SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
___________________________
FORM
8-K/A
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
March
28, 2008
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
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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))
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Item
1.01.
|
Amendment
of a Material
Agreement.
|
On
April
3, 2008, Discovery Laboratories, Inc. (the “Company”) filed a current report on
Form 8-K (the “Initial Report”) regarding the entry into an Amended and Restated
License Agreement with Philip Morris USA Inc., d/b/a Chrysalis Technologies.
The
Company is filing this amendment solely to attach the April 2, 2008 Press
Release referenced as Exhibit 99.1 to the Initial Report. The Press Release
is
filed as Exhibit 99.1 to this report and incorporated herein by
reference.
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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Item
9.01.
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Financial
Statements and
Exhibits.
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|
(d)
|
Exhibits:
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99.1
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Press
Release of Discovery Laboratories, Inc., dated April 2,
2008.
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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 | |
|
Robert J. Capetola, Ph.D. |
||
| President and Chief Executive Officer | ||
Date:
April 11, 2008
Exhibit
99.1
Discovery
Labs and Chrysalis Technologies Modify Collaboration for Future
Development
of Aerosolized Drug Device Products
Warrington,
PA — April 2, 2008 — Discovery Laboratories, Inc. (Nasdaq: DSCO)
and
Chrysalis Technologies (a division of Philip Morris USA, Inc.) have been
collaborating to develop combination drug device products that unite Discovery
Labs’ precision-engineered synthetic surfactant with Chrysalis’ novel capillary
aerosolization technology to address respiratory diseases. To date, the
collaboration has focused on developing a prototype device for use in Discovery
Labs’ upcoming Phase 2 clinical trials for Aerosurf™, aerosolized Surfactant
Replacement Therapy (SRT) for premature infants. Under the modified
collaboration, Discovery Labs will assume full responsibility, effective July
1,
2008, to further develop the capillary aerosolization technology into devices
for potential clinical and commercial application.
Robert
J. Capetola, Ph.D., President and Chief Executive Officer of Discovery Labs,
commented, “Our aerosolized SRT combined with this robust capillary
aerosolization technology has the potential to transform respiratory medicine.
We believe in the potential of this technology and now have full development
control. Combining our surfactant expertise with Chrysalis’ unique technology
knowhow has been appropriate for the development of the initial prototype device
system. In anticipation of developing the next generation device for late stage
clinical and commercial applications, we have been building our own internal
medical device engineering expertise. We have also begun working with a leading
engineering and design firm that has a successful track record of developing
innovative devices for major companies in the medical and pharmaceutical
industries.”
The
modification provides for Chrysalis’ continued development support through June
30, 2008, after which Chrysalis will cease operations for reasons unrelated
to
this collaboration and the Chrysalis technology. Additionally, the modification
provides for transfer to Discovery Labs of the aerosol technology know-how,
engineering design work, and related materials. Chrysalis’ continued support and
the technology transfer are in line with the current development plans to
optimize the initial prototype device, which upon success, will be used in
Discovery Labs’ anticipated Aerosurf Phase 2 clinical trials.
Discovery
Labs retains its exclusive worldwide rights to the capillary aerosolization
technology for use with pulmonary surfactants for all respiratory diseases
and
now has also received expanded rights in the United States to the capillary
aerosolization technology for use with other drugs for respiratory diseases
in
the hospital setting.
Keeping
with the original intent of the collaboration, under which Chrysalis was
primarily responsible for device development, Chrysalis has also agreed to
provide $4.5 million to Discovery Labs to support further development. The
modification also significantly reduces the original royalties due Chrysalis
from a multi-tiered royalty structure (that escalated upon attaining
collaboration product revenues greater than $500 million and $1 billion) to
a
low single-digit base royalty that now applies to all product revenues.
Discovery Labs believes this reduction in royalties may facilitate future
potential collaborative arrangements to co-develop and/or commercialize
aerosolized SRT.
Discovery
Labs’ Proprietary Aerosolized KL-4 Surfactant Technology - Aerosurf™ and Future
Applications
Aerosolized
KL-4 surfactant technology has the therapeutic potential to reestablish airway
patency, improve pulmonary mechanics and act as an anti-inflammatory in a host
of respiratory diseases that are associated with surfactant dysfunction and
a
loss of patency. Serious respiratory problems are some of the most prevalent
medical issues facing premature infants in the Neonatal Intensive Care Unit
(NICU). There are more than 1 million premature infants born annually worldwide
at risk for respiratory problems associated with surfactant dysfunction.
Neonatologists generally try to avoid mechanically ventilating these patients
because doing so requires intubation (the invasive insertion of a breathing
tube
down the trachea). The potential utility of a non-invasive method of delivering
SRT to treat premature infants suffering from an array of respiratory disorders
has been recognized by the neonatal medical community. Aerosurf is a
precision-engineered aerosolized SRT administered via nasal continuous positive
airway pressure (nCPAP) which is being developed to potentially treat premature
infants with respiratory conditions in the NICU. Discovery Labs plans to apply
the experience obtained in the development of Aerosurf to potentially develop
aerosolized SRT to treat several pediatric and adult respiratory disorders,
including Cystic Fibrosis, ALI, COPD, and asthma.
The
novel, proprietary capillary aerosolization technology is designed to produce
high-volume aerosols and has the potential to enable targeted upper respiratory
or deep lung delivery of therapies. Aerosols are created by pumping the drug
formulation through a small, heated capillary. Upon exiting the capillary,
the
vapor stream quickly cools and slows in velocity, yielding a dense aerosol.
The
particle size can be readily controlled and adjusted through device
modifications and drug formulation changes.
In
May 2007, Discovery Labs presented to the medical community data from
pre-clinical studies using aerosolized KL-4 surfactant. In these studies, KL-4
surfactant was aerosolized to compare its capillary aerosolization technology
to
commercially available aerosol generator devices. The studies demonstrated
that
KL-4 surfactant maintains its chemical structure and essential functional
activity post-aerosolization. In addition, the capillary aerosolization
technology generated a nearly 10-fold higher aerosol output rate than the other
study devices.
Discovery
Labs’ design engineers, together with Chrysalis and contract manufacturers,
continue to optimize the initial prototype device incorporating the capillary
aerosolization technology. Discovery Labs’ contract manufacturer is preparing to
manufacture prototype devices and once development milestones have been
achieved, the devices will be used in planned Phase 2 clinical trials.
Additionally, Discovery Labs has met with and received guidance from the U.S.
Food and Drug Administration (FDA) with respect to the design of a proposed
Phase 2 clinical program. Discovery Labs is also engaged in further development
of the capillary aerosolization technology, including conceptualization and
development of the next-generation device, which it plans to use in potential
Phase 2 and Phase 3 clinical trials and, if approved, in future commercial
activities.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing 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’ lead product candidate, Surfaxin®,
is the subject of an Approvable Letter from the FDA for the prevention of
Respiratory Distress Syndrome in premature infants and has a targeted approval
PDFUA date of May 1, 2008. Surfaxin is also being developed for other neonatal
and pediatric indications. Aerosurf™, Discovery Labs’ aerosolized SRT, is being
developed to potentially obviate the need for intubation and conventional
mechanical ventilation and holds the promise to significantly expand the use
of
surfactants in respiratory medicine. For more information, please visit our
website at www.Discoverylabs.com.
To
the extent that statements in this press release are not strictly historical,
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,
including, without limitation, the risks that: Discovery Labs may be unable
to
profitably develop and market its products; Discovery Labs may not be able
to
raise additional capital or enter into additional collaboration agreements
(including strategic alliances for development or commercialization of SRT);
changes in the national or international political and regulatory environment
may make it more difficult to gain FDA or other regulatory approval of drug
products; Discovery Labs’ significant, time-consuming and costly research and
development activities, including pre-clinical studies, clinical trials and
other efforts to gain regulatory approval for any products may not progress
or
may be subject to potentially significant delays or regulatory holds, or fail;
Discovery Labs may not succeed in the FDA or other regulatory agency review
process, including that such regulatory authority may not approve the marketing
and sale of a drug product or may withhold, delay and/or limit marketing of
a
drug product by indication or impose other label limitations; Discovery Labs’
recently-submitted Complete Response to the Approvable Letter may not satisfy
the FDA; Discovery Labs may be unable to successfully transfer its manufacturing
technology to third-party contract manufacturers or its contract manufacturers
or any of its materials suppliers may encounter problems manufacturing drug
products or drug substances on a timely basis or manufacture in amounts
sufficient to meet demand; Discovery Labs and its collaborators may be unable
to
develop, manufacture and successfully commercialize products that combine
Discovery Labs’ drug products with innovative aerosolization technologies;
Discovery Labs may be unable to develop a successful sales and marketing
organization in a timely manner and its marketing and advertising consultants
may not succeed in developing market awareness of its products; upon approval
of
a product candidate, Discovery Labs may not adequately forecast customer demand;
Discovery Labs or its development partners, collaborators or marketing partners
may not be able to attract or maintain qualified personnel; Discovery Labs
may
be unable to maintain and protect the patents and licenses related to its SRT;
other companies may develop competing therapies and/or technologies or health
care reform may adversely affect Discovery Labs; and Discovery Labs may become
involved in securities, product liability and other litigation. The foregoing
risks and others are further described in Discovery Labs 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
Contact:
Lisa
Caperelli, Investor Relations
215-488-9413