Unassociated Document
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
26, 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:
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 26, 2006, Discovery Laboratories, Inc. (the “Company”) issued a press
release announcing that the United States Food and Drug Administration has
granted Fast Track designation to the Company’s lead product, Surfaxin®, for the
prevention and treatment of Bronchopulmonary Dysplasia (“BPD”) in premature
infants. Under the FDA Modernization Act of 1997, designation as a Fast Track
product for a new drug means that the FDA has determined that the drug is
intended for the treatment of a serious or life-threatening condition and
demonstrates the potential to address unmet medical needs for such a condition,
and that the FDA will facilitate and expedite the development and review of
the
application for the approval of the product. The Company is currently conducting
a Phase 2 clinical trial to determine the safety and tolerability of
administering Surfaxin as a therapeutic approach for the prevention and
treatment of BPD. Results from this study are expected in 2006. The press
release, dated January 26, 2006, is filed as Exhibit 99.1 to this report and
is
incorporated herein by reference.
Item
9.01. Financial
Statements and Exhibits.
| |
|
99.1
|
Press
release, dated January 26, 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.
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.
| |
|
|
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Discovery
Laboratories, Inc. |
|
|
|
| |
By: |
/s/ Robert
J.
Capetola |
| |
Name:
Robert J. Capetola, Ph.D. |
| |
Title:
President and Chief Executive Officer |
| |
|
| Date: January 30, 2006 |
|
Unassociated Document
Exhibit
99.1
FDA
Grants Discovery Labs’ Surfaxin®
Fast Track Designation for Prevention and Treatment of Bronchopulmonary
Dysplasia
Warrington,
PA — January 26, 2006 — Discovery Laboratories, Inc. (Nasdaq:
DSCO)
announced that the United States Food and Drug Administration (FDA) has granted
Fast Track designation to Discovery’s lead product, Surfaxin®,
for the
prevention and treatment of Bronchopulmonary Dysplasia (BPD, also known as
Chronic Lung Disease) in premature infants.
Under
the
FDA Modernization Act of 1997, designation as a Fast Track product for a new
drug means that the FDA has determined that the drug is intended for the
treatment of a serious or life-threatening condition that demonstrates the
potential to address unmet medical needs for such a condition, and that the
FDA
will facilitate and expedite the development and review of the application
for
the approval of the product.
BPD
is a
costly syndrome affecting premature infants. It is associated with surfactant
deficiency and the prolonged use of mechanical ventilation and oxygen
supplementation. Some 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 Respiratory
Distress Syndrome (RDS). To treat RDS, babies require a surfactant usually
within one hour of birth as well as mechanical ventilation to support the
babies’ respiration. The lack of surfactant and use of mechanical ventilation
may cause chronic injury and scarring of the lungs - resulting in BPD.
Robert
J.
Capetola, Ph.D., President and Chief Executive Officer of Discovery commented,
“The FDA’s decision to grant Fast Track designation to Surfaxin for BPD is
important for the neonatal medical community. Presently there are no approved
drugs for the treatment of BPD. These babies suffer from abnormal lung
development and typically have a need for respiratory assistance spanning from
many months to years. It is estimated that the cost of treating an infant with
BPD in the United States can approach $250,000.”
Surfaxin
has already received an Approvable Letter from the FDA for the prevention of
RDS
in premature infants and anticipates potential approval in April 2006. To
further develop Surfaxin for neonatal respiratory diseases, Discovery is
currently conducting a Phase 2 clinical trial to determine the safety and
tolerability of administering Surfaxin as a therapeutic approach for the
prevention and treatment of BPD. The BPD study design provides that premature
infants receive a treatment regime of up to 5 Surfaxin doses beginning within
the first 3-10 days of life that are in addition to the surfactant they received
on day 1 of life for RDS. The purpose of this study is to determine whether
such
treatment can decrease the proportion of infants on mechanical ventilation
or
oxygen supplementation or decrease the incidence of death or BPD. Results from
this trial are expected in 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. Surfactant treatment options available today are limited
to
FDA approved animal-derived or non-protein containing synthetic products and
are
only approved for RDS. Surfaxin is a precision-engineered, peptide-containing,
synthetic surfactant that is designed to closely mimic the function of natural
human lung surfactant. In clinical trials comparing Surfaxin to the currently
available products, Surfaxin demonstrated a significant survival advantage
for
RDS babies. If approved by the FDA, Surfaxin represents a potential alternative
to the current surfactant treatment options for RDS.
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 Labs’ technology produces a precision-engineered surfactant
that is designed to closely mimic the essential properties of natural human
lung
surfactant. Discovery Labs 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
Labs’ 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. Surfaxin is also being developed for the prevention and
treatment of Bronchopulmonary Dysplasia (BPD, also known as Chronic Lung
Disease) in premature infants. Discovery Labs is preparing to conduct multiple
Phase 2 pilot studies with Aerosurf™, aerosolized SRT administered through nasal
continuous positive airway pressure (nCPAP), for the treatment of neonatal
respiratory failure.
To
address the various respiratory conditions affecting pediatric, young adult
and
adult patients in the critical care and other hospital settings, Discovery
Labs
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 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 and
development partners to 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 the Company 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.
Company
Contacts:
Lisa
Caperelli, Manager, Investor Relations
215-488-9413
