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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
June
27, 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:
[
] Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[
] Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[
] Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
[
] 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
June
27, 2006, Discovery Laboratories, Inc. (the “Company”) issued a press release
reporting progress on its ongoing investigation into and remediation efforts
for
the April 2006 process validation stability failure related to its
Surfaxin®
(lucinactant) New Drug Application. The press release, dated June 27, 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 June 27, 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:
June 27, 2006
3
Exhibit
99.1
Discovery
Labs Reports Progress on its Surfactant Manufacturing
Remediation
Warrington,
PA — June 27, 2006— Discovery Laboratories, Inc. (Nasdaq:
DSCO)
today is
reporting progress on its ongoing investigation into and remediation efforts
for
the April 2006 process validation stability failure related to its
Surfaxin®
(lucinactant) New Drug Application (NDA), including the attainment of some
important investigative milestones. At this time, although the overall
investigation is not complete, Discovery is optimistic that appropriate remedial
actions can be successfully implemented, providing a path to potential approval
of Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants in the United States.
Manufacturing
Investigative Milestones and Next Steps
The
comprehensive investigation was implemented immediately following the April
2006
stability failure of Surfaxin process validation that supported Discovery’s NDA.
The investigation is being conducted in compliance with FDA current good
manufacturing practices (cGMP) requirements and covers analysis of manufacturing
processes; equipment and process validation; manufacturing components, drug
substances and excipient manufacturers; review and assessment of
out-of-specification and deviation reports; analytical methods and method
validation; and change control documentation. The investigation will culminate
in a comprehensive investigation report and a corrective and preventative action
(CAPA) plan.
The
investigation is ongoing and, at this time, it is not possible to anticipate
or
predict with certainty the timing or results of the investigation. Discovery
reports the following progress to date:
| · |
Discovery
recently manufactured two investigation batches of Surfaxin that have
passed all of the critical release specification assays, with the
remaining release analytical procedures and stability monitoring ongoing.
These investigation batches are intended to assess the impact of the
investigative observations and will provide significant supportive
data to
the investigation report and the CAPA plan. These investigation batches
are not designated as process validation
batches.
|
| · |
Discovery’s
data and information gathering phase of the investigation is nearly
complete. These data will support the investigation report and the
CAPA
plan. After a CAPA plan has been implemented, Discovery will meet with
the
FDA to clarify the issues identified in the second Approvable Letter
and
discuss Discovery’s plan to manufacture new process validation batches. It
is Discovery’s goal to meet with the FDA and manufacture new process
validation batches in the fourth quarter of
2006.
|
| · |
Discovery
has been able, through the investigative process, to simultaneously
address certain issues associated with the second Approvable Letter
received from the FDA. Discovery believes that resolution of the
manufacturing issues and implementation of a CAPA plan will also resolve
a
number of issues previously raised by the FDA in the second Approvable
Letter.
|
In
April
2006, Discovery received a second Approvable Letter from the FDA relating to
its
NDA for Surfaxin for RDS in premature infants. Issues contained in the second
Approvable Letter primarily focused on the Chemistry, Manufacturing and Controls
section of the NDA and product labeling. Most notably, the FDA did not require
any additional clinical trials.
Over
the
years, Discovery has successfully manufactured numerous batches of Surfaxin,
representing thousands of vials that achieved the desired stability profile.
These batches included those used in Discovery’s highly successful Phase 3
clinical studies which demonstrate that Surfaxin was significantly more
effective in the prevention of RDS and also improved survival (continuing
through at least one year of life) and other outcomes versus comparator
surfactants. Discovery is conducting its investigation, in part, with reference
to the manufacturing procedures that were used to produce those Surfaxin
batches.
The
investigation is led by Charles F. Katzer, Senior Vice President of
Manufacturing Operations, and Gerald J. Orehostky, Vice President of Quality
Operations. Mr. Katzer joined Discovery in January 2006 to oversee Discovery’s
newly-purchased manufacturing facility in Totowa, NJ. Mr. Katzer has more than
30 years of broad functional experience in all aspects of manufacturing
operations with major pharmaceutical and biopharmaceutical companies. He has
extensive expertise in the sterile manufacture of liquids, injectables and
aerosol dosage forms, product and process development, and process validation.
Mr. Orehostky has approximately 20 years of diverse quality assurance and
regulatory compliance experience with global pharmaceutical, biopharmaceutical
and medical device companies.
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 preliminary findings of its
investigation, the investigation is ongoing, more work remains to be done and
the final results could vary materially from the preliminary indications
obtained to date. Discovery currently believes that it will succeed in
implementing a CAPA plan and 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 proprietary 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 pulmonary surfactant platform has the potential to address
a
variety of respiratory diseases where there are few or no approved therapies
available.
Discovery’s
lead product, Surfaxin, has received two Approvable Letters from the FDA for
the
prevention of Respiratory Distress Syndrome (RDS) in premature infants. In
addition, Discovery recently concluded patient enrollment for its Phase 2
clinical trial of Surfaxin for premature infants for the prevention and
treatment of Bronchopulmonary Dysplasia (BPD).
Discovery
is also developing Aerosurf, its proprietary SRT administered in aerosolized
form, for the treatment of premature infants with multiple respiratory
disorders. Discovery is preparing to initiate Phase 2 clinical studies with
Aerosurf administered through nasal continuous positive airway pressure (nCPAP),
potentially obviating the need for intubation and conventional mechanical
ventilation. Discovery is also developing its SRT to potentially address Acute
Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS), cystic fibrosis
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), 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
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, 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 that
Discovery’s CMC 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 and successfully
commercialize products that will combine our 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 our 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
Contacts:
John
G.
Cooper, Executive Vice President and Chief Financial Officer
215-488-9490