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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
January
22, 2007
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
January 22, 2007, Discovery Laboratories, Inc. (the “Company”) announced that it
received guidance from the U.S. Food and Drug Administration (“FDA”) regarding
the key remaining steps necessary for potential approval of Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (“RDS”) in
premature infants. The Company had previously filed a briefing package with
the
FDA in preparation for the meeting on December 21, 2006. The newly received
guidance primarily indicates that the defined pathway to the potential approval
of Surfaxin does not require additional clinical trials and that the shelf-life
for Surfaxin will be determined based upon comparative stability data from
historical Surfaxin batches (including previously manufactured clinical,
technology transfer, and investigational batches), as well as newly manufactured
process validation batches.
As
previously disclosed, the Company received a second Approvable Letter from
the
FDA in April 2006, in which the FDA requested certain information primarily
focused on the Chemistry, Manufacturing and Controls section of the Company‘s
New Drug Application (“NDA”) for Surfaxin. Based upon the recent FDA guidance,
the Company anticipates filing its formal response to the April 2006 Approvable
Letter in September or October 2007. Should the FDA deem such response complete,
the agency has a six-month target to complete its review of the NDA. The
press
release, dated January 22, 2007, 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 January 22, 2007.
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:
January 22, 2007
3
Exhibit
99.1
Discovery
Labs and FDA Reach Clarity on Path Towards Surfaxin®
RDS Approval
Conference
Call Scheduled for Today at 11:00 AM
Warrington,
PA — January 22, 2007 — Discovery Laboratories, Inc. (Nasdaq: DSCO)
announced
today that it has received guidance from the U.S. Food and Drug Administration
(FDA) in a recent meeting regarding the key remaining steps necessary for
potential approval of Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. The guidance provides the clarity and the defined pathway
that Discovery believes is necessary to address key remaining issues identified
in the April 2006 FDA Approvable Letter. Discovery anticipates filing its formal
response to the Approvable Letter in September or October 2007, followed by
a
six-month review cycle by the FDA for potential approval of its New Drug
Application (NDA) for Surfaxin.
The
guidance was based on a face-to-face meeting with the FDA on December 21, 2006
as well as the FDA’s review of the meeting briefing package submitted by
Discovery on September 28, 2006.
| · |
The
defined pathway to potential Surfaxin approval does not include a
requirement for additional clinical
trials.
|
| · |
The
April 2006 Approvable Letter primarily focused on the Chemistry,
Manufacturing and Controls (CMC) section of the Surfaxin NDA and requested
additional information predominantly involving drug product specifications
and related controls. With the clarity gained at the FDA meeting,
Discovery expects to provide all of the necessary additional information
in its formal response to the Approvable Letter.
|
| · |
Discovery
provided information to the FDA regarding its comprehensive investigation
and remediation of the April 2006 Surfaxin process validation stability
failure including the identification of a most probable root cause.
The
comprehensive investigation focused on analysis of manufacturing
processes; analytical methods and method validation; and active
pharmaceutical ingredient suppliers.
|
Consistent
with Discovery’s proposal included in the FDA meeting briefing package,
Discovery is planning to initiate the manufacture of new Surfaxin process
validation batches this week and will submit six months of related stability
data in its forthcoming formal response to the Approvable Letter. Additionally,
the FDA indicated that Surfaxin shelf-life will be determined based upon
comparative stability data from historical Surfaxin batches, including
previously manufactured clinical, technology transfer, and investigational
batches, as well as the new process validation batches.
Robert
J.
Capetola, Ph.D., President and Chief Executive Officer of Discovery, commented,
“The encouraging outcome of this important FDA meeting is a reflection of the
leadership and efforts of our team of regulatory, manufacturing and quality
executives. This executive team is also responsible for improving and enhancing
the manufacturing operations that we acquired from our then contract
manufacturer. With the clarity gained from the FDA meeting, the top priorities
now are completing the necessary work to submit our response to the FDA for
Surfaxin approval, and advancing Aerosurf™, our aerosolized surfactant therapy,
into Phase 2 clinical trials.”
Conference
Call Details
Discovery
will hold a conference call today at 11:00 AM EST to further discuss the
foregoing. The call in number is 866-332-5218. The international call in number
is 706-679-3237. This audio webcast will be available to shareholders and
interested parties through a live broadcast on the Internet at http://audioevent.mshow.com/319609 and
www.discoverylabs.com.
The
replay number to hear the conference call is 800-642-1687 or 706-645-9291.
The
passcode is 6538198.
About
Surfaxin®
and
RDS
Surfaxin
is a precision-engineered, peptide-containing, synthetic surfactant that is
designed to closely mimic the function of natural human lung surfactant and
represents a potential alternative to animal-derived surfactants. Surfaxin’s
precision-engineered and non-immunogenic nature allows it to be further
developed as a therapeutic addressing other pulmonary conditions in neonatal
and
pediatric medicine. Data from Discovery’s pivotal, multinational SELECT study
demonstrate that Surfaxin is significantly more effective in the prevention
of
RDS and improved survival (continuing through at least one year of life) and
other outcomes versus comparator surfactants. The SELECT
and STAR (a supportive Phase 3 study) trials, as well as a pooled Phase 3
analysis, have been presented at several international medical meetings and
the
results from the two studies were published in Pediatrics.
RDS
afflicts approximately 120,000 premature infants in the United States each
year,
with a global at-risk population in excess of 500,000 infants. Approximately
75,000 infants are treated annually in the United States with
currently-available surfactant products, all of which are animal-derived.
DISCLOSURE
NOTICE: The information in this press release includes certain “forward-looking”
statements relating to, among other things, the remaining steps necessary for
FDA approval of Surfaxin for the prevention of RDS in premature infants,
including information to be prepared for inclusion in Discovery’s formal
response to the second Approvable Letter and the potential results of
Discovery’s ongoing manufacturing investigation and remediation. Although
Discovery is encouraged by its meeting with the FDA and the findings of its
comprehensive investigation to date, both the development of information for
the
formal response to the second Approvable Letter and the comprehensive
investigation are ongoing and the final results of both these efforts 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, including six months of stability data for the new process
validation batches, within the indicated timeframe, subject, however, to a
variety of risks, including that Discovery may not succeed in developing the
information necessary for the formal response, the new process validation
batches may fail to meet designated stability or other release parameters and
the final comprehensive investigation report may identify unforeseen problems
that have not yet been discovered. The reader of this release should understand
that the failure to develop all necessary information required to respond to
the
second Approvable letter or to satisfactorily investigate and remediate
Discovery’s manufacturing issues could result in significant delays or
additional requirements and potentially 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. For more information, please visit our
corporate website at www.Discoverylabs.com.
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, the success
of Discovery’s product development, 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 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 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.
Company
Contact:
Lisa
Caperelli, Investor Relations
215-488-9413