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
Date of Report (Date of Earliest Event Reported) January 27, 2000
Discovery Laboratories, Inc.
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(Exact Name of Registrant as Specified in its Charter)
Delaware 000-26422 13-3711775
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(State or Other (Commission (I.R.S. Employer
Jurisdiction of File Number) Identification
incorporation) No.)
350 Main Street, Suite 307, Doylestown, Pennsylvania 18901
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(Address of Principal Executive Offices) (Zip Code)
(Registrant's Telephone Number, Including Area Code) (215) 240-4699
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(Former Name or Former Address, If Changed Since Last Report.)
914917.1
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ITEM 5. Other Events.
Attached is a press release issued by Discovery Laboratories, Inc.
(the "Company") on January 27, 2000 with respect to a pivotal Phase III Trial on
Surfaxin(R) for Meconium Aspiration Syndrome and discontinuance of a Phase
II/III clinical trial on Surfaxin(R) for acute respiratory distress syndrome and
a press release issued on January 12, 2000 with respect to grant of a patent.
ITEM 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(c) Exhibits.
Exhibit Description
1.1 Press release issued by the Company on January 27, 2000
1.2 Press release issued by the Company on January 12, 2000
914917.1
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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 Capetola
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Name: Robert Capetola
Title: President and Chief Executive
Officer
Date: February 7, 2000
914917.1
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EXHIBIT INDEX
Exhibit 1.1 Press release issued by the Company on January 27, 2000
Exhibit 1.2 Press release issued by the Company on January 12, 2000
914917.1
FOR IMMEDIATE RELEASE:
Contact: Christopher J. Schaber
Executive Vice President,
Drug Development and Regulatory Compliance
Discovery Laboratories, Inc.
215.340.4699, Ext. 130
Dian Griesel, Ph.D., CEO/
Shayne Payne
The Investor Relations Group
212.736.2650
DISCOVERY LABORATORIES, INC. TO BEGIN PIVOTAL PHASE 3 STUDY
OF SURFAXIN(R) IN MECONIUM ASPIRATION SYNDROME
Doylestown, PA, January 27, 2000 - Discovery Laboratories, Inc. (Discovery)
(Nasdaq small cap: DSCO, DSCOU) announces the initiation of a pivotal Phase 3
trial to evaluate the efficacy of the company's novel pulmonary surfactant,
Surfaxin(R) (lucinactant), in the treatment of full-term infants with Meconium
Aspiration Syndrome (MAS). The trial will enroll approximately 200 newborn
infants at more than thirty medical centers throughout the United States in
order to compare Surfaxin(R)-lavage (lung wash) with standard care.
Approximately 13% of babies pass a bowel movement (known as meconium) while
still inside their mothers' uterus. Some fetuses and newborns will inhale this
substance into their lungs and subsequently develop MAS. This disorder is
characterized by the presence of meconium, inflammatory cells, inflammatory
mediators, edema fluid, protein, and other noxious debris in the lungs. Inhaled
meconium can inactivate the infants' own natural surfactant (the substance that
keeps lung air sacs open) and make breathing difficult. Many of the affected
babies develop severe respiratory distress, necessitating the need for
mechanical ventilation. There are no approved therapies for this disorder
worldwide.
Previously, Surfaxin(R) was shown to be safe and well tolerated in a similar
open label Phase 2 trial that used the novel surfactant to cleanse the lungs
(using bronchoalveolar lavage or lung wash) of MAS patients requiring mechanical
ventilation. In order to assess the safety and potential efficacy of Surfaxin(R)
therapy, fifteen of twenty-two patients randomized to receive Surfaxin(R)-lavage
were compared to seven patients randomized to standard of care.
Surfaxin(R)-lavaged newborns had more rapid and more persistent improvements in
oxygenation compared to standard of care patients. Lavaged infants were, on
average, weaned from mechanical ventilation 3 days sooner than controls. These
promising preliminary results prompted the initiation of the new Phase 3 trial.
Surfaxin(R), which contains sinapultide (a peptide mimic of the human surfactant
protein B), was granted fast track designation by the U.S. Food and Drug
Administration (FDA) on October 8, 1998 for the treatment of MAS. Fast track
status facilitates the development and expedites the review of new drugs
intended for the treatment of life-threatening conditions for which there are
more
no current medical options. The FDA has also granted Discovery orphan drug
designation for this indication and has awarded the Surfaxin(R) MAS development
program a three-year orphan drug grant totaling approximately $560,000.
In addition, Discovery has elected to halt its current ARDS clinical trial as a
result of a breakthrough in the manufacturing process of Surfaxin(R). "We can
now manufacture a less viscous formulation of Surfaxin(R)", said Robert J.
Capetola, Ph.D., President and CEO of Discovery. "This new process will allow us
to deliver a higher concentration of Surfaxin(R) through our patented lavage
process. To that end we are planning to initiate a new clinical trial in
ARDS/ALI with this less viscous product subject to appropriate funding. This
should greatly benefit patients and further improve the chances of success for
Surfaxin(R) in the ARDS clinical trials."
Discovery is a bio-pharmaceutical company whose mission is to develop and
commercialize medically novel therapeutics for critical care. Presently,
Discovery is developing proprietary pharmaceuticals to treat respiratory
distress syndrome (RDS) in premature infants, MAS in full-term infants, direct
acute respiratory distress syndrome (ARDS), and cystic fibrosis. 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 future financial conditions, 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
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 and the
development of competing therapies and/or technologies by other companies. Those
associated risks and others are further described in the company's filings with
the Securities and Exchange Commission.
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FOR IMMEDIATE RELEASE:
- ----------------------
Contact: Christopher J. Schaber
Executive Vice President,
Drug Development and Regulatory Compliance
Discovery Laboratories, Inc.
215.340.4699, Ext. 130
Dian Griesel, Ph.D., CEO/
Shayne Payne
The Investor Relations Group
212.736.2650
DISCOVERY LABORATORIES RECEIVES
BROAD PATENT COVERING SURFACTANT LAVAGE
Patent covers all known surfactants for use in any form of pulmonary lavage.
Doylestown, PA, January 12, 2000 - Discovery Laboratories, Inc. (NASDAQ Small
Cap: DSCO, DSCOU) today announced the issuance of United States Patent No.
6013619 entitled "Novel Pulmonary Surfactants and Therapeutics Uses, Including
Pulmonary Lavage." The issued claims enable Discovery to broaden its protection
of its prime development product, Surfaxin(R). This patent also covers all other
known surfactants for use in any form of pulmonary lavage. This includes all
synthetic, animal- or human-derived surfactants designed to treat a variety of
respiratory distress syndromes, including respiratory distress syndrome (RDS) in
premature infants, acute lung injury (ALI)/acute respiratory distress syndrome
(ARDS), meconium aspiration syndrome (MAS), neonatal respiratory distress
associated with acute hypoxemia, persistent pulmonary hypertension, or
congenital diaphramatic hernia, as well as a variety of other conditions
associated with pulmonary injury. Pulmonary lavage techniques (using any
surfactant) include lavage via a bronchoscope as well as direct pulmonary lung
lavage via an endotracheal tube.
"This completes the four sided intellectual property position of Surfaxin(R). In
addition to our composition of matter, utility, and process technology patent
portfolio on Surfaxin(R), this issuance positions us as the future global leader
in surfactant therapy since the allowed claims cover all known surfactants,"
said Dr. Robert Capetola, CEO of Discovery Laboratories, Inc. "We now have what
we consider to be a very complete proprietary position on our lead respiratory
product."
Discovery pioneered the surfactant lavage technique, which is also known as
"lung wash". Many respiratory diseases such as MAS and ALI/ARDS are associated
with massive pulmonary inflammation, which includes white blood cells, edema,
protein and debris. "The lungs are infiltrated with inflammatory material in
these conditions and need to be drained just as an abscess would have to be. One
way to safely drain them is with a surfactant lavage", added Capetola. Due to
inflammation associated with respiratory distress syndromes such as MAS and
-more-
ALI/ARDS, these patients have depleted or degraded endogenous surfactant in
their lungs and thus require mechanical ventilation. Discovery's intent, with
its lavage technique, is to rid the lung of the infectious and inflammatory
debris, restore the alveoli to a more normal state and get patients off
mechanical ventilation sooner.
Discovery has safely employed the surfactant lavage technique in two clinical
trials thus far, a Phase 1B trial in ARDS/ALI patients and a Phase 2 trial in
newborn MAS babies. Plans are currently underway to initiate a Phase 3 pivotal
trial in MAS.
Surfaxin(R) (lucinactant) contains the novel, proprietary peptide sinapultide
which was designed to completely mimic the human surfactant protein B (SP-B).
Clinical proof of concept has been demonstrated in a Phase 2 trial in premature
infants with respiratory distress syndrome (RDS), and in a Phase 2 trial of
full-term babies with MAS. Existing surfactants are approved only for RDS in
premature babies, with the most commonly-used surfactants being extracts from
either cow or pig lungs. Discovery's synthetic humanized surfactant,
Surfaxin(R), was designed to replace the animal-derived surfactants and to
expand surfactant use into other pulmonary disorders.
Discovery is a bio-pharmaceutical company whose mission is to develop and
commercialize medically novel therapeutics for critical care. Presently,
Discovery is developing proprietary pharmaceuticals to treat RDS in premature
infants, MAS, direct ARDS, and cystic fibrosis. 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 future financial conditions, 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
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 and the
development of competing therapies and/or technologies by other companies. Those
associated risks and others are further described in the company's filings with
the Securities and Exchange Commission.
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