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
December 10, 1997
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)
509 Madison Avenue
14th Floor
New York, NY 10022
(Address of principal executive offices)
(212) 223-9504
(Registrant's telephone number, including area code)
Item 5. Other Events
Discovery Laboratories, Inc. ("Discovery") announced today that its
majority-owned privately held subsidiary, Acute Therapeutics, Inc. ("ATI"), has
completed enrollment of its Phase IB clinical trial in acute respiratory
distress syndrome. The Phase IB clinical trial is designed to determine the
safety and tolerability of a bronchoscopic lavage procedure incorporating
Surfaxin(TM). ATI has exclusively licensed worldwide distribution rights to
Surfaxin(TM) from Johnson & Johnson.
Reference is made to Discovery's related press release attached
hereto as Exhibit 99.1 and incorporated by reference herein.
Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits
(c) Exhibits:
99.1 Press Release dated December 10, 1997.
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.
Date: December 10, 1997
By: /s/ James S. Kuo, M.D.
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Name: James S. Kuo, M.D.
Title: President and Chief Executive Officer
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Exhibit Index
Exhibit Number Description
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99.1 Press Release dated December 10, 1997.
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EXHIBIT 99.1
DISCOVERY LABORATORIES, INC.
FOR IMMEDIATE RELEASE
Contact:
James S. Kuo, M.D.
President and Chief Executive Officer
Discovery Laboratories, Inc.
(212) 223-9504
Dan Griesel, Ph.D.
The Investor Relations Group, Inc.
(212) 664-8489
Discovery Laboratories, Inc. Announces Completion of
Enrollment of Patients in a Phase IB Acute Respiratory Distress
Syndrome Clinical Trial by Its Subsidiary, Acute Therapeutics, Inc.
NEW YORK, NEW YORK, Dec. 10, 1997--Discovery Laboratories, Inc. (NASDAQ: DSCO
and DSCOU) announced that its majority-owned privately held subsidiary, Acute
Therapeutics, Inc., has completed enrollment of its Phase IB clinical trial in
acute respiratory distress syndrome (ARDS). The Phase IB clinical trial is
designed to enroll 12 ARDS patients and determine the safety and tolerability of
a bronchoscopic lavage procedure incorporating Surfaxin(TM). Patients with ARDS
are assigned to receive one of three dosing regimens of Surfaxin(TM) with 28
days of follow-up. The open label study is being conducted at seven academic
hospitals in the United States. Dr. Robert Capetola, chairman and CEO of Acute
Therapeutics, stated, "The completion of patient enrollment in this Phase IB
clinical trial in ARDS marks a major milestone for the Company. We would expect
to announce results of this Phase IB clinical trial in the two or three months,
if not sooner."
Surfaxin(TM) is a novel, proprietary, peptide-containing lung surfactant
invented at The Scripps Research Institute. The peptide is KL4, a 21 amino acid
peptide, modeled after the important SP-B protein in the human surfactant
system. Lung surfactants are protein-lipid complexes that coat the airsacs of
the lung and facilitate oxygen exchange with blood. ARDS is an acute generalized
inflammatory disease of the lung which can lead to the degradation of lung
surfactants. Common conditions that can cause ARDS are pneumonia, aspiration of
gastric contents, smoke inhalation and trauma. The human and economic cost of
ARDS is significant with a reported incidence of 150,000 cases per year in the
United States and a mortality rate of approximately 50 percent. There are no
Food and Drug Administration (FDA) approved therapies for ARDS.
Surfaxin(TM) is also currently in a Phase II trial for meconium aspiration
syndrome (MAS). MAS results from the release of meconium, a greenish, pasty
constituent of the fetal bowel, into the amniotic fluid. When present in
amniotic fluid, babies can inhale the meconium into their lungs, which can lead
to pneumonitis and subsequent degradation of lung surfactant. MAS affects
approximately 26,000 newborn babies per year in the United States and an equal
number in Europe. There are no specific FDA approved therapies. Surfaxin(TM) has
been successfully tested in a Phase II trial in infant respiratory distress
syndrome (IRDS) by Johnson & Johnson prior to the licensure of the technology.
Acute Therapeutics is planning to develop Surfaxin(TM) in IRDS in the near
future.
Discovery Laboratories, Inc. is a New York City based development stage
pharmaceutical company that is clinically developing proprietary pharmaceuticals
to treat post-menopausal osteoporosis, adult respiratory distress syndrome,
meconium aspiration syndrome and cystic fibrosis. Discovery's strategy is
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to accelerate and lower the risk of drug development by acquiring and developing
proprietary pharmaceuticals for which significant animal or human testing has
already been completed. In addition, Discovery seeks to minimize the cost of
drug development by outsourcing preclinical development and manufacturing.
Hospital based pharmaceuticals are developed at Discovery's majority-owned
privately held subsidiary, Acute Therapeutics, Inc., located in Doylestown, Pa.
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 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 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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