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
September
28, 2006
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
September 28, 2006, Discovery Laboratories, Inc. (the “Company”) issued a press
release to announce that it has filed a briefing package and requested a meeting
with the U.S. Food and Drug Administration (the “FDA”) to gain the FDA’s
agreement on the appropriate path towards Surfaxin®
(lucinactant) approval for the prevention of Respiratory Distress Syndrome
in
premature infants. The press release also provides an update on the
manufacturing activities. The press release, dated September 28, 2006, is filed
as Exhibit 99.1 to this report and is incorporated herein by
reference.
Item
9.01. Financial
Statements and Exhibits.
|
(d)
|
Exhibits
|
|
99.1
|
Press
release, dated September 28, 2006.
|
Cautionary
Note Regarding Forward-looking Statements:
To
the
extent that statements in this Current Report on Form 8-K are not strictly
historical, including statements as to business strategy, outlook, objectives,
future milestones, plans, intentions, goals, future financial conditions, future
collaboration agreements, the success of the Company’s product development or
otherwise as to future events, such statements are forward-looking, and are
made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. The forward-looking statements contained in this Current
Report are subject to certain risks and uncertainties that could cause actual
results to differ materially from the statements made. Such risks and others
are
further described in the Company's 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.
2
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/ Robert J. Capetola | |
|
Robert J. Capetola, Ph.D |
||
| President and Chief Executive Officer | ||
Date:
September 28, 2006
3
 |
Exhibit
99.1
Discovery
Labs Updates Progress on Manufacturing Remediation and
Surfaxin®
FDA Regulatory Matters
Files
Briefing Package and Requests Meeting with FDA to Gain Clarity on
Key
Requirements Leading to Surfaxin Approval
Warrington,
PA - September 28, 2006, -- Discovery Laboratories, Inc.
(Nasdaq:DSCO),
today
has formally filed a briefing package and requested a meeting with the FDA
to
gain the Agency’s agreement on the appropriate path towards Surfaxin®
(lucinactant) approval for the prevention of Respiratory Distress Syndrome
(RDS)
in premature infants. The package covers certain key Chemistry, Manufacturing
and Controls (CMC) matters contained in the April 2006 Surfaxin Approvable
Letter received from the FDA, as well as detailing Discovery’s comprehensive
investigation and remediation of the process validation failure. Discovery
anticipates that the meeting will occur in the fourth quarter of 2006.
Importantly,
Discovery’s investigation into the April 2006 Surfaxin process validation
stability failure has determined a most probable root cause. Remediation
activities have been implemented that are consistent with the manufacturing
procedures that produced the Surfaxin lots used in Discovery’s highly successful
Phase 3 clinical studies, which demonstrated that Surfaxin was significantly
more effective in the prevention of RDS and also improved survival versus
comparator surfactants. Discovery remains on-track to commence the manufacture
of new process validation lots in the fourth quarter of 2006.
The
Approvable Letter contains CMC issues that predominantly relate to active
ingredient and drug product specifications and related controls. Notably, the
Approvable Letter did not indicate the need for additional clinical trials.
To
address the process validation stability failure Discovery conducted a
comprehensive investigation focused on analysis of manufacturing processes;
equipment and process validation; manufacturing components; drug substances;
review and assessment of out-of-specification and deviation reports; analytical
methods and method validation; and change control documentation. Discovery
has
been able, through the investigative process, to simultaneously address certain
CMC issues.
Discovery
has successfully manufactured numerous lots of Surfaxin that achieved a desired
stability profile. In December 2005 Discovery acquired and took control of
the
Totowa, NJ manufacturing operations of Laureate Pharma, Inc. Concurrently,
pharmaceutical executives with extensive manufacturing, regulatory, and quality
assurance expertise joined Discovery’s senior management team. The expertise of
these executives coupled with the remediation outcomes is expected to enhance
pharmaceutical development across Discovery’s broad SRT product
pipeline.
Per
FDA
guidance, the Agency should notify Discovery of the meeting date within 14
days
of receipt of Discovery’s request and briefing package, and such meetings should
occur within 75 days of the written request. While significant progress in
Discovery’s manufacturing investigation and remediation has been made, the
investigation is ongoing and when completed, Discovery intends to finalize
a
comprehensive investigation report and corrective action plan.
DISCLOSURE
NOTICE: The information in this press release includes certain “forward-looking”
statements relating to the potential results of Discovery’s ongoing
manufacturing investigation and remediation and FDA approval of its NDA for
Surfaxin. Although Discovery is encouraged by the findings of its investigation
to date, the investigation is ongoing and the final results could vary
materially from the indications obtained to date. Discovery currently believes
that it will succeed in submitting its complete response to the second
Approvable Letter, subject to the risks that the final investigation report
may
identify unforeseen problems that have not yet been discovered. The reader
of
this release should understand that the failure to satisfactorily investigate
and remediate Discovery’s manufacturing issues could result in significant
delays and prevent the approval of Surfaxin or other Discovery
products.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing Surfactant Replacement
Therapies (SRT) for respiratory diseases. Surfactants are produced naturally
in
the lungs and are essential for breathing. Discovery’s technology produces a
precision-engineered surfactant that is designed to closely mimic the essential
properties of natural human lung surfactant. Discovery believes that its
proprietary SRT pipeline has the potential to advance respiratory medicine
and
address a variety of respiratory diseases affecting premature infants, children
and adults.
Discovery’s
lead product candidate, Surfaxin, is the subject of an Approvable Letter from
the FDA for the prevention of Respiratory Distress Syndrome in premature
infants. Surfaxin® is also being developed for the prevention and treatment of
Bronchopulmonary Dysplasia in premature infants. Aerosurf™, Discovery’s
aerosolized SRT, is being developed initially to treat premature infants
suffering from respiratory disorders and is intended to obviate the need for
intubation and conventional mechanical ventilation. Discovery’s SRT pipeline
also includes programs addressing Acute Lung Injury, Acute Respiratory Failure,
Cystic Fibrosis, Acute Respiratory Distress Syndrome, and other respiratory
conditions.
To
the extent that statements in this press release are not strictly historical,
including statements as to business strategy, outlook, objectives, future
milestones, plans, intentions, goals, future financial conditions, future
collaboration agreements, the success of Discovery’s product development, events
conditioned on stockholder or other approval, or otherwise as to future events,
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. Among
the factors which could affect Discovery’s actual results and could cause
results to differ from those contained in these forward-looking statements
are
the risk that financial conditions may change, risks relating to the progress
of
Discovery’s research and development, the risk that Discovery will not be able
to raise additional capital or enter into additional collaboration agreements
(including strategic alliances for aerosol and Surfactant Replacement
Therapies), the risk that Discovery will not be able to develop or otherwise
provide for a successful sales and marketing organization in a timely manner,
if
at all, the risk that approval by the FDA or other health regulatory authorities
of any applications filed by Discovery may be withheld, delayed and/or limited
by indications or other label limitations, the risk that any such regulatory
authority will not approve the marketing and sale of a drug product even after
acceptance of an application filed by Discovery for any such drug product,
risks
that the Chemistry, Manufacturing and Controls (CMC) section of
Discovery’s
New Drug Application will not satisfy the FDA, risk in the FDA or other
regulatory agency review process generally, risks relating to the ability of
Discovery or Discovery’s third party contract manufacturers and development
partners to manufacture or provide Discovery with adequate supplies of drug
substance, drug products and expertise for completion of any of Discovery’s
clinical studies, risks relating to drug manufacturing by Discovery, risks
relating to the integration of manufacturing operations into Discovery’s
existing operations, other risks relating to the lack of adequate supplies
of
drug substance and drug product for completion of any of Discovery’s clinical
studies, risks relating to the ability of Discovery and its collaborators to
develop, manufacture and successfully commercialize products that combine
Discovery’s drug products with innovative aerosolization technologies, risks
relating to the significant, time-consuming and costly research, development,
pre-clinical studies, clinical testing and regulatory approval for any products
that we may develop independently or in connection with Discovery’s
collaboration arrangements, and risks relating to the development of competing
therapies and/or technologies by other companies. Companies in the
pharmaceutical and biotechnology industries have suffered significant setbacks
in advanced clinical trials, even after obtaining promising earlier trial
results. Data obtained from tests are susceptible to varying interpretations,
which may delay, limit or prevent regulatory approval. Those associated risks
and others are further described in Discovery’s 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.
For
more information, please visit our corporate website at www.Discoverylabs.com.
Company
Contact:
Lisa
Caperelli, Investor Relations
215-488-9413