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Discovery Laboratories, Inc.
, 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:
o Held 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,
o Deployed its field force with the primary objective of gaining hospital
formulary acceptance for SURFAXIN and adoption of AFECTAIR,
o Executed or is finalizing group purchasing organization and national
account contracts,
o Continues to manufacture SURFAXIN at a commercial scale as it has for
several years,
o Established supply chain distribution and warehouse arrangements,
o Enhanced 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.
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