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 19, 2002
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)
Item 5. Other Events
On December 19, 2002, Registrant issued a press release to announce an
interruption in the supply of its Surfaxin(R) drug product for Part B of
Registrant's ongoing Phase 2 clinical trial for Acute Respiratory Distress
Syndrome (ARDS) in adults. Registrant presently anticipates that the completion
of this part of the ARDS Phase 2 trial will now occur in the second quarter of
2003, a delay of approximately three months. The interruption in supply is not
expected to have an effect on Registrant's other ongoing Phase 3 clinical trials
for Surfaxin, including the two pivotal, landmark multinational Phase 3 trials
for Respiratory Distress Syndrome (RDS) in premature infants and the Phase 3
clinical trial for Meconium Aspiration Syndrome (MAS) in full-term infants.
Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits
(c) Exhibits:
99.1 Press Release dated December 19, 2002.
2
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: December 20, 2002
3