UNITED
STATES
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
April
12, 2006
Date
of
Report (Date of earliest event reported)
Discovery
Laboratories, Inc.
(Exact
name of Company 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 18976-3622
(Address
of principal executive offices)
(215)
488-9300
(Company'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 Company 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
April
12, 2006, Discovery Laboratories, Inc. (the “Company”) held a conference call to
provide a regulatory update on its lead product, Surfaxin®
for the
prevention of Respiratory Distress Syndrome (RDS) in premature infants, focusing
on its U.S. New Drug Application. The update also provided information with
respect to the outcomes of two recently completed regulatory authority
inspections of the Company’s manufacturing facility, and provided guidance
regarding the Company’s response to such inspections.
European
Medicines Evaluation Agency (EMEA) Inspection Update
In
February 2006, the Medicines and Health Products Regulatory Agency (MHRA)
conducted an on-site inspection of the Company’s manufacturing facility on
behalf of the EMEA. Such on-site inspection is required by the EMEA before
the
grant of a Marketing Authorization. EMEA regulatory guidelines provide that
manufacturing facility inspectional observations are classified into three
categories: “critical,” “major” and “other.” The February 2006 inspectional
observations report contained observations categorized only as “other.”
The
Company responded in writing to all of the EMEA inspectional observations within
14 days of the conclusion of the inspection. The Company has not received any
objections, comments or questions from the EMEA to its responses to date. Since
the timeline, per EMEA guidance, for providing any such comments has expired,
the Company considers the EMEA site inspection process satisfactorily
completed.
Food
and Drug Administration (FDA) Inspection Update
The
FDA
concluded a three-week re-inspection of the Company’s manufacturing facility on
April 7, 2006. The FDA had previously conducted a pre-approval inspection of
the
facility in January 2005, at which time the FDA had certain observations
concerning the facility’s compliance with current Good Manufacturing Practices
(cGMPs). The inspection observations at that time were associated primarily
with
basic quality controls, process assurances and documentation requirements to
support the commercial production process, to which the Company responded by
implementing an extensive cGMP corrective action plan, which also included
the
revalidation of the media and process validation runs.
The
focus
of the FDA re-inspection centered on the corrective actions to the Form FDA-483
issued in January 2005, as well as related manufacturing and quality operations,
systems and controls. The FDA issued an inspectional observations report (Form
FDA-483) citing certain observations related predominantly to the clarification
of procedures, documentation and preventative maintenance. The report did not
note a requirement of re-inspection of the facility. The Company expects to
submit its response to a majority of the Form FDA-483 items within the next
two
weeks.
One
item
noted on the inspection report relates to certain drug product specification
issues cited in the second Approvable Letter the Company received on April
5,
2006. The Company plans on responding to this inspectional item in its complete
response to the second Approvable Letter. The Company believes that its
satisfactory response to all of the observations contained in the re-inspection
report will preclude the need for re-inspection of the manufacturing facility
by
the FDA prior to approval. However, in accordance with FDA practice, the agency
may re-inspect the facility at any time.
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Second
Approvable Letter
The
Company’s conference call also outlined proposed further steps towards gaining
clarity with respect to issues cited by the FDA in its second Approvable Letter
and to the course of events leading to a potential approval of Surfaxin for
the
prevention of RDS in premature infants. In accordance with FDA procedural
guidelines, the Company must submit a formal written request for a meeting
with
the FDA to which the agency must respond within 14 days of receipt of such
request, and the meeting must occur within 75 days of the written request.
The
Company expects the meeting to be classified as a Type C Meeting whose purpose
is to clarify the issues outlined in the Approvable Letter and allow the Company
to file a complete response to the noted items.
The
Company is in the process of preparing a detailed informational package which
will establish the agenda for the meeting, and will be submitted to the FDA
in
advance of such meeting. The Company is positioning its activities to prepare
and submit such informational package and the written meeting request in
sufficient time for the meeting to potentially occur in mid- to late June of
this year.
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.
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Company 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, Ph.D.
|
|
|
|
||
|
Robert
J. Capetola, Ph.D.
President
and Chief Executive Officer
|
||
Date:
April 18, 2006
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