Item 7.01. Regulation FD Disclosure.
On October 17, 2013, Discovery Laboratories, Inc. (the "Company" or "Discovery
Labs"), a specialty biotechnology company focused on advancing a new standard of
care for critical care patients with respiratory disease, will hold a conference
call and webcast to discuss its AEROSURF® program at 10:00 AM ET on October 17,
2013. A copy of the presentation materials is attached as Exhibit 99.1 hereto.
Pursuant to General Instruction B.2 of Form 8-K, the information in this Item
7.01 of this Current Report on Form 8-K and Exhibit 99.1 hereto are being
furnished and shall not be deemed "filed" for the purposes of Section 18 of the
Securities Exchange Act of 1934 or otherwise be subject to the liabilities of
that section, nor is it incorporated by reference into any filing of Discovery
Laboratories, Inc. under the Securities Act of 1933 or the Securities Exchange
Act of 1934, whether made before or after the date hereof, regardless of any
general incorporation language in such filing.
Item 8.01. Other Events.
On October 17, 2013
, the Company issued a press release announcing that it has
submitted an Investigational New Drug (IND) Application to the U.S. Food and
(FDA) for its initial AEROSURF phase 2 clinical trial. The
has confirmed receipt of the IND and has indicated that, unless otherwise
notified during its review, the Company may initiate its phase 2 clinical
program after a 30-day period. Discovery Labs
anticipates patient enrollment
could begin in the fourth quarter of 2013. The Company's press release is
attached as Exhibit 99.2 hereto.
AEROSURF is a novel investigational drug-device combination product being
developed to deliver Discovery Labs'
KL4 surfactant in aerosolized form to
premature infants with respiratory distress syndrome (RDS). AEROSURF combines
the Company's proprietary KL4 surfactant drug technologies with its proprietary
drug delivery technologies to potentially allow for the administration of
aerosolized KL4 surfactant to premature infants without the need for invasive
endotracheal intubation and mechanical 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.
In 2012, the FDA
approved the Company's first drug product, SURFAXIN®
(lucinactant) Intratracheal Suspension for the prevention of RDS in premature
infants who are at high risk for RDS. SURFAXIN is based on the Company's KL4
and is the first synthetic, peptide-containing surfactant
approved by the FDA
and the only alternative to animal-derived
surfactants. Using the foundation of the SURFAXIN KL4 surfactant drug
, the Company is developing a lyophilized (freeze-dried) dosage form
of KL4 surfactant that can be stored as a powder and resuspended to liquid form
prior to use, with the objective of improving ease of use for healthcare
practitioners, as well as potentially prolonging shelf life and eliminating the
need for cold-chain storage. The Company has completed a technology
the lyophilized surfactant manufacturing process and is developing this dosage
form with DSM Pharmaceuticals, Inc.
(DSM), its contract manufacturer with
expertise in lyophilized products. DSM has manufactured an initial supply of
clinical drug product and will manufacture the clinical drug supply needed to
complete the Company's phase 2 clinical program. The Company is planning with
DSM for the further development of this lyophilized KL4 surfactant, potentially
for its AEROSURF phase 3 program and commercial supply.