UNITED STATES
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
February 19, 2004
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 (Commission File Number) (IRS Employer
of incorporation) Identification Number)
350 Main Street, Suite 307
Doylestown, Pennsylvania 18901
(Address of principal executive offices)
(215) 340-4699
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
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Item 5. Other Events and Regulation FD Disclosure
On February 19, 2004, the Company will hold a conference call to
provide an overview of the secondary endpoints and certain safety results from
the Company's two Phase 3 clinical trials for Respiratory Distress Syndrome in
premature infants (RDS). In June 2003, the Company announced positive top-line
results in its supportive non-inferiority Phase 3 RDS trial. In November 2003,
the Company announced that it had achieved statistical significance in its
coprimary endpoints in its pivotal superiority Phase 3 RDS trial. The secondary
endpoint results from these two Phase 3 RDS trials are consistent with and
supportive of the earlier positive pivotal and supportive top-line results. In
addition, the Company intends to provide an update on selected other programs.
In October 2003, the Company and Laureate Pharma, L.P. ("Laureate"),
entered into a Technology Transfer and Manufacturing Agreement providing for the
installation and validation of the Company's Surfaxin(R) manufacturing and
filling line at Laureate's facility for the production of clinical and
commercial drug supply in conformance with current Good Manufacturing Practices
(cGMP). The installation of this manufacturing and filling line has been
completed. In addition, a key objective of producing two batches of Surfaxin for
RDS, in order to provide stability data to support the anticipated NDA
submission to the FDA, has been completed.
Validation of the Laureate Surfaxin manufacturing facility is
ongoing, with the completion of process sterility assurance remaining as the
final step. The Company originally anticipated that process sterility assurance
would be completed and drug supply would be available in late fourth quarter of
2003. The Company now anticipates completing process sterility assurance and
producing Surfaxin for the Company's ARDS Phase 2 trial in the first quarter of
2004. As a result, completion of the Company's ARDS Phase 2 trial is now
anticipated for the second half of 2004.
The Company relies on outside manufacturers for its drug substance
and other active ingredients for Surfaxin and to produce material that meets
appropriate standards for use in clinical studies of its products. Presently,
the Company has no validated clinical manufacturing facility to produce
appropriate clinical grade material of its drug substance for use in the
Company's ongoing clinical studies. Laureate may not be able to produce Surfaxin
to appropriate standards for use in clinical studies or commercial requirements.
This could delay, or impair the ability of the Company, to obtain regulatory
approval for its products and possibly increase its costs substantially or
deplete any profit margins.
On February 6, 2004, the Company issued a press release which is
attached hereto as Exhibit 99.1, to announce that the U.S. Food and Drug
Administration has selected Surfaxin, for the treatment of Acute Respiratory
Distress Syndrome (ARDS), as the only applicant within the Division of Pulmonary
and Allergy Drug Products to be included in the FDA's Continuous Marketing
Application (CMA) Pilot 2 Program. The Pilot 2 program was established to study
and document the benefits of more frequent FDA feedback and interactions as a
company moves through the various phases of development, with the goal that such
interactions will expedite the development of Fast Tracked products.
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Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits
(c) Exhibits: Press Release dated February 19, 2004.
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: February 19, 2004
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Exhibit 99.1
[DISCOVERY LABORATORIES LOGO]
FDA Selects Discovery Laboratories' Surfaxin(R) ARDS Program
For Its New Continuous Marketing Application Pilot 2 Program
Doylestown, PA -- February 19, 2004 -- Discovery Laboratories, Inc. (Nasdaq:
DSCO), a biopharmaceutical company developing its proprietary humanized
surfactant technology as Surfactant Replacement Therapies for respiratory
diseases, today announced that the U.S. Food and Drug Administration has
selected Surfaxin(R) for the treatment of Acute Respiratory Distress Syndrome
(ARDS), as the only applicant within the Division of Pulmonary and Allergy Drug
Products to be included in its Continuous Marketing Application (CMA) Pilot 2
Program. Participation in this initiative is limited to one Fast Track product
for each review division within the Center for Drug Evaluation and Research
(CDER) and Center for Biologics Evaluation and Research (CBER) over the course
of the program.
The Pilot 2 program was established to study and document the benefits of more
frequent FDA feedback and interactions as a company moves through the various
phases of development, with the goal that such interactions will expedite the
development of Fast Track products.
"We are gratified to have been selected for this innovative program. Given the
devastating effects of ARDS both in terms of mortality and disease-related
complications, inclusion into this program is an opportunity to collaborate
closely with the FDA in defining the scope of the development program and
endpoints to capture the essence of surfactant replacement therapy for these
patients," said Robert J. Capetola, Ph.D., President and Chief Executive Officer
of Discovery. "We look forward to an increased level of scientific exchange and
interaction with the FDA to ensure a high quality ARDS program and agreed upon
path toward approval."
The objective of the Pilot 2 program is to evaluate the costs and benefits of
enhanced sponsor access to guidance and feedback from the FDA during the
Investigational New Drug (IND) phase of new drug development of Fast Track
products and determine whether such activity can improve the efficiency of the
drug development and review process. Once selected, participants in the Pilot 2
program and the FDA define specific agreements on the nature and timing of
feedback and interactions between the participants and the FDA. Eligibility is
limited to drug and biological products that have Fast Track designation and
have been subject to an end of phase 1 clinical trial or equivalent meeting.
Criteria for selection included the FDA's assessment of the potential value of
enhanced interaction with an emphasis on the health benefits likely to result
from successful drug development. For more information on CMA Pilot 2, visit
http://.fda.gov/cder/guidance/5740-fnl.pdf.
About Acute Respiratory Distress Syndrome
ARDS is a life-threatening respiratory disorder for which there are currently no
approved therapies anywhere in the world. It is estimated that there are between
150,000 and 250,000 ARDS patients per year in each of the U.S. and Europe. The
mortality rate can range from 35% to 50%. The current standard of care includes
placing patients on mechanical ventilators in intensive care units at an average
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estimated cost of approximately $8,500 per day typically for an average of 21 to
28 days. One prominent characteristic of ARDS is the destruction of the lung's
natural surfactant that is essential to the ability to absorb oxygen. ARDS is
also characterized by an excess of fluid, inflammatory cells and debris in the
lungs that leads to decreased oxygen levels in the patient's blood. These
conditions are caused by events such as pneumonia, aspiration of gastric
contents, smoke inhalation, near drowning, industrial accidents, sepsis and
other traumas.
About Discovery Laboratories
Discovery Laboratories, Inc., is a biopharmaceutical company developing its
proprietary surfactant technology as Surfactant Replacement Therapies for
respiratory diseases including Respiratory Distress Syndromes in infants and
adults, Acute Lung Injury, asthma, Chronic Obstructive Pulmonary Disease and
upper airway disorders. Surfactants are compositions produced naturally in the
lungs and essential for breathing. Discovery's technology produces an engineered
version of natural human lung surfactant that is designed to provide the
essential properties of human lung surfactant. Discovery believes that through
its technology, pulmonary surfactants have the potential, for the first time, to
be developed into a series of respiratory therapies for critical care and other
hospitalized patients where there are few or no approved therapies available.
Discovery recently completed two Phase 3 clinical trials of Surfaxin(R), the
Company's lead product, for the treatment of Respiratory Distress Syndrome in
premature infants and is preparing to file new drug applications with the Food
and Drug Administration and other regulatory authorities in the rest of the
world. Discovery's Surfactant Replacement Therapy is also in a Phase 2 clinical
trial for Acute Respiratory Distress Syndrome in adults, a Phase 3 and a Phase 2
clinical trial for Meconium Aspiration Syndrome in full-term infants, and a
Phase 1b clinical trial for asthma.
More information about Discovery is available on the Company's Web site 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 the Company's product development,
events conditioned on stockholder or other approval, 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 release 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 the company's
actual results and could cause results to differ from those contained in the
forward-looking statements contained herein are the risk that financial
conditions may change, risks relating to the progress of the company's research
and development, the risk that the Company will not be able to raise additional
capital or enter into additional collaboration agreements (including strategic
alliances for our aerosol and Surfactant Replacement Therapies), risks relating
to the progress of the Company's research and development, risks relating to the
ability of the Company's third party contract manufacturers to provide the
Company with sufficient amounts of drug products for completion of any of the
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Company's clinical studies, other risks relating to the lack of sufficient drug
product for completion of any of the Company'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 the company's filings
with the Securities and Exchange Commission including the most recent reports on
Forms 10-K, 10-KSB, 8-K, 10-Q and 10-QSB, and amendments thereto.
Company Contacts:
John G. Cooper, EVP, CFO
Kori Beer, IR & Communications
215-340-4699