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
September
8, 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
September 8, 2005, Discovery Laboratories, Inc., a Delaware corporation (the
“Company”) announced that it has completed a pilot Phase 2 feasibility study of
Aerosurf™, the Company’s precision-engineered aerosolized Surfactant Replacement
Therapy (SRT) administered via nasal continuous positive airway pressure
(nCPAP)
intended to treat premature infants at risk for respiratory distress syndrome
(RDS).
This
initial pilot trial was not designed to demonstrate efficacy outcomes. The
Company issued a press release providing this information on September 8,
2005.
The full text of the press release is set forth in Exhibit 99.1 to this Current
Report on Form 8-K.
Item
9.01. Financial
Statements, Pro Forma Financial Statements and
Exhibits
(c) Exhibits:
|
99.1
|
Press
Release dated September 8, 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.
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: September 9, 2005 | ||
Exhibit
99.1
Discovery
Labs Completes Pilot Phase 2 Study of Investigational Drug
Aerosurf™,
its
Aerosolized Surfactant Delivered via Nasal CPAP
Warrington,
PA - September 8, 2005 - Discovery
Laboratories, Inc. (Nasdaq: DSCO) has completed its first pilot Phase 2
feasibility study of Aerosurf™, the Company’s precision-engineered aerosolized
Surfactant Replacement Therapy (SRT) administered via nasal continuous positive
airway pressure (nCPAP) intended to treat premature infants at risk for
respiratory distress syndrome (RDS). This pilot clinical trial serves as the
first step in the development of a revolutionary technology that has the
potential to treat infants with a wide array of respiratory failures who
typically would require mechanical ventilation. Discovery
will hold a conference call today at 10:00 AM EDT. The call in number is
866-332-5218.
The
pilot
Phase 2 clinical trial was an open label, multicenter study to evaluate the
feasibility, safety and tolerability of Aerosurf delivered via nCPAP for the
prevention of RDS in premature infants. The trial was conducted at four centers
in the United States and enrolled 17 infants with a gestational age ranging
between 28-32 weeks and a mean birth weight of 1460 grams. Aerosurf
was
administered
to infants within 30 minutes of birth for a three hour duration. Retreatments
were allowed if infants met certain medical criteria.
The
study
showed that it is feasible to deliver Aerosurf via nCPAP and the treatment
was
generally safe and well tolerated. This initial pilot trial was not designed
to
demonstrate efficacy outcomes. Key observations included:
| · |
All
infants survived; none had lung airleaks or developed necrotizing
enterocolitis (an inflammatory gastrointestinal disease) and one developed
a low-grade intraventricular hemorrhage.
|
| · |
Fifteen
of the seventeen infants had no evidence of bronchopulmonary dysplasia
(commonly known as BPD, a chronic lung disease) at Day
28.
|
| · |
Four
infants had evidence of RDS at 24 hours with three requiring intubation
with mechanical ventilation due to complications of their clinical
course.
Two additional infants required intubation with mechanical ventilation
without evidence of RDS at 24 hours.
|
| · |
Peri-dosing
events included apnea and desaturation but without clinically important
sequelae.
|
“We
are
very encouraged with the outcomes of our first pilot study with Aerosurf. The
insights gained will allow us to prepare for our next clinical trial,” commented
Robert Segal MD, Senior Vice President and Chief Medical Officer.
“Neonatologists have limited pharmacologic options to treat serious respiratory
diseases outside of RDS; many of these infants suffer significant morbidity
and
require costly treatments with prolonged hospital stays. No currently available
surfactants have addressed these unmet needs. Aerosurf represents a novel
therapeutic approach for the potential treatment of infants with various
respiratory diseases.”
Neonatal
Respiratory Failures
Serious
respiratory problems are some of the most prevalent medical issues facing
premature infants in Neonatal Intensive Care Units. There are approximately
1.5
million premature infants born annually worldwide at risk for respiratory
problems associated with surfactant dysfunction. The majority of these infants
are usually at a birth weight greater than 1250 grams, and neonatologists
generally try to avoid mechanically ventilating these patients because doing
so
requires intubation (the invasive process of inserting a breathing tube down
the
trachea). This reluctance is due to the risks associated with intubation and
the
need for paralytic agents and sedation. As a result, many neonatologists will
only intubate in cases of severe respiratory disease, where the benefits clearly
outweigh the risks. The neonatal medical community recognizes the potential
utility of a non-invasive method of delivering SRT to treat premature infants
suffering from respiratory disorders including RDS, BPD, bronchiolitis, acute
hypoxia, pneumonia, and transient tachypnea.
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/252908
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. The replay number to hear the
conference call is 800-642-1687 or 706-645-9291. The passcode is
9329269.
Aerosurf
is an investigational drug that has not been approved by the U.S. FDA or any
other world health regulatory authorities.
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 address respiratory
diseases where there are few or no approved therapies available.
Discovery’s
SRT pipeline is initially focused on the most significant respiratory conditions
prevalent in the neonatal intensive care unit. The Company’s lead product,
Surfaxin, for the prevention of Respiratory Distress Syndrome (RDS) in premature
infants, has received an Approvable Letter from the FDA and is under review
for
approval in Europe by the EMEA. In addition, the Company is developing Surfaxin
for the treatment of Bronchopulmonary Dysplasia (BPD) in premature infants
and
Aerosurf, aerosolized SRT administered through nasal continuous positive airway
pressure (nCPAP), for neonatal respiratory failures.
To
address the various respiratory conditions affecting pediatric, young adult
and
adult patients in the critical care and other hospital settings, Discovery
is
conducting a Phase 2 clinical trial to address Acute Respiratory Distress
Syndrome (ARDS) in adults, and is also developing aerosol formulations of SRT
to
address Acute Lung Injury (ALI), asthma, COPD, 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, 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