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
July
29, 2005
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
July
29, 2005, Discovery Laboratories, Inc., a Delaware corporation (the “Company”)
announced that it has submitted a response to the Approvable Letter received
from the U.S. Food and Drug Administration (“FDA”) for Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (“RDS”) in
premature infants. The FDA issued the Approvable Letter in February 2005
noting
certain previously reported manufacturing issues from inspections of the
Company’s contract manufacturer Laureate Pharma, Inc. The Company issued a press
release providing this update on July 29, 2005. The full text of the press
release is set forth in Exhibit 99.1.
Item
9.01 Financial
Statements, Pro Forma Financial Statements and
Exhibits
| (c) | Exhibits: |
|
99.1
|
Press
Release dated July 29, 2005.
|
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 | |
|
Name: Robert J. Capetola, Ph.D. |
||
| Title: President and Chief Executive Officer | ||
| Date: July 29, 2005 | ||
3
Exhibit
99.1
Discovery
Labs Submits Response to FDA Approvable Letter for SurfaxinÒ
for RDS
in Premature Infants
Warrington,
PA, July 29, 2005 — Discovery Laboratories, Inc. (Nasdaq: DSCO), today announced
that it has submitted its response to the Approvable Letter received from
the
U.S. Food and Drug Administration (FDA) for Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. The Company believes that the response addresses the comments
noted in the Approvable Letter by providing the FDA with the information
necessary to complete its review of the Surfaxin New Drug Application (NDA)
within six months.
In
February 2005, the FDA issued an Approvable Letter indicating that it is
prepared to approve the NDA when issues noted in the letter are adequately
addressed. Most importantly, the FDA is not requiring additional preclinical
or
clinical studies. The Approvable Letter addressed certain labeling, chemistry,
and manufacturing issues. With respect to Discovery’s contract manufacturer,
Laureate Pharma, Inc. (Laureate), the FDA previously issued a Form 483, citing
inspectional observations related to compliance with current Good Manufacturing
Practices (cGMPs) and other processes to be used for commercial production
of
the product. The general theme of the observations related to basic quality
controls, process assurances and documentation requirements that support
the
commercial production process.
Christopher
J. Schaber, Ph.D., Executive Vice President and Chief Operating Officer of
Discovery commented, “Discovery and Laureate have worked aggressively to
implement improved quality systems and documentation controls. We believe
these
efforts support our response to the FDA Approvable Letter and prepare us
for the
FDA’s reinspection of Laureate’s Totowa facility. We are confident that these
actions bring Surfaxin, the first precision-engineered Surfactant Replacement
Therapy, closer to the neonatal community as we anticipate approval and
commercial launch in the first quarter of 2006.”
Surfactants
are substances that are produced naturally in the lungs and are essential
to the
lungs’ ability to absorb oxygen and to maintain proper airflow through the
respiratory system. Premature babies are born with a lack of natural surfactant
in their lungs. Without surfactant, the air sacs in the lungs collapse and
are
unable to absorb sufficient oxygen resulting in 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 for the animal-derived and non-protein containing
synthetic surfactants. Discovery’s Surfaxin has recently received an Approvable
Letter from the FDA for the prevention of RDS in premature infants and is
pending approval.
Discovery
will hold a conference call on Tuesday, August 2, 2005 at 10:00 AM EDT. 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/247473
or
www.DiscoveryLabs.com. It is recommended that participants log onto one of
these
sites at least 15 minutes prior to the call. The Internet broadcast will
be
available for up to 30 days after the call at both website
addresses.
DISCLOSURE
NOTICE: The information in this press release includes certain “forward-looking”
statements relating to the timing of FDA approval of Discovery’s NDA for
Surfaxin for RDS, which assume that all of the conditions in the Approvable
Letter are timely satisfied. These conditions include, without limitation,
issues previously raised by earlier FDA inspections of the Totowa, NJ facility
of Laureate Pharma, Inc. (Laureate), Discovery’s contract manufacturer for
Surfaxin.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing its proprietary
surfactant technology as 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 through its technology, pulmonary
surfactants have the potential, for the first time, to be developed into
a
series of respiratory therapies for patients in the neonatal intensive care
unit, critical care unit and other hospital settings, where there are few
or no
approved therapies available.
Discovery
has received an Approvable Letter from the FDA for Surfaxin, the Company’s lead
product, for the prevention of Respiratory Distress Syndrome (RDS) in premature
infants, and has filed a Marketing Authorization Application with the EMEA
for
clearance to market Surfaxin in Europe. Discovery is also conducting various
clinical programs to address Acute Respiratory Distress Syndrome (ARDS) in
adults, Bronchopulmonary Dysplasia (BPD) in premature infants, Neonatal
Respiratory Disorders in premature infants, severe asthma in adults, and
Meconium Aspiration Syndrome (MAS) in full-term infants.
More
information about Discovery is available on the Company's Web site 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, 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 our aerosol and Surfactant Replacement
Therapies), risk that Discovery will not be able to develop a successful
sales
and marketing organization in a timely manner, if at all, risk that Discovery’s
internal sales and marketing organization will not succeed in developing
market
awareness of Discovery’s products, risk that Discovery’s internal sales and
marketing organization will not be able to attract or maintain qualified
personnel, risk of delay in the FDA’s or other health regulatory authorities’
approval of any applications filed by Discovery, risks 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
relating to the ability of Discovery’s third party contract manufacturers to
provide Discovery with adequate supplies of drug substance and drug products
for
completion of any of Discovery’s clinical studies, other risks relating to the
lack of adequate supplies of drug substance and drug product for completion
of
any of Discovery’s clinical studies, 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
Contacts:
Lisa
Caperelli, Investor Relations
215-488-9413
John
G.
Cooper, EVP and CFO
215-488-9490