SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
___________________________
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
November
1, 2010
Date of
Report (Date of earliest event reported)
Discovery
Laboratories, Inc.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
000-26422
|
94-3171943
|
|
(State
or other jurisdiction
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
Number)
|
2600
Kelly Road, Suite 100
Warrington,
Pennsylvania 18976
(Address
of principal executive offices)
(215)
488-9300
(Registrant's
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item
8.01. Other
Events.
On
November 1, 2010, Discovery Laboratories, Inc. (the “Company”) announced that
the Office of Orphan Products Development of the United States Food and Drug
Administration has granted orphan drug designation to Discovery’s KL4 surfactant
for the treatment of cystic fibrosis.
The full
text of the press release is set forth in Exhibit 99.1 to this Current Report on
Form 8-K.
Item 9.01. Financial
Statements and Exhibits.
(d) Exhibits
|
|
99.1
|
Press
Release
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| Discovery Laboratories, Inc. | |||
|
|
By:
|
/s/ John G. Cooper | |
| Name: | John G. Cooper | ||
| Title: |
President,
Chief Financial Officer and
Treasures
|
||
Date: November
4, 2010
Discovery
Labs’ KL4
Surfactant Granted
Orphan Drug Designation for
the
Treatment of Cystic Fibrosis
Warrington, PA, November 1, 2010 —
Discovery Laboratories, Inc. (Nasdaq: DSCO), today announced that the
Office of Orphan Products Development of the United States Food and Drug
Administration (FDA) has granted orphan drug designation to Discovery’s KL4 surfactant
for the treatment of cystic fibrosis (CF). Orphan designation
provides for up to seven years of U.S. market drug product exclusivity for the
designated indication following marketing authorization.
Dr.
Thomas F. Miller, Discovery Labs’ Chief Operating Officer commented, “To date,
Discovery Labs has successfully procured orphan designations for several
respiratory disease targets in both the U.S. and Europe. We are pleased that the
FDA’s Office of Orphan Products Development has granted orphan designation for
KL4
surfactant for CF treatment.”
CF is
caused by a genetic mutation that leads to the production of thick, viscous
mucus that is difficult to clear from the airways of the lung. The
abnormal mucus allows for chronic airway infections that lead to airway
destruction, decreased lung function, and ultimately, death. Dr.
Miller continued, “Previous preclinical and exploratory clinical studies suggest
that surfactant may improve mucociliary clearance, thereby potentially
preventing further compromise of lung function. Our preclinical and recent
clinical experience suggests that CF may be a viable therapeutic target for our
aerosolized KL4 surfactant
technology.”
Discovery
recently announced the completion of a double-blind, randomized crossover Phase
2a study that evaluated the safety, tolerability and effectiveness of
aerosolized KL4 surfactant
in a CF population. The trial was presented at the 2010 North
American Cystic Fibrosis Conference, and the principle investigator concluded
that aerosolized KL4 surfactant
delivery was feasible to CF patients, was generally safe and well tolerated, was
not associated with serious adverse events (SAEs) and demonstrated evidence of
pharmacologic response via improvement in mucociliary clearance (MCC) versus
patient baseline. Previously, Discovery reported that KL4 surfactant
improved MCC in an established pre-clinical model designed to assess drug effect
on mucociliary clearance.
The U.S.
Orphan Drug Act is intended to assist and encourage companies to develop safe
and effective therapies for the treatment of rare diseases and
disorders. Orphan drug designation in the United States is awarded to
compounds that offer potential therapeutic value in the treatment of rare
diseases, defined as those affecting fewer than 200,000 Americans. If the
company complies with certain FDA specifications and receives marketing approval
for the designated indication, orphan drug designation qualifies the sponsor for
up to seven years of marketing exclusivity, tax credits related to clinical
research, and exemption from the Prescription Drug User Fee Act filing
fees. The Company is also in the process of applying for Orphan
Designation for CF treatment in Europe.
About
Cystic Fibrosis (CF)
CF is a
fatal genetic disease that causes life-threatening lung infections and premature
death. It affects approximately 30,000 patients in the United States and nearly
70,000 worldwide. It is one of the most common genetic disorders in
the United States. To date, treatment of pulmonary conditions in CF
primarily includes antibiotics to address lung infection and airway clearance
therapies to break down and remove mucus. Despite advances in
research and medical therapies, the predicted median age of survival for
patients with CF in the United States is currently 37 years.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing KL4 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 and 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 deep 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
Discovery Labs’ pre-clinical and clinical research and development activities,
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. Except as otherwise required by law, Discovery Labs
undertakes no obligation to update or revise any forward-looking
statements.
Contact
Information:
Media
relations:
Michelle
Linn, Linnden Communications
508-362-3087
Investor
relations:
John G.
Cooper, President and Chief Financial Officer
215-488-9490