, Michael Parks, Pitch360, +1-484-356-7105,
Michael@pitch360inc.com; Investor Relations, Michael Rice, LifeSci Advisors,
+1-917-282-3242 or John G. Cooper, President and Chief Financial Officer,
Press spacebar to pause and continue. Press esc to stop.