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
August
19, 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
August
19, 2005, Discovery Laboratories, Inc., a Delaware corporation (the “Company”)
announced that it had received formal written notification from the U.S.
Food
and Drug Administration (the “FDA”), following its review of the Company’s
previously submitted Response Letter, outlining items that need to be addressed
in order for the FDA to deem the response complete. The Company’s Response
Letter to the FDA’s Approvable Letter for Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants was submitted to the FDA on July 29, 2005. The Company
issued
a press release providing this information on August 19, 2005. The full text
of
the press release is set forth in Exhibit 99.1 to this Current Report on
Form
8-K.
On
August
19, 2005, the Company held a conference call to provide an update of the
status
of its response to the FDA’s Approvable Letter. The Company also provided
clarification of the FDA regulatory process for Surfaxin’s approval. The Company
anticipates that in October 2005 it will submit its response (as an amendment
to
its Response Letter) to the items outlined by the FDA as requiring further
clarification or additional information. The FDA has fourteen days from the
date
of that submission to respond to the Company as to whether that amendment,
together with the previously submitted Response Letter, constitutes a complete
response to its Approvable Letter. Should the Company’s Response Letter, as
amended, be deemed complete, the FDA has a six month target to complete its
review of the Company’s NDA for Surfaxin. Should the Company’s October
submission be considered by the FDA to complete the Company’s Response Letter
and the FDA meets its review cycle target, the Company anticipates that the
FDA
will approve the Surfaxin NDA in April 2006 with commercial launch to occur
in
the second quarter of 2006.
The
Company also adjusted its previously communicated timelines for the potential
European approval of Surfaxin by the European Medicines Evaluation Agency
(EMEA)
by announcing such approval is now anticipated in the second quarter of 2006.
In
addition, the Company provided adjustments to its previously reported estimates
of quarterly net decreases in cash, cash equivalents, restricted cash and
marketable securities (collectively, “Cash”) for the third and fourth quarters
of 2005. The Company is now projecting net decreases in Cash of $10 million
and
$12 to $12.5 million for the third and fourth quarters of 2005,
respectively.
Item
9.01. Financial
Statements, Pro Forma Financial Statements and
Exhibits
(c) Exhibits:
|
99.1
|
Press
Release dated August 19, 2005.
|
2
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 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: August 19, 2005 | ||
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Exhibit
99.1
Discovery
Labs Provides Update on Status of Response to FDA Approvable Letter for
Surfaxin®
Warrington,
PA, August 19, 2005 — Discovery Laboratories, Inc. (Nasdaq: DSCO) has received
formal written notification from the U.S. Food and Drug Administration (FDA),
following its review of the Company’s previously submitted Response Letter,
outlining select items that need to be addressed in order for the FDA to deem
the response complete. The Company’s Response Letter to the FDA’s Approvable
Letter for Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants was previously submitted on July 29, 2005.
In
its
written notification, the FDA outlined twelve items, centered on chemistry
and
manufacturing, that require further clarification or additional information
to
support the Company’s comprehensive response. These items are not related to the
quality of the Surfaxin clinical trials or their results. Additionally, the
items do not raise any new issues related to the Company’s contract drug product
manufacturer, Laureate Pharma, Inc. The Company is in the process of addressing
these items and anticipates submitting its response to the FDA in October 2005.
The approval of Surfaxin is now anticipated in April 2006 with commercial launch
to occur in the second quarter of 2006.
Discovery
will hold a conference call today at 10:00 AM EDT to further discuss in greater
detail 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/251016
and
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.
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. 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.
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DISCLOSURE
NOTICE: The information in this press release includes certain “forward-looking”
statements relating to the timing of FDA matters relating to Discovery’s NDA for
Surfaxin for RDS, which assume that all of the conditions in the Approvable
Letter are timely satisfied. Any statements contained in this press release
that
do not describe historical facts are forward-looking statements that involve
risks and uncertainties that could cause actual results to differ materially
from those discussed in such forward-looking statements. Such risks and
uncertainties include the following: uncertainties relating to Discovery Labs’
ability to successfully address the comments and concerns of the FDA that may
be
raised during its review process for the Surfaxin NDA; the timing of FDA actions
regarding Surfaxin, including the timing of its review of the supporting data
or
the additional details submitted in relation thereto; the outcome of FDA actions
in response to the submissions, including the possibility that the FDA will
not
consider the submissions complete or that the FDA will require additional
information in support of the submissions; the possibility that even if the
response is deemed complete by the FDA, the FDA could respond to these
submissions by issuing an additional approvable letter with additional
conditions for approval or the FDA could issue a not approvable letter; the
ability to resolve final labeling for Surfaxin with the FDA; uncertainties
regarding market acceptance of Surfaxin; uncertainties relating to third-party
reimbursements; uncertainties relating to Discovery Labs’ ability to continue to
operate at commercial scale in compliance with FDA regulations and other
applicable manufacturing requirements; uncertainties relating to patents and
proprietary rights; issues previously raised by earlier FDA inspections of
the
Totowa, NJ facility of Laureate Pharma, Inc. (Laureate), Discovery’s contract
manufacturer for Surfaxin, and other risks identified in Discovery Labs’
Securities and Exchange Commission filings. Many
factors could cause the resolution of those or other issues to differ materially
from Discovery’s forward-looking statements, including that the timing, scope
and duration of a resolution of the issues related to the Approvable Letter
will
depend on the ability of Discovery (and
Laureate) to assure the FDA of the quality and reliability of its basic quality
controls, process assurances and documentation requirements that support the
commercial production manufacturing process under applicable cGMPs. The reader
of this release should understand that the failure to reach resolution of any
issues could result in delays in ultimate approval of Discovery’s potential
products beyond the first quarter of 2006.
Discovery
Labs further cautions readers not to place undue reliance on any forward-looking
statements which speak only as of the date they are made. Discovery Labs
disclaims any obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or circumstances
on
which any such statements may be based, or that may affect the likelihood that
actual results will differ from those set forth in the forward-looking
statements.
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 Failures in premature infants, severe asthma in adults, and Meconium
Aspiration Syndrome (MAS) in full-term infants.
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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, 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:
John
G.
Cooper, EVP and CFO
215-488-9490
Lisa
Caperelli, Investor Relations
215-488-9413
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