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
15, 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))
2
Item
8.01. Other
Events.
On
June
15, 2006, Discovery Laboratories, Inc. (the “Company”) issued a press release
announcing that the Office of Orphan Products Development of the United States
Food and Drug Administration has granted orphan drug designation to the
Company’s lead product, Surfaxin®, for the prevention of Bronchopulmonary
Dysplasia (BPD, also known as Chronic Lung Disease) in premature infants. The
U.S. Orphan Drug Act is intended to assist and encourage companies to develop
safe and effective therapies for the treatment of rare diseases and disorders.
Surfaxin, a precision-engineered lung surfactant replacement therapy, has
previously received orphan drug designation for the treatment of BPD, as well
as
fast track designation for both the prevention and treatment of BPD. The Company
recently concluded its Phase 2 double-blind, placebo-controlled trial enrolling
very low birth weight premature infants born at risk for developing BPD, and
plans to report results in the fourth quarter of 2006. The press release, dated
June 15, 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 15, 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.
| Discovery Laboratories, Inc. | ||
| |
|
|
| By: | /s/ Robert J. Capetola | |
|
Name:
Robert J. Capetola, Ph.D.
Title:
President and Chief Executive Officer
|
||
| Date: June 16, 2006 | ||
3
Exhibit
99.1
Discovery
Labs’ SurfaxinÒ Granted
Orphan Drug Designation for the Prevention of Bronchopulmonary
Dysplasia
Warrington,
PA, June 15, 2006 — Discovery Laboratories, Inc. (Nasdaq:
DSCO),
today
announced that the Office of Orphan Products Development of the United States
Food and Drug Administration (FDA) has granted orphan drug designation to
Discovery’s lead product, Surfaxin®,
for the
prevention of Bronchopulmonary Dysplasia (BPD, also known as Chronic Lung
Disease) in premature infants. Surfaxin, a precision-engineered lung surfactant
replacement therapy, has previously received orphan drug designation for the
treatment of BPD, as well as fast track designation for both the prevention
and
treatment of BPD.
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 prevent and treat RDS, babies require a surfactant
usually within the first hours of birth, and mechanical ventilation to support
their respiration. The lack of surfactant and use of mechanical ventilation
may
cause chronic injury and scarring of the lungs - resulting in BPD.
The
U.S.
Orphan Drug Act is intended to assist and encourage companies to develop safe
and effective therapies for the treatment of rare diseases and disorders. Orphan
drug designation in the United States is awarded to compounds that offer
potential therapeutic value in the treatment of rare diseases, defined as those
affecting fewer than 200,000 Americans. If the company complies with certain
FDA
specifications and should the drug receive marketing approval, orphan drug
designation qualifies the sponsor for seven years of marketing exclusivity,
exemption from the Prescription Drug User Fee Act filing fees, and tax credits
related to clinical research.
Robert
J.
Capetola, Ph.D. President and Chief Executive Officer of Discovery commented,
“Market exclusivity under this designation would mean that Surfaxin, as a
precision-engineered surfactant, has the potential to become the dominant
surfactant in the neonatal intensive care unit for the next decade. If Surfaxin
is the first product to receive marketing authorization in the United States
for
the treatment of Bronchopulmonary Dysplasia, orphan status would block any
similar synthetic surfactant products for this indication throughout the United
States market for a significant period of time.”
Discovery
recently concluded its Phase 2 double-blind, placebo-controlled trial early,
enrolling approximately 130 very low birth weight premature infants born at
risk
for developing BPD. The purpose of the trial was to determine the safety and
tolerability of administering Surfaxin as a therapeutic approach for the
prevention and treatment of BPD. Premature infants in this study received a
treatment regime of up to 5 Surfaxin doses beginning within the first 3-10
days
of life, in addition to the surfactant they received on day 1 of life for RDS.
Discovery plans to report the top-line results in the fourth quarter of 2006.
Surfaxin
is a precision-engineered, peptide-containing, synthetic surfactant that is
designed to closely mimic the function of natural human lung surfactant.
Discovery’s Surfaxin has received two Approvable Letters from the FDA for the
prevention of RDS in premature infants. 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.
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
lead product, Surfaxin®,
for the
prevention of Respiratory Distress Syndrome (RDS) in premature infants, has
received two Approvable Letters from the FDA.
Discovery’s
proprietary SRT is also being developed in an aerosolized form under the name
Aerosurf™, for the treatment of neonatal respiratory disorders. Discovery is
preparing to conduct Phase 2 pilot studies with Aerosurf™, aerosolized SRT
administered through nasal continuous positive airway pressure (nCPAP). In
addition, also for premature infants, Discovery recently concluded early a
Phase
2 clinical trial of Surfaxin for the prevention and treatment of
Bronchopulmonary Dysplasia (BPD), also known as Chronic Lung Disease. Discovery
recently completed and announced preliminary results of a Phase 2 clinical
trial
to address Acute Respiratory Distress Syndrome (ARDS) in adults, and is also
developing aerosol formulations of SRT to potentially address Acute Lung Injury
(ALI), cystic fibrosis 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 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 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, Investor Relations
215-488-9413